Greater Reduction In Waist Circumference Research Articles

Health Effects of Electrolyzed Hydrogen Water for the Metabolic Syndrome and Pre-Metabolic Syndrome: A 3-Month Randomized Controlled Trial and Subsequent Analyses.

We studied the effect of three months' use of electrolyzed hydrogen water (EHW, Electrolyzed Hydrogen Water conditioner produced by Nihon Trim Co., Ltd.) on metabolic and pre-metabolic syndrome groups. This research was carried out jointly by Susaki City; Nihon Trim Co., Ltd.; and Kochi University as part of a local revitalization project with health as a keyword. A randomized, placebo-controlled, double-blind, parallel-group trial was conducted to evaluate the clinical impact of EHW on participants who suffered from metabolic syndrome or pre-metabolic syndrome. EHW was produced via electrolysis using a commercially available apparatus (Nihon Trim Co., Ltd., Osaka, Japan). During exercise, oxidative stress increases, and active oxygen species increase. In this study, we examined 181 subjects with metabolic syndrome or pre-metabolic syndrome. Among the group that drank EHW for 3 months, those who also engaged in a high level of physical activity showed a significant difference in waist circumference reduction. Although no significant difference was observed, several positive results were found in the participants who engaged in a high level of physical activity. Urinary 8-OHdG, urinary nitrotyrosine, HbA1c, and blood glucose levels increased in the filtered water (FW) group but decreased in the EHW group. High-sensitivity CRP increased less in the EHW group. 8-Isoprostane decreased more in the EHW group. In subgroup analysis, the EHW group showed a significantly greater reduction in waist circumference than the FW group only when controlled for high physical activity. Based on the result, we suggest that, among participants in the study who suffered from metabolic syndrome and pre-metabolic syndrome in which the level of active oxygen species is said to be higher than in healthy subjects, the group that consumed EHW and also engaged in a high level of physical activity experienced a suppressed or reduced increase in active oxygen species.

Comparison between the effect of Empagliflozin and Pioglitazone added to metformin in patients with type 2 diabetes and nonalcoholic fatty liver disease

Background/aimsNon-alcoholic fatty liver disease (NAFLD), defined as the accumulation of >5% fat in the liver, is the most frequently co-exist disease with diabetics up to 70%. Current study was conducted to compare efficacy of combination therapy of empagliflozin (EMPA) or pioglitazone (PGZ) with metformin (MET) in patients with T2DM and NAFLD. MethodsIn this open label, prospective clinical trial, sixty patients were randomly assigned to receive EMPA 10 mg/day or PGZ 30 mg/day in combination Metformin (at least 1500 mg) for six months. NAFLD grade and liver stiffness were defined and measured at the beginning and after 6 months. As the secondary outcomes, anthropometric characteristics, lipid profile, plasma glucose test, and liver enzymes test were measured at the baseline and endpoint. ResultsThe results showed that both combination therapy with EMPA+ MET or PGZ+MET significantly reversed fibrosis stage of NAFLD (P<0.05). Significant reduction in lipid profile test, and liver enzymes test were seen in both groups (P<0.05). However, the greater reduction in waist circumference was observed in EMPA groups compared to PGZ (-4.4 ± 2.39 vs -2.05±1.28, p<0.001), meanwhile weight and BMI decreased significantly only in the patients receiving EMPA (-5.78 ± 3.6 kg vs 0.93 ± 0.33 kg and -2.01± 3.19 kg/m2 vs 0.33 ± 0.12 kg/m2, respectively, P<0.001). Conclusioncombination of EMPA or PGZ with metformin equally improved liver fibrosis stage and stiffness in T2DM patients with NAFLD. The improvements of laboratory tests were observed in the both groups, while, regarding weight reduction, only the regimen containing EMPA was effective.

Genetically determined gut microbial abundance and 2-year changes in central adiposity and body composition: The POUNDS lost trial

Growing evidence has linked gut microbiota with regulation of adiposity. We aimed to examine whether the genetically determined relative abundance of gut microbial taxa was associated with long-term changes in adiposity and body composition among individuals who were overweight or obese in weight-loss diet interventions. The study included 692 participants with overweight or obese from the POUNDS Lost trial. We created a genetic risk score (GRS) for the relevant abundance of gut microbial taxa using 20 single nucleotide polymorphisms identified from a recent genome-wide association study. Body composition was assessed using dual-energy X-ray absorptiometry. Higher GRS for the relative abundance of gut microbial taxa was significantly associated with greater reductions in waist circumference, total fat mass (FM), whole-body total percentage of fat mass (FM%), and percentage of trunk fat (TF%) at 2 years (p=0.022, 0.034, 0.023, 0.023, respectively). In addition, dietary protein significantly modified the association between GRS for gut microbial abundance and changes in total FM, FM%, and TF% (p-interactions=0.04, 0.013, and 0.006, respectively) at 6-month, when the maximum weight loss was achieved, even though such interactions were attenuated at 2 years. In the average-protein diet group, a higher microbial abundance GRS was associated with greater reductions in total FM (p=0.007), FM% (p=0.002), and TF% (p<0.001) at 6 months, while no associations were found in the high-protein diet group (p>0.05). Our results suggest that the higher genetically determined relative abundance of gut microbial taxa may be related to long-term improvement of whole-body and central fatness and body composition in response to low-calorie diet interventions.

