Greater Weight Reduction Research Articles

Impact of Disease Duration on the Effects of Pramlintide in Type 1 Diabetes: A Post Hoc Analysis of Three Clinical Trials

IntroductionAdjunctive mealtime use of the amylin analog pramlintide improves postprandial hyperglycemia in patients with type 1 diabetes. This post hoc analysis of three randomized trials evaluated whether disease duration affected responses to pramlintide.MethodsPatients received mealtime pramlintide 30 or 60 µg (n = 714) or placebo (n = 537) as an adjunct to insulin and were stratified into tertiles by diabetes duration at baseline. Efficacy and safety end points were assessed at week 26 using analysis of covariance and logistic regression models.ResultsDisease durations for tertiles 1, 2, and 3 were 6.7, 16.5, and 29.9 years, respectively. In all tertiles, pramlintide resulted in greater reductions in glycated hemoglobin (HbA1c) and weight than placebo, with greater weight reductions and insulin sparing in tertiles 2 and 3. Insulin dose and weight increased in the placebo group in all tertiles. Baseline HbA1c was a predictor of HbA1c lowering in both treatment groups (P < 0.0001); higher daily insulin predicted a smaller percent increase in insulin dose for placebo (P = 0.01); and higher body weight predicted greater weight loss in both pramlintide- and placebo-treated patients (P < 0.05). Event rates for severe hypoglycemia were similar for pramlintide and placebo and increased with longer duration of diabetes for both groups. Nausea with pramlintide increased with longer disease duration.ConclusionMealtime pramlintide resulted in greater reductions in HbA1c than placebo, regardless of diabetes duration at baseline. Longer disease duration appeared to augment insulin sparing and weight loss with pramlintide, with a potential for increased incidence of hypoglycemia and nausea.FundingThe design and conduct of the study were supported by Amylin Pharmaceuticals, San Diego, CA, USA.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0326-5) contains supplementary material, which is available to authorized users.

Abstract 14759: Aggressive Risk factor REduction STudy: Implications for the Substrate for Atrial Fibrillation (ARREST-AF Substrate Study)

Introduction: Cardiac risk factors (RF) such as hypertension, diabetes mellitus, obesity and sleep apnoea have been associated with structural and electrical remodeling of the atria that forms the substrate leading to the development and progression of atrial fibrillation (AF). We evaluated the impact of aggressive management of RFs on the AF substrate. Methods: 50 consecutive AF pts with BMI ≥ 27 kg/m2 and ≥1 cardiac risk factor were randomized to either RF management (RFM) or usual care (Control). The RFM group were managed in a physician-led clinic directed at RF control in accordance with AHA/ACC guidelines. Both the groups were studied with electrophysiological (EP) study, echocardiography, cardiac MRI, serum fibrosis and endothelial function markers at baseline and repeated at &gt; 6 mths later. Subjects in RFM group had &gt;10% weight loss at repeat study. Results: There were no differences in baseline characteristics or follow-up duration (15±3 mths) between the groups (p=NS). RFM resulted in greater reduction in weight (p&lt;0.001), systolic blood pressure (p=0.004), better glycaemic control (p=0.003) and lipid profile (p=0.04), reduced LA size (p=0.003) and total pericardial fat volume (p=0.001). The table presents the data showing that RFM resulted in marked reversal in atrial electrical parameters, reduced pro-inflammatory/fibrotic markers and improved endothelial/platelet function. Conclusion: Aggressive risk factor management reverses electrical and structural remodeling and results in a significant improvement in endothelial and platelet function underscoring its importance in AF management. (Trial registration: ACTRN12613000444785)

Effects of total fat intake on body weight.