Weight loss therapy in obese hypertensive patients: the effect of orlistat versus metformin

Abstract Purpose Obesity is independently associated with blood pressure (BP) and weight loss is recommended for BP reduction in overweight hypertensive individuals. However, the challenge remains to find an appropriate approach for weight reduction to influence BP status. The aim was to evaluate the effects of orlistat (O) and metformin (M) on BP and metabolic homeostasis in obese hypertensive patients (P). Methods 106 P (mean body mass index (BMI) 34.2 kg/m2, waist circumference (WC) 104 cm) were included in the study. All followed a diet (D) for 3 month, after that 52 P started on M (1000 mg/day) and 52 on O treatment (360 mg/day) for 6 month. Anthropometry, metabolic profile, including lipids and oral glucose tolerance test with insulin, uric acid, serum creatinine, calculated GFR were performed at baseline and after 3, 6, 9 months. Homeostatic model assessment HOMA-R was calculated for insulin resistance. At baseline and after 9 months P underwent clinic and 24-hour BP measurements. Results At baseline was an excellent correlation between BMI and HOMA-R (r=0.45, P&amp;lt;.01), BMI and uric acid (r=0.31, P&amp;lt;.05). Also asymptomatic hyperuricemia was observed in 24.9%, dyslipidemia in 43.1%, impaired glucose tolerance in the 21% and chronic kidney disease in 9.0% P. 29% of the P had &amp;gt;3 metabolic syndrome components. There was no significant reduction in BMI (−0.9±0.1 kg/m2) and BP after 3 month of D in the whole group. The reduction of BMI was significant in both groups after 6 months of pharmacological treatment (P&amp;lt;0.01 for O and P &amp;lt;0.05 for M) but was significantly greater in group O than in group M (−0.61±0.3 versus −0.32±0.2 kg/m2, P&amp;lt;.01). Treatment with O produced a 4.16% reduction in weight (101.0±8.0 vs. 95.3±7.1 kg, P&amp;lt;.01) and this reduction was more significant than the reduction produced by M (4.69 vs. 2.42%, P&amp;lt;.01). There were also greater reductions in WC with O therapy compared to M (P &amp;lt;.05). We also found a slight, though not significant, improvement in HOMA-R in both groups. BP decreased more in O than in M (SBP −6.7±7.1 vs. −3.2±5.7 mmHg and DBP −6.4±6.2 vs. −2.2±8.1 mmHg, P&amp;lt;.01 for both). The O group had significantly greater reductions in total cholesterol and low-density lipoprotein cholesterol (P&amp;lt;.01 for both). Moreover, we found significant reduction of serum uric acid level after O therapy in comparison with M (P&amp;lt;.01). Conclusions 29% of the obese hypertensive patients had &amp;gt;3 metabolic syndrome components. Abdominal obesity was the most common, followed by dyslipidemia, asymptomatic hyperuricemia and impaired glucose tolerance. Lifestyle program with diet alone wasn't enough for a reduction in weight and BP. Weight-loss program with orlistat is more effective than with metformin and leads to better BP control in obese hypertensive individuals. The weight reduction by O is associated with lipid-lowering effect and reduction of serum uric acid level, what can result in the reduction of cardiovascular risk. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): National Medical University

Genetically Determined Gut Microbiome Abundance and 2-Year Changes in Central Adiposity and Body Composition: The POUNDS Lost Trial