In order to prevent overweight and obesity in the general population we need to understand the relationship between the proportion of energy from fat and resulting weight and body fatness in the general population. To assess the effects of proportion of energy intake from fat on measures of weight and body fatness (including obesity, waist circumference and body mass index) in people not aiming to lose weight, using all appropriate randomised controlled trials (RCTs) and cohort studies in adults, children and young people We searched CENTRAL to March 2014 and MEDLINE, EMBASE and CINAHL to November 2014. We did not limit the search by language. We also checked the references of relevant reviews. Trials fulfilled the following criteria: 1) randomised intervention trial, 2) included children (aged ≥ 24 months), young people or adults, 3) randomised to a lower fat versus usual or moderate fat diet, without the intention to reduce weight in any participants, 4) not multifactorial and 5) assessed a measure of weight or body fatness after at least six months. We also included cohort studies in children, young people and adults that assessed the proportion of energy from fat at baseline and assessed the relationship with body weight or fatness after at least one year. We duplicated inclusion decisions and resolved disagreement by discussion or referral to a third party. We extracted data on the population, intervention, control and outcome measures in duplicate. We extracted measures of weight and body fatness independently in duplicate at all available time points. We performed random-effects meta-analyses, meta-regression, subgrouping, sensitivity and funnel plot analyses. We included 32 RCTs (approximately 54,000 participants) and 30 sets of analyses of 25 cohorts. There is consistent evidence from RCTs in adults of a small weight-reducing effect of eating a smaller proportion of energy from fat; this was seen in almost all included studies and was highly resistant to sensitivity analyses. The effect of eating less fat (compared with usual diet) is a mean weight reduction of 1.5 kg (95% confidence interval (CI) -2.0 to -1.1 kg), but greater weight loss results from greater fat reductions. The size of the effect on weight does not alter over time and is mirrored by reductions in body mass index (BMI) (-0.5 kg/m(2), 95% CI -0.7 to -0.3) and waist circumference (-0.3 cm, 95% CI -0.6 to -0.02). Included cohort studies in children and adults most often do not suggest any relationship between total fat intake and later measures of weight, body fatness or change in body fatness. However, there was a suggestion that lower fat intake was associated with smaller increases in weight in middle-aged but not elderly adults, and in change in BMI in the highest validity child cohort. Trials where participants were randomised to a lower fat intake versus usual or moderate fat intake, but with no intention to reduce weight, showed a consistent, stable but small effect of low fat intake on body fatness: slightly lower weight, BMI and waist circumference compared with controls. Greater fat reduction and lower baseline fat intake were both associated with greater reductions in weight. This effect of reducing total fat was not consistently reflected in cohort studies assessing the relationship between total fat intake and later measures of body fatness or change in body fatness in studies of children, young people or adults.

Health-Related Quality of Life after Bariatric Surgery and its Correlation with Glycaemic Status in Hong Kong Chinese Adults.

To evaluate health-related quality of life (HRQOL) following bariatric surgery and its correlation with different glycaemic status in Hong Kong Chinese adults. In 2002-2008, obese Chinese adults were recruited for bariatric surgery, undergoing laparoscopic adjustable gastric banding or laparoscopic sleeve gastrectomy. Patients were invited to complete the Chinese Hong Kong Medical Outcomes Study Short-Form Health Survey (SF-36) at baseline and at 1-year post operation. Sixty patients (60 % female) completed baseline and 1-year follow-up HRQOL assessments. Mean age was 38 years and mean BMI was 41.6 kg/m(2). At baseline, 30.0 % of patients had diabetes and 31.7 % prediabetes. Mean absolute weight reduction 1 year after bariatric surgery was 19.8 kg. Statistically significant improvements in SF-36 scores were demonstrated in all physical domains and in three of the four psychological domains. Greater body weight reduction was associated with greater improvements in certain physical domains postoperatively. After adjusting for co-variables, abnormal glucose tolerance was associated with greater improvements in five of the eight HRQOL domains. Bariatric surgery resulted in significant gains in HRQOL as well as significant reductions in body weight in obese Chinese adults. This study suggests that bariatric surgery offers greater HRQOL improvements in patients with prediabetes and diabetes compared with normoglycaemic individuals.

Abstract 351: Comparisons of a Pre- and Post-Behaviorally Modified Lifestyle Intervention for Reducing Cardiometabolic Risk in an Employee Population: My Unlimited Potential