ObjectivesGrowing evidence has linked gut microbiome abundance with adiposity regulation. A recent genome-wide association study (GWAS) identified 20 genetic variants related to gut microbiome abundance. We aimed to examine whether the genetically determined gut microbiome abundance was associated with 2-year changes in adiposity and body composition among overweight and obese individuals in weight-loss diet interventions. MethodsThe study included 692 overweight and obese participants from Preventing Overweight Using Novel Dietary Strategies trial (POUNDS Lost). We created a genetic risk score (GRS) for gut microbiome abundance using 20 single nucleotide polymorphisms identified from the most recent GWAS. A higher GRS indicates a higher gut microbiome abundance. Body composition was assessed using dual-energy X-ray absorptiometry (DXA). ResultsWe found that the gut microbiome abundance GRS was significantly associated with waist circumference and body composition during a 2-year diet intervention. Participants with a higher genetically determined gut microbiome abundance had a greater reduction in waist circumference, whole body total fat %, and trunk fat %, and greater increase in lean mass % at 2 years, after adjustment for age, race, sex, body mass index, diet intervention, and baseline values of respective outcome traits (P < 0.05 for all). Least square means comparing the extreme tertiles (T3 vs. T1) were –6.6 vs. –4.4 cm for waist circumference, –3.0 vs. –1.4 for whole-body fat %, 3.0 vs. 1.4 for lean mass %, and –3.9 vs. –1.8 for trunk fat %, respectively. ConclusionsThe higher genetically determined gut microbiome abundance is related to long-term improvement of whole-body and central fatness, as well as lean body mass in response to low-calorie diet interventions. Funding SourcesThe study was supported by grants from the National Heart, Lung, and Blood Institute (HL071981, HL034594, HL126024), the National Institute of Diabetes and Digestive and Kidney Diseases (DK115679, DK091718, DK100383), the Fogarty International Center (TW010790), and Tulane Research Centers of Excellence Awards. Xiang Li was the recipient of the American Heart Association Predoctoral Fellowship Award (19PRE34380036).

Diabetes drug is effective for weight control, study shows

New data support the use of once-weekly S.C. semaglutide plus lifestyle intervention for weight control in patients who are overweight or obese. In a recent clinical trial, patients given semaglutide 2.4 mg weekly lost an average of 15% of their body weight over a 16-month period compared with a 2.4% loss for those given placebo. Novo Nordisk filed a new drug application with FDA in December 2020 seeking approval for use of semaglutide for weight management. “This is by far the most effective intervention we have seen for weight management when you compare it to many of the currently existing drugs,” said corresponding author Robert Kushner, MD, professor of medicine and medical education at Northwestern University Feinberg School of Medicine, in a press release. “Semaglutide sets the bar for a new generation of more-effective weight loss medications.” The STEP 1 trial—Semaglutide Treatment Effect in People with Obesity—randomized 1,961 adult patients without diabetes who had a BMI of 30 or greater, or a BMI of 27 or greater plus one or more weight-related coexisting conditions, to 68 weeks of treatment with once-weekly S.C. semaglutide 2.4 mg (1,306 participants) or placebo (655 participants) plus lifestyle interventions. The completion rate of the trial was high, with 94.3% of patients finishing the 68 weeks. The results, published March 18, 2021, in the New England Journal of Medicine, showed that patients treated with semaglutide had an estimated mean weight change of −14.9% at week 68 compared with −2.4% of patients receiving placebo (P < 0.001). Other benefits included greater reductions in waist circumference and systolic and diastolic blood pressure, as well as changes in A1C, fasting plasma glucose, C-reactive protein, and fasting lipid levels. Both groups reported adverse events at similar percentages—89.7% (semaglutide group) and 86.4% (placebo group). However, more patients in the semaglutide group experienced GI adverse events such as nausea, diarrhea, vomiting, and constipation. These adverse events were mild to moderate, transient, and generally resolved without permanent discontinuation of the regimen. The results observed with semaglutide add to the available data for liraglutide (Saxenda—Novo Nordisk), another glucagon-like peptide-1 (GLP-1) receptor agonist, which is FDA approved for chronic weight management in patients who are overweight or obese. Liraglutide is given once daily as an S.C. injection, and data have shown that the majority of patients treated with this agent experience a 5% or greater reduction in weight loss. Although liraglutide is effective, the need to administer it as a daily injection may be a limiting factor for more widespread use. Along with the GLP-1 agonists, the sodium–glucose cotransporter-2 (SGLT-2) inhibitors have also been effective for weight loss during trials evaluating their use for management of type 2 diabetes. The ability of this class of medications to reduce body weight is moderate, however, because of counter-regulatory mechanisms that work to maintain body weight. Further analyses will evaluate the use of SGLT-2 inhibitors in combination with other agents such as the GLP-1 agonists as a potential weight management strategy. Obesity is a global health challenge that increases the risk for numerous comorbidities and even death. Therefore, effective interventions aimed at helping patients lose weight and keep it off long term are needed. Medications such as phentermine/topiramate (Qsymia—Vivus), naltrexone/bupropion (Contrave—Currax), and orlistat (Alli—GlaxoSmithKline; available OTC) have all been used for weight control, but the results have not been as robust as those observed for semaglutide in the STEP 1 trial. Even so, there is still the need for longer-term data to determine the sustainability of semaglutide for weight loss. Clinicians and patients will also need to consider the drug's delivery as a weekly S.C. injection, how GI adverse events can be managed, and cost implications. Lifestyle modification is the cornerstone of treatment for management of patients who are overweight and obese. Pharmacists can counsel patients on proper nutrition and the need for increased physical activity and inform those who select pharmacotherapy that several treatment options are available. They can also educate patients on the risks and benefits of each treatment option and encourage them throughout their weight loss journey.

Optimising weight-loss interventions in cancer patients-A systematic review and network meta-analysis.

BackgroundExcess weight has been associated with increased morbidity and a worse prognosis in adult patients with early-stage cancer. The optimal lifestyle interventions to optimize anthropometric measures amongst cancer patients and survivors remain inconsistent.ObjectiveTo conduct a systematic review and network meta-analysis (NMA) of randomized controlled trials (RCTs) comparing the effects of exercise and dietary interventions alone or in combination on anthropometric measures of adult cancer patients and survivors.MethodsA systematic search of Medline, Embase and the Cochrane Trials Registry was performed. Outcomes of interest included changes in weight, body mass index (BMI), and waist circumference. Screening and data collection were performed by two reviewers. Bayesian NMAs were performed.ResultsOverall, 98 RCTs were included; 75 were incorporated in NMAs (n = 12,199). Groups of intervention strategies included: 3 exercise interventions, 8 dietary interventions, 7 combination interventions of diet and exercise and standard care. Median intervention duration was 26 weeks. NMA suggested that diet alone (mean difference [MD] -2.25kg, 95% CrI -3.43 to -0.91kg) and combination strategies (MD -2.52kg, 95% CrI -3.54 to -1.62kg) were associated with more weight loss compared to standard care. All dietary interventions achieved a similar magnitude of weight loss (MD range from -2.03kg to -2.52kg). Both diet alone and combination strategies demonstrated greater BMI reductions versus standard care, and each of diet alone, exercise alone and combination strategies demonstrated greater reductions in waist circumference than standard care.ConclusionDiet and exercise alone or in combination are effective lifestyle interventions to improve anthropometric measures in cancer patients and survivors. All reputable diets appear to be similarly effective to achieve weight loss.

Review of key findings from the OPTIWIN trial: Implications and future directions for medical weight management using total diet replacement

Over the past century, obesity and obesity-related comorbidities have become one of the greatest public health threats, and rates of morbidity and mortality continue to grow at alarming rates across the globe. Even modest amounts of weight loss from baseline can lead to significant improvements in quality of life, physical functioning, and remission of co-morbid conditions. Interventions to reduce excess weight vary from nutrition and surgical interventions, to pharmacotherapy, to lifestyle behavioral therapy. Findings related to the efficacy of various lifestyle behavioral interventions for the treatment of obesity continue to be mixed. The purpose of this article is to review key findings from the OPTIWIN obesity treatment trial, which tested the long-term effectiveness of a total meal replacement dietary intervention compared to a gold standard food-based lifestyle behavioral treatment for obesity. Overall, participants in the total meal replacement group lost significantly more excess weight and total fat mass, and demonstrated greater reductions in waist circumference during the active weight loss phase (baseline to 26 weeks), compared to the food-based group. These differences were maintained during the maintenance phase (26-52 weeks). The food-based group also had a higher proportion of non-responders (e.g., failure to lose ≥ 3% of their initial body weight) than the meal replacement group at 26 and 52 weeks. Implications for findings and future directions for medical weight management using lifestyle interventions and meal replacement methods are also discussed.

The effect of green Mediterranean diet on cardiometabolic risk; a randomised controlled trial

BackgroundA Mediterranean diet is favourable for cardiometabolic risk.ObjectiveTo examine the residual effect of a green Mediterranean diet, further enriched with green plant-based foods and lower meat intake, on cardiometabolic risk.MethodsFor...

Differential effects of a school-based obesity prevention program: A cluster randomized trial.