Background: A major shortcoming of lifestyle improvement programs has been the difficulty in understanding the recruitment and follow-up strategies that yield the best results in terms of targeted health outcomes and retention rates. In this study, we compare the retention rates, short and long-term outcomes of a tailored workplace lifestyle intervention program targeted at high CVD risk working populations before and after implementation of changes made to the program based on a behavioral assessment (BA) analysis. Methods: The My Unlimited Potential (MyUP) is a year long lifestyle intervention program conducted among high-CVD risk employees of Baptist Health South Florida. The program was initially designed to have a 9-week intensive phase, with a year long follow-up period. During the intensive phase, participants had supervised structured physical fitness training as well as nutritional counseling. Due to concerns about sub-optimal retention rates and outcomes, the program was modified based on the results of a behavioral assessment of the initial participants (see figure). An additional level of participant screening was introduced with the aim of recruiting those who were least likely to drop-out and most likely to succeed in the program. The program was also modified to have a 12-week intensive phase. Results: At all follow-up periods, the retention rate was higher among those in the post BA group (see table). Although persons in the post-BA group achieved significantly greater reduction in weight, BMI and body fat the absolute differences between groups was minimal. The measured reduction in systolic (SBP) and diastolic blood pressures (DBP) were greater in the pre-BA group at the end of the intensive phase but this was reversed by 1 year in which only those who received the revised intervention had sustained reduction in DBP. There was no significant between-group difference in the laboratory parameter changes, including HbA1c and hsCRP. Conclusion: Using a behavioral assessment modification module improves retention rates with minimal improvement in outcomes. BA modification should be used in programs with low retention rates but may be of minimal impact on long term outcomes.

Health Coaching Effective for Obesity in Severe Mental Illness

Back to table of contents Previous article Next article Clinical and Research NewsFull AccessHealth Coaching Effective for Obesity in Severe Mental IllnessMark MoranMark MoranSearch for more papers by this authorPublished Online:6 Feb 2015https://doi.org/10.1176/appi.pn.2015.1b10AbstractHaving a health-promotion coach is associated with greatly increased fitness-club attendance, which in turn was linked with greater weight loss and improved cardiac fitness in those with serious mental illness.A health-coaching intervention for obesity appears to be effective in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese individuals with serious mental illness.That’s the finding of a replication trial of the In SHAPE program, the results of which were published December 12, 2014, in AJP in Advance.The report is “the first replication study confirming the effectiveness of a health-coaching intervention in achieving clinically significant reductions in cardiovascular risk for overweight and obese persons with serious mental illness and the first study to demonstrate persistent reduction in cardiovascular risk after the active intervention has been withdrawn,” said lead author Stephen Bartels, M.D., of the Department of Psychiatry and the Dartmouth Institute for Health Policy and Clinical Practice at the Geisel School of Medicine at Dartmouth and colleagues.In SHAPE is a 12-month program consisting of individual weekly meetings in the community with a health-promotion coach, a fitness-club (YMCA) membership, and nutrition education adapted for people with serious mental illness that was found in a previous study to contribute to clinically significant reduction in cardiovascular risk in overweight or obese adults with serious mental illness. In the new study, Bartels and colleagues randomly assigned 210 individuals with serious mental illness and a body-mass index greater than 25 receiving services in one of three community mental health organizations either to the 12-month In SHAPE program or to fitness-club membership alone. The primary outcome measures were weight and cardiorespiratory fitness (as measured with the six-minute walk test) assessed at baseline and at three-month intervals for 18 months.At 12 months, the In SHAPE group had greater reduction in weight and improved fitness compared with the fitness-club membership group. Primary outcomes were maintained at 18 months (see chart). Approximately half of the In SHAPE group achieved clinically significant cardiovascular risk reduction, defined by a weight loss greater than 5 percent or an increase of greater than 50 meters on the six-minute walk test.“By comparing In SHAPE to an active comparison condition (a fitness-club membership), we were able to test the specific contribution of having a health-promotion coach,” the researchers stated. “Having a health-promotion coach was associated with more than two-and-a-half times the mean amount of fitness-club attendance, which in turn was associated with greater weight loss and improved fitness.”They added that current efforts to increase life expectancy for people with serious mental illness are focused on improving the quality and delivery of primary health care by integrating “health homes” within mental health care. “These initiatives address the inadequate access to and poor quality of health care experienced by persons with mental illness,” they said. “However, only 10 percent to 15 percent of preventable mortality is estimated to be due to health care access and quality factors, in contrast to health behaviors, which are estimated to account for the majority (57 percent) of a population’s health status and 40 percent of early deaths. By also providing health promotion as a core service, it may be possible to further reduce early mortality while improving both the psychological and physical wellness of the whole person.” ■“Pragmatic Replication Trial of Health Promotion Coaching for Obesity in Serious Mental Illness and Maintenance of Outcomes” can be accessed here. ISSUES NewArchived

Set-based Design Method for Multi-objective Structural Design with Conflicting Performances Under Topological Change

In car manufacturing, sustainable structural design with multiple conflicting objectives like weight reduction for less CO2 emission, strength and rigidity is essential. This research focuses on topological optimization method with which greater weight reduction is expected to be achieved. In view of the application of preference set-based design (PSD) method, topologically satisfied design is considered. We applied PSD method to the design of topological model. This study indicates the efficacy of PSD method to topological design problems including weight reduction aspect.