School‐based healthy living interventions are widely promoted as strategies for preventing obesity. The peer‐led Healthy Buddies™ curriculum has been shown to improve obesity‐related outcomes in school‐aged children. We examined whether these improvements existed among subgroups of children stratified by sex, income level and urban/rural geography. In a cluster‐randomized controlled trial, elementary schools in Manitoba, Canada, were randomly allocated to Healthy Buddies™ (10 schools, 340 students) or standard curriculum (10 schools, 347 students). Healthy Buddies™ participants had 21weekly lessons on healthy eating, physical activity and self‐efficacy, delivered by children age 9–12 to children age 6–8. We assessed pre‐ and post‐intervention body mass index (BMI) z‐scores, waist circumference, healthy living knowledge, dietary intake and self‐efficacy among the younger children. Compared to standard curriculum (n = 154), Healthy Buddies™ participants (n = 157) experienced a greater reduction in waist circumference (−1.7 cm; 95% confidence interval [CI][−2.8, −0.5 cm]) and improved dietary intake (4.6; 95% CI [0.9, 8.3]), healthy living knowledge (5.9; 95% CI [2.3, 9.5]) and self‐efficacy (5.3; 95% CI [1.0, 9.5]) scores. In subgroup analyses, effects for waist circumference (−2.0 cm; 95% CI [−3.6, −0.5]), healthy living knowledge (9.1; 95% CI [4.4, 13.8]) and self‐efficacy (8.3; 95% CI [3.3, 13.3]) were significant among boys. Dietary intake (10.5; 95% CI [5.5, 15.4]), healthy living knowledge (9.8; 95% CI [4.5, 15.0]) and self‐efficacy (6.7; 95% CI [0.7, 12.7]) improved among urban‐dwelling but not rural‐dwelling children. Healthy Buddies™ was effective for boys and children living in urban settings. Enhanced curricula may be needed to improve program effectiveness for select subgroups of school‐aged children.

Impact of a multidisciplinary intervention on physical fitness, physical activity habits and the association between aerobic fitness and components of metabolic syndrome in adults diagnosed with metabolic syndrome

BackgroundMetabolic syndrome (MetS) is a health disorder characterized by metabolic abnormalities that predict an increased risk to develop cardiovascular disease (CVD) and type 2 diabetes (T2DM). It can be resolved, and its complications reduced, by lifestyle interventions offered in primary care. The objectives of this study were to evaluate the impact of the exercise program of the CHANGE feasibility study on physical fitness and physical activity habits, and assess associations between changes in MetS components and cardiorespiratory fitness (CRF).MethodsIn this analysis of 192 of the 293 adults with MetS in the overall study, the impact on physical fitness [aerobic capacity, muscular fitness and flexibility], and non-supervised physical activities was investigated over 12 months. In the CHANGE program, aerobic capacity, muscular fitness and flexibility were assessed at baseline, after 3 months of weekly supervised exercise, and following 9 additional months during which participants had one monthly session of supervised exercise. Additionally, CRF response was also examined in relation to changes in MetS components [fasting glucose, high-density lipoprotein (HDL) cholesterol, triglycerides, blood pressure, waist circumference (WC)].ResultsFitness variables were significantly increased at 12 months with most of the improvements reached by 3 months (estimated VO2 max: 6 and 12%; partial curl-ups: 55 and 80%; push-ups: 50 and 100%; flexibility: 22 and 10% in men and women, respectively, p < 0.001). As expected, the duration and intensity of supervised aerobic physical activity increased during the first 3 months of supervision in both men and women, and remained unchanged for the duration of the program. The duration of non-supervised physical activities did not change during the program in men whereas an increase in manual work of moderate intensity was recorded in women between 3 and 12 months. In women, mean changes in WC were significantly greater among high VO2 max responders than low responders, between 0 and 12 months, as well as between 3 and 12 months (− 3.42 cm and − 4.32 cm, respectively, p < 0.05). No associations were seen with MetS components in men. Higher intensity activities were maintained by both sexes at one year.ConclusionPatients with MetS participating in the CHANGE lifestyle program improved physical fitness and physical activity habits by three months and maintained these gains over one year. Women who achieved a greater VO2 max increase had greater reductions in WC compared to low VO2max responders.

Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study.

Weight gain is common among breast cancer patients and may contribute to poorer treatment outcomes. Most programs target breast cancer survivors after the completion of therapy and focus on weight reduction. This study examined the feasibility and preliminary efficacy of an intervention designed to prevent primary weight gain among women receiving neoadjuvant chemotherapy for breast cancer. Thirty-eight newly diagnosed stage II or III breast cancer patients were randomized to the BALANCE intervention or usual care within 3weeks of starting neoadjuvant chemotherapy. The intervention used a size acceptance-based approach and encouraged home-based resistance and moderate-intensity aerobic exercise as well as a low energy-dense diet to prevent weight gain. Assessments were conducted at baseline, mid-chemotherapy (3months), and post-chemotherapy (6months). Intervention feasibility, acceptability, and preliminary effects on anthropometric, quality of life, and circulating biomarker measures were evaluated. Intervention participant retention (100%) and in-person session attendance (80%) were high during the intervention period, although attendance dropped to 43% for telephone-delivered sessions. The majority of participants reported being satisfied with the intervention during chemotherapy (88%). Participants in the intervention group had greater reductions in waist circumference (p = .03) and greater improvements in self-reported vitality scores (p = .03) than the control group at the end of chemotherapy. Significant effects on biomarkers were not observed. A size acceptance weight management program is feasible during neoadjuvant chemotherapy among breast cancer patients and may have beneficial effects on waist circumference and patient vitality. This study was registered as a clinical trial at www.clinicaltrials.gov (NCT00533338).

Cost-Effectiveness of a Weight Loss Intervention: An Adaptation of the Look AHEAD Lifestyle Intervention in the US Military.

This study aimed to assess whether a counselor-initiated (CI) adaptation of the Look AHEAD (Action for Health in Diabetes) intensive lifestyle intervention in a military setting was cost-effective relative to a self-paced (SP) adaptation. A cost-effectiveness analysis from a payer perspective was performedalongside a 2014-2017 randomized behavioral weight loss trial among 248 active-duty military personnel stationed at a US Air Force base in Texas. Incremental cost-effectiveness ratios were calculated for weight loss, reductions in waist circumference, and quality-adjusted life-years (QALYs). After 12 months, the CI adaptation cost more per participant compared with the SP adaptation ($1,081 vs. $120) but achieved greater weight loss (1.86 kg vs. 0.06 kg), greater reductions in waist circumference (1.85 cm vs. 0.48 cm), and more QALYs (0.871 vs. 0.856). The incremental cost-effectiveness ratio for the CI adaptation relative to the SP adaptation was $61,268 per additional QALY. At willingness-to-pay thresholds of $50,000 and $100,000 per QALY, the CI adaptation was 45% and 49% likely to be cost-effective, respectively. The CI delivery of the Look AHEAD Intensive Lifestyle Intervention may offer a cost-effective approach to tackle excess weight in the US military.

Effect of increased calcium consumption from fat-free milk in an energy-restricted diet on the metabolic syndrome and cardiometabolic outcomes in adults with type 2 diabetes mellitus: a randomised cross-over clinical trial.

We investigated the effects of high-Ca fat-free milk phase (MD) (prescription of approximately 1500 mg of Ca/d) v. low-Ca phase (CD) (prescription of approximately 800 mg of Ca/d) in an energy-restricted diet on the metabolic syndrome (MetS) and cardiometabolic measures in individuals with type 2 diabetes mellitus (T2DM) and low habitual Ca consumption (<600 mg/d). In this randomised cross-over design, fourteen adults with T2DM (49·5 (sd 8·6) years, BMI 29·4 (sd 4·5) kg/m2) consumed either MD or CD for 12 weeks, with a washout of 18 weeks between phases. A breakfast shake containing 700 mg (MD) or 6·4 mg (CD) of Ca was consumed in the laboratory. In addition, energy-restricted diets were prescribed (800 mg of dietary Ca/d). Waist circumference (WC), fasting glucose, fasting TAG, systolic (SBP) and diastolic blood pressure (DBP), fasting total cholesterol, fasting LDL-cholesterol, fasting HDL-cholesterol, HDL:LDL ratio, HDL:TAG ratio and lipid accumulation product (LAP) index were assessed at baseline and after each phase. Ca consumption during the study was equivalent to 1200 mg/d during MD and 525 mg/d during CD. There was a greater reduction in WC, SBP, DBP and LAP index after MD compared with CD. HDL:LDL ratio increased and total cholesterol, LDL-cholesterol, SBP, DBP and LAP index decreased only in MD. The consumption of approximately 1200 mg of Ca/d (700 mg from fat-free milk+500mg from other dietary sources) associated with an energy-restricted diet decreased some of the MetS components and cardiometabolic measures in adults with T2DM.

Randomised control trial of the effectiveness of an integrated psychosocial health promotion intervention aimed at improving health and reducing substance use in established psychosis (IMPaCT)

BackgroundPeople with psychosis have a reduced life expectancy of 10–20 years, largely due to cardiovascular disease. This trial aimed to determine the effectiveness of a modular health promotion intervention (IMPaCT Therapy) in improving health and reducing cardiovascular risk in psychosis.MethodsA multicentre, two arm, parallel cluster RCT was conducted across five UK mental health NHS trusts. Community care coordinators (CC) were randomly assigned to training and supervision in delivering IMPaCT Therapy or treatment as usual (TAU) to current patients with psychosis (cluster). The primary outcome was the physical and mental health subscales of the Short form-36 (SF-36) questionnaire.ResultsOf 104 care coordinators recruited, 52 (with 213 patients) were randomised to deliver IMPaCT therapy and 52 (with 193 patients) randomised to TAU. Of 406 patients, 318 (78%) and 301 (74%) attended 12- and 15-month follow-up respectively. IMPaCT therapy showed no significant effect on the physical or mental health component SF-36 scores versus TAU at 12 or 15 months. No effect was observed for cardiovascular risk indicators, except for HDL cholesterol, which improved more with IMPACT therapy than TAU (Treatment effect (95% CI); 0.085 (0.007 to 0.16); p = 0.034). The 22% of patients who received >180 min of IMPACT Therapy in addition to usual care achieved a greater reduction in waist circumference than did controls, which was clinically significant.ConclusionTraining and supervising community care coordinators to use IMPaCT therapy in patients with psychosis is insufficient to significantly improve physical or mental health quality of life. The search for effective, pragmatic interventions deliverable in health care services continues.Trial registrationThe trial was retrospectively registered with ISRCTN registry on 23/4/2010 at ISRCTN58667926; recruitment started on 01/03/2010 with first randomization on 09.08.2010 ISRCTN58667926.