Role of Mental Simulations in the Weight Loss Process

ABSTRACTTwo experiments were conducted to verify the influence of various mental simulations on the effectiveness and persistence of weight loss processes. In study one, 40 female students (aged 19–27, M = 23) who were eager to lose weight were randomly assigned to one of four groups: positive outcome simulation, process simulations, mixed simulations (process followed by negative outcome), and control (no simulations). Students from the mixed and process simulation groups lost significantly more weight after five weeks than participants from the outcome simulation and control groups. A total of 106 females (aged 19–45, M = 29) participated in study two, in which five types of mental simulations were tested. Besides the images used in study one, process followed by positive outcome simulations and negative outcome simulations were implemented. Results showed that process followed by positive outcome simulations lead to the highest persistence in the weight loss process, while process followed by negative outcome simulations induced the greatest reduction in weight. Both studies revealed self-regulatory benefits from mental simulations in difficult and long-term personal goal attainment.

Pragmatic replication trial of health promotion coaching for obesity in serious mental illness and maintenance of outcomes.

Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and none have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The authors sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population. Persons with serious mental illness and a body mass index (BMI) >25 receiving services in three community mental health organizations were recruited and randomly assigned either to the 12-month In SHAPE program, which included membership in a public fitness club and weekly meetings with a health promotion coach, or to fitness club membership alone. The primary outcome measures were weight and cardiorespiratory fitness (as measured with the 6-minute walk test), assessed at baseline and at 3, 6, 9, 12, and 18 months. Participants (N=210) were ethnically diverse (46% were nonwhite), with a mean baseline BMI of 36.8 (SD=8.2). At 12 months, the In SHAPE group (N=104) had greater reduction in weight and improved fitness compared with the fitness club membership only group (N=106). Primary outcomes were maintained at 18 months. Approximately half of the In SHAPE group (51% at 12 months and 46% at 18 months) achieved clinically significant cardiovascular risk reduction (a weight loss ≥5% or an increase of >50 meters on the 6-minute walk test). This is the first replication study confirming the effectiveness of a health coaching intervention in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese persons with serious mental illness.

Safety and efficacy of a novel plastic stent coated with stone-dissolving agents for the treatment of biliary stones in a porcine model.

We previously reported on a plastic stent that was coated with ethylenediaminetetraacetic acid (EDTA) and sodium cholate, which dissolved common bile duct (CBD) stones ex vivo. The aim of this study was to investigate the safety and efficacy of such stents on biliary stones in a live porcine model. Stents without coating or with degradable membranes containing 0 % or 50 % EDTA and sodium cholate were inserted together with human CBD stones into the porcine CBD. Serum laboratory variables, histological examinations of the bile duct, and the weight change in stones were compared during and after stent placement for 6 months. A total of 16 pigs were included (5 no coating, 5 0 % coating, 6 50 % coating). Biliary stones showed decreased weight in all groups; however, stones in the group with 50 % coated stents showed a greater reduction in weight compared with the no coating and the 0 % coating groups (269 ± 66 mg vs. 179 ± 51 mg [P = 0.09]; 269 ± 66 mg vs. 156 ± 26 mg [P = 0.01], respectively). The plastic stent coated with 50 % agent enhanced CBD stone dissolution in vivo and may be a promising tool for patients with difficult biliary stones.

Sex-specific differences in diabetes prevention: a systematic review and meta-analysis.

In people with prediabetes, lifestyle interventions and glucose-lowering medications are effective in preventing the progression to type 2 diabetes. It is unclear whether differences in treatment effects between men and women need to be taken into consideration when choosing a preventive strategy for an individual person. We systematically searched PubMed, the Cochrane Library, EMBASE, CINAHL, Web of Science, and reference lists of pertinent review articles from 1980 to June 2013. We conducted random effects meta-analyses of published and unpublished data to determine differences of treatment effects between men and women. Twelve randomised control trials (RCTs) provided sex-specific information on treatment effects. Compared with usual care, men and women who received lifestyle interventions had a lower rate of progression to type 2 diabetes (RR 0.60 [95% CI 0.35, 1.05] after 1 year; RR 0.63 [95% CI 0.51, 0.79] after 3 years); greater weight reduction (-2.45 kg; [95% CI -3.56, -1.33 kg] after 3 years); and greater reductions of fasting plasma glucose (-0.31 mmol/l [95% CI -0.48, -0.15] after 3 years) and 2 h post-challenge-glucose (-0.68 mmol/l [95% CI -1.03, -0.34] after 3 years). No statistically significant differences in treatment effects between men and women were apparent for any outcomes (p values of all comparisons ≥ 0.09). Our study emphasises the importance of preventive interventions in people with prediabetes and indicates no differences of beneficial preventive effects on the incidence of type 2 diabetes and weight gain between men and women.