PREVENT-DM Comparative Effectiveness Trial of Lifestyle Intervention and Metformin.

Although the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions (ILI) and metformin to prevent type 2 diabetes, no studies have tested their comparative effects in pragmatic settings. This study was designed to compare the real-world effectiveness of ILI, metformin, and standard care among Hispanic women (Latinas) with prediabetes. RCT. Ninety-two Latinas, who had a mean hemoglobin A1c of 5.9%, BMI of 33.3 kg/m2, and waist circumference of 97.4 cm (38.3 inches), were recruited from an urban community and randomly assigned to ILI, metformin, or standard care using 1:1:1 allocation. Data were collected from 2013-2015 and analyzed in 2016. The 12-month ILI was adapted from the Diabetes Prevention Program's ILI and delivered by community health workers (promotoras) over 24 sessions. Metformin participants received 850 mg twice daily. Those randomized to standard care continued their regular medical care. Weight and secondary outcomes (waist circumference, blood pressure, hemoglobin A1c, fasting plasma glucose, insulin, and lipids) were assessed at baseline and 12 months. ILI participants demonstrated significantly greater mean weight loss (-4.0 kg, 5.0%) than metformin (-0.9 kg, 1.1%) and standard care participants (+0.8 kg, 0.9%) (p<0.001). The difference in weight loss between metformin and standard care was not significant. The ILI group experienced a greater reduction in waist circumference than standard care (p=0.001), and a marginal improvement in hemoglobin A1c compared with metformin and standard care (p=0.063). In the first comparative effectiveness trial of diabetes prevention treatments, a 12-month ILI produced significantly greater weight loss than metformin and standard care among Latinas with prediabetes. These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group, which may be superior to metformin. Future pragmatic trials involving larger samples should examine differences in diabetes incidence associated with these treatments.

Salba-chia (Salvia hispanica L.) in the treatment of overweight and obese patients with type 2 diabetes: A double-blind randomized controlled trial

Background and AimPreliminary findings indicate that consumption of Salba-chia (Salvia hispanica L.), an ancient seed, improves management of type 2 diabetes and suppresses appetite. The aim of this study was to assesse the effect of Salba-chia on body weight, visceral obesity and obesity-related risk factors in overweight and obese adults with type 2 diabetes. MethodsA double-blind, randomized, controlled trial with two parallel groups involved 77 overweight or obese patients with type 2 diabetes (HbA1c: 6.5–8.0%; BMI: 25–40 kg/m2). Both groups followed a 6-month calorie-restricted diet; one group received 30 g/1000 kcal/day of Salba-chia, the other 36 g/1000 kcal/day of an oat bran-based control. Primary endpoint was change in body weight over 6-months. Secondary endpoints included changes in waist circumference, body composition, glycemic control, C-reactive protein, and obesity-related satiety hormones. ResultsAt 6-months, participants on Salba-chia had lost more weight than those on control (1.9 ± 0.5 kg and 0.3 ± 0.4 kg, respectively; P = 0.020), accompanied by a greater reduction in waist circumference (3.5 ± 0.7 cm and 1.1 ± 0.7 cm, respectively; P = 0.027). C-reactive protein was reduced by 1.1 ± 0.5 mg/L (39 ± 17%) on Salba-chia, compared to 0.2 ± 0.4 mg/L (7 ± 20%) on control (P = 0.045). Plasma adiponectin on the test intervention increased by 6.5 ± 0.7%, with no change observed on control (P = 0.022). ConclusionsThe results of this study, support the beneficial role of Salba-chia seeds in promoting weight loss and improvements of obesity related risk factors, while maintaining good glycemic control. Supplementation of Salba-chia may be a useful dietary addition to conventional therapy in the management of obesity in diabetes. Registrationclinicaltrials.gov identifier: NCT01403571.

Randomized controlled trial of a nationally available weight control program tailored for adults with type 2 diabetes.