Aggressive Risk Factor Reduction Study for Atrial Fibrillation and Implications for the Outcome of Ablation: The ARREST-AF Cohort Study

BackgroundThe long-term outcome of atrial fibrillation (AF) ablation demonstrates attrition. This outcome may be due to failure to attenuate the progressive substrate promoted by cardiovascular risk factors. ObjectivesThe goal of this study was to evaluate the impact of risk factor and weight management on AF ablation outcomes. MethodsOf 281 consecutive patients undergoing AF ablation, 149 with a body mass index ≥27 kg/m2 and ≥1 cardiac risk factor were offered risk factor management (RFM) according to American Heart Association/American College of Cardiology guidelines. After AF ablation, all 61 patients who opted for RFM and 88 control subjects were assessed every 3 to 6 months by clinic review and 7-day Holter monitoring. Changes in the Atrial Fibrillation Severity Scale scores were determined. ResultsThere were no differences in baseline characteristics, number of procedures, or follow-up duration between the groups (p = NS). RFM resulted in greater reductions in weight (p = 0.002) and blood pressure (p = 0.006), and better glycemic control (p = 0.001) and lipid profiles (p = 0.01). At follow-up, AF frequency, duration, symptoms, and symptom severity decreased more in the RFM group compared with the control group (all p < 0.001). Single-procedure drug-unassisted arrhythmia-free survival was greater in RFM patients compared with control subjects (p < 0.001). Multiple-procedure arrhythmia-free survival was markedly better in RFM patients compared with control subjects (p < 0.001), with 16% and 42.4%, respectively, using antiarrhythmic drugs (p = 0.004). On multivariate analysis, type of AF (p < 0.001) and RFM (hazard ratio 4.8 [95% confidence interval: 2.04 to 11.4]; p < 0.001) were independent predictors of arrhythmia-free survival. ConclusionsAggressive RFM improved the long-term success of AF ablation. This study underscores the importance of therapy directed at the primary promoters of the AF substrate to facilitate rhythm control strategies.

Adolescent weight control: an intervention targeting parent communication and modeling compared with minimal parental involvement.

Adolescent weight control interventions demonstrate variable findings, with inconsistent data regarding the appropriate role for parents. The current study examined the efficacy of a standard adolescent behavioral weight control (BWC) intervention that also targeted parent-adolescent communication and parental modeling of healthy behaviors (Standard Behavioral Treatment + Enhanced Parenting; SBT + EP) compared with a standard BWC intervention (SBT). 49 obese adolescents (M age = 15.10; SD = 1.33; 76% female; 67.3% non-Hispanic White) and a caregiver were randomly assigned to SBT or SBT + EP. Adolescent and caregiver weight and height, parental modeling, and weight-related communication were obtained at baseline and end of the 16-week intervention. Significant decreases in adolescent weight and increases in parental self-monitoring were observed across both conditions. Analyses of covariance revealed a trend for greater reduction in weight and negative maternal commentary among SBT condition participants. Contrary to hypotheses, targeting parent-adolescent communication and parental modeling did not lead to better outcomes in adolescent weight control.

A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial.

BackgroundType 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity.MethodsThis was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat.ResultsThis study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI −0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking control over the course of the study.ConclusionAmong Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being.Trial registrationClinicalTrials.gov Identified NCT00090506.

StomaphyX vs a Sham Procedure for Revisional Surgery to Reduce Regained Weight in Roux-en-Y Gastric Bypass Patients

Revisional laparoscopic surgery after Roux-en-Y gastric bypass (RYGB) has been linked to substantial complications and morbidity. To investigate the safety and effectiveness of endoscopic gastric plication with the StomaphyX device vs a sham procedure for revisional surgery in RYGB patients to reduce regained weight. A prospective, single-center, randomized, single-blinded study from July 2009 through February 2011, evaluating revisional surgery using StomaphyX was conducted in patients with initial weight loss after RYGB performed at least 2 years earlier. We planned for 120 patients to be randomized 2:1 to multiple full-thickness plications within the gastric pouch and stoma using the StomaphyX device with SerosFuse fasteners or a sham endoscopic procedure and followed up for 1 year. The primary efficacy end point was reduction in pre-RYGB excess weight by 15% or more excess body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) loss and BMI less than 35 at 12 months after the procedure. Adverse events were recorded. Enrollment was closed prematurely because preliminary results indicated failure to achieve the primary efficacy end point in at least 50% of StomaphyX-treated patients. One-year follow-up was completed by 45 patients treated with StomaphyX and 29 patients in the sham treatment group. Primary efficacy outcome was achieved by 22.2% (10) with StomaphyX vs 3.4% (1) with the sham procedure (P < .01). Patients undergoing StomaphyX treatment experienced significantly greater reduction in weight and BMI at 3, 6, and 12 months (P ≤ .05). There was one causally related adverse event with StomaphyX, that required laparoscopic exploration and repair. StomaphyX treatment failed to achieve the primary efficacy target and resulted in early termination of the study. clinicaltrials.gov Identifier: NCT00939055.

Long-term tolerance and efficacy of adjunctive exenatide therapy on glycaemic control and bodyweight in type 2 diabetes: a retrospective study from a specialist diabetes outpatient clinic.

Weight gain and hypoglycaemia are common adverse effects associated with anti-diabetic treatments. Our aim was to evaluate the long-term effects of adjunctive exenatide therapy on weight loss and glycaemic control in patients with type 2 diabetes. A review of medical records in a specialist diabetes clinic over 5 years identified 446 patients who were prescribed exenatide therapy. We examined change in glycosylated haemoglobin (HbA1c), weight, albumin-creatinine ratio and hypoglycaemic medication during 24 months follow up. Subjects were aged 59 ± 10 years (49% women) and received exenatide in combination with oral agents and insulin (47%). During an average of 17 ± 14 months follow up, 51% (more women than men; odds ratio 1.69, 95% confidence interval 1.14–2.49) remained on treatment. Lack of efficacy (33%) and/or gastrointestinal (27%) side-effects were the main reasons for treatment cessation. At 24 months, there was a reduction in HbA1c of 0.7 ± 1.2% and weight loss of 4.3 ± 5.2 kg. Change in HbA1c was similar regardless of concurrent insulin therapy, yet insulin was associated with greater weight reduction (4.8 ± 5.3 vs 3.8 ± 5.1 kg, P = 0.016). Independent predictors of HbA1c response were higher baseline HbA1c, longer duration of diabetes and use of insulin or sulfonylureas at study end. Predictors of weight response were baseline use of insulin or thiazolidinediones, increased age, female sex and sulfonylurea or thiazolidinediones at study end. Longer exenatide treatment duration was favourable for reducing HbA1c and weight. Exenatide is effective in reducing HbA1c and weight, regardless of concurrent insulin, and in a specialist diabetes outpatient clinic, is recommended for use in clinical practice.

Abstract MP33: The Deaf Weight Wise Study: A Unique Clinical Trial of Health Behavior Modification with Deaf Adults

Introduction: Deaf people who use American Sign Language (ASL) comprise linguistic and cultural minority populations without access to language-concordant health information and healthcare. Deaf ASL users are rarely included in health research or public health surveillance. Recent research with Deaf ASL users found a higher prevalence of obesity than in the general population. No randomized trials of lifestyle modification or weight reduction have ever been attempted with Deaf ASL users. Methods: We worked with the Rochester (NY) Deaf community to adapt a 16-week healthy lifestyle program previously shown to be effective with hearing people. We adapted the curriculum and research measures to be culturally and linguistically appropriate. We used a group intervention format recommended by our Deaf partners, and trained group leaders who were Deaf, ASL fluent and had backgrounds in counseling, public health, or healthcare. For this Deaf Weight Wise (DWW) trial, we recruited Deaf adults aged 40-70 with a BMI of 25-45 from community settings, and randomized participants to immediate intervention or intervention delayed 1 year. We will collect data from DWW trial participants over two years. We present analyses of data after 6 months here. Primary outcomes were changes in weight, BMI and scores on two standard measures: Dietary Risk Assessment (DRA) and Physical Activity Assessment (PAA). We used group by time repeated measures ANOVA to examine changes from baseline to 6 months for the immediate group and delayed group (no intervention yet). Hypothesis: The immediate intervention group would have greater reduction in weight and BMI as well as improvement in DRA and PAA scores six months after baseline compared with the delayed intervention group. Results: At baseline, the 104 participants’ mean age was 53.5 years; 68.3% (71 of 104) were female and 91.3% (95/104) were White. Randomization was successful based on baseline data. At 6 months, the immediate group weight changed -3.35kg (1.0 s.e.; p=.002) and BMI changed -1.35 (0.4 s.e.; p≤.0001) compared with the delayed group. Most of the immediate group (58.3%, 28/48) lost ≥ 5% of baseline weight versus 14.3% (8/56) of the delayed group (p≤.0001). Changes in mean DRA (p=.055) and moderate PAA (p=.054) scores numerically favored the immediate group. Conclusions: Deaf Weight Wise is the first randomized controlled trial of a healthy lifestyle program with Deaf ASL users. This culturally appropriate and language accessible behavioral intervention was feasible and highly effective with this underserved and rarely studied population.