Modest weight loss from clinical interventions improves glycemic control in type 2 diabetes (T2DM). Data are sparse on the effects of weight loss via commercial weight loss programs. This study examined the effects on glycemic control and weight loss of the standard Weight Watchers program, combined with telephone and email consultations with a certified diabetes educator (WW), compared with standard diabetes nutrition counseling and education (standard care, SC). In a 12-month randomized controlled trial at 16 U.S. research centers, 563 adults with T2DM (HbA1c 7-11%; BMI 27-50 kg/m2 ) were assigned to either the commercially available WW program (regular community meetings, online tools), plus telephone and email counseling from a certified diabetes educator, or to SC (initial in-person diabetes nutrition counseling/education, with follow-up informational materials). Follow-up rate was 86%. Twelve-month HbA1c changes for WW and SC were -0.32 and +0.16, respectively; 24% of WW versus 14% of SC achieved HbA1c <7.0% (P = 0.004). Weight losses were -4.0% for WW and -1.9% for SC (Ps < 0.001). 26% of WW versus 12% of SC reduced diabetes medications (P < 0.001). WW participants had greater reductions in waist circumference (P < 0.001) and C-reactive protein (P = 0.02) but did not differ on other cardiovascular risk factors. Widely available commercial weight loss programs with community and online components, combined with scalable complementary diabetes education, may represent accessible and effective components of management plans for adults with overweight/obesity and T2DM.

Cost-effectiveness of SHINE: A Telephone Translation of the Diabetes Prevention Program.

BACKGROUNDThe Support, Health Information, Nutrition, and Exercise (SHINE) trial recently showed that a telephone adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention was effective in reducing weight among patients with metabolic syndrome. The aim of this study is to determine whether a conference call (CC) adaptation was cost effective relative to an individual call (IC) adaptation of the DPP lifestyle intervention in the primary care setting.METHODSWe performed a stochastic cost-effectiveness analysis alongside a clinical trial comparing two telephone adaptations of the DPP lifestyle intervention. The primary outcomes were incremental cost-effectiveness ratios estimated for weight loss, body mass index (BMI), waist circumference, and quality-adjusted life years (QALYs). Costs were estimated from the perspective of society and included direct medical costs, indirect costs, and intervention costs.RESULTSAfter one year, participants receiving the CC intervention accumulated fewer costs ($2,831 vs. $2,933) than the IC group, lost more weight (6.2 kg vs. 5.1 kg), had greater reduction in BMI (2.1 vs. 1.9), and had greater reduction in waist circumference (6.5 cm vs. 5.9 cm). However, participants in the CC group had fewer QALYs than those in the IC group (0.635 vs. 0.646). The incremental cost-effectiveness ratio for CC vs. IC was $9,250/QALY, with a 48% probability of being cost-effective at a willingness-to-pay of $100,000/QALY.CONCLUSIONSCC delivery of the DPP was cost effective relative to IC delivery in the first year in terms of cost per clinical measure (weight lost, BMI, and waist circumference) but not in terms of cost per QALY, most likely because of the short time horizon.

Prospective associations between sedentary time, physical activity, fitness and cardiometabolic risk factors in people with type 2 diabetes

Aims/hypothesisThe aim of this study was to examine the prospective associations between objectively measured physical activity energy expenditure (PAEE), sedentary time, moderate-to-vigorous-intensity physical activity (MVPA), cardiorespiratory fitness (CRF) and cardiometabolic risk factors over 4 years in individuals with recently diagnosed diabetes.MethodsAmong 308 adults (mean age 61.0 [SD 7.2] years; 34% female) with type 2 diabetes from the Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care (ADDITION)-Plus study, we measured physical activity using individually calibrated combined heart rate and movement sensing. Multivariable linear regression models were constructed to examine the associations between baseline PAEE, sedentary time, MVPA, CRF and cardiometabolic risk factors and clustered cardiometabolic risk (CCMR) at follow-up, and change in these exposures and change in CCMR and its components over 4 years of follow-up.ResultsIndividuals who increased their PAEE between baseline and follow-up had a greater reduction in waist circumference (−2.84 cm, 95% CI −4.84, −0.85) and CCMR (−0.17, 95% CI −0.29, −0.04) compared with those who decreased their PAEE. Compared with individuals who decreased their sedentary time, those who increased their sedentary time had a greater increase in waist circumference (3.20 cm, 95% CI 0.84, 5.56). Increases in MVPA were associated with reductions in systolic blood pressure (−6.30 mmHg, 95% CI −11.58, −1.03), while increases in CRF were associated with reductions in CCMR (−0.23, 95% CI −0.40,−0.05) and waist circumference (−3.79 cm, 95% CI −6.62, −0.96). Baseline measures were generally not predictive of cardiometabolic risk at follow-up.Conclusions/interpretationEncouraging people with recently diagnosed diabetes to increase their physical activity and decrease their sedentary time may have beneficial effects on their waist circumference, blood pressure and CCMR.