EP News: Clinical

Abed and colleagues (JAMA. 2013 Nov 20; 310 (19):2050-60; PMID: 24240932) evaluated the effect of weight reduction on atrial fibrillation (AF) burden and cardiac structure in a randomized controlled trial. Obese patients with symptomatic AF (150) were randomized to weight management (intervention) or general lifestyle advice (control). The primary outcomes were AF Severity Scale scores, symptom burden, and symptom severity. Secondary outcomes were AF episodes and AF duration, left atrial area, and septal thickness. The intervention group showed a significantly greater reduction in weight (14.3 and 3.6 kg, respectively; P < .001) and in AF symptom burden scores (11.8 and 2.6 points, P < .001), symptom severity scores (8.4 and 1.7 points, P < .001), and cumulative AF duration (692-minute decline and 419-minute increase, P = .002). There was a reduction in septal thickness in the intervention and control groups (1.1 and 0.6 mm, P = .02) and left atrial area (3.5 and 1.9 cm2, P = .02). The authors conclude weight reduction with intensive risk factor management reduces AF symptom burden and severity and in beneficial cardiac remodeling.

Hybrid Technologies for Joining Ultra-high-strength Boron Steels with Aluminum Alloys for Lightweight Car Body Structures

Lightweight design in car body engineering enables the reduction of energy consumption and greenhouse gas emissions of cars, which is crucial to fulfill the increasing legislative restrictions and market demand for eco-friendly mobility. The challenge is to realize more lightweight and at the same time still rigid and crash-stable car bodies, that are affordable for a large-scale production. For cars for high volume markets, an intelligent load-oriented multi-material design with intensive use of ultra-high-strength hot-stamped boron steels combined with modern aluminum alloy sheets and cast is often the optimal solution, as these materials offer a great weight reduction potential at reasonable costs. The lack of suitable cost-efficient joining technologies for these material combinations is one of the most important barriers for the realization of affordable cars in volume productions. This paper presents and overview about recent developments and research results for suitable joining technologies.

Abstract 18552: Six Months of a Low-Carbohydrate versus Low-Fat Weight Loss Diet Plus Exercise: Effects on Resting and Postprandial Endothelial Function

Background: A worry about low-carbohydrate (CHO) diets is that higher fat meals may adversely affect vascular function acutely, and the regular eating of such meals may lead to chronic vascular impairment. We hypothesized that the effects of a low-CHO vs. low-fat weight loss diet, each combined with exercise training for 6-months, would have similar effects on resting and postprandial endothelial function. Methods: Persons (n=77), BMI 25-42 kg/m2, 30-65 years, were randomly assigned to a low-CHO or low-fat diet, plus exercise. At 0 and 6 months, reactive hyperemia was induced after 5 minutes of upper arm occlusion of SBP. The reactive hyperemia peripheral arterial tonometry index (RH-PAT), a measure of endothelial function, was obtained at rest and 4 hours after eating a McDonald’s breakfast (900 calories, 50 fat grams). We also measured body weight, BMI, and total body fat and trunk fat % by dual-energy X-ray absorptiometry. Results: Sixty subjects (low-CHO group: n=31, 74% female; low-fat group, n=29, 72% female) completed the study. At 0 months, there were no group differences in the following and the combined values are: age, 50.0±8.7 years; weight, 215.4±32.7 lbs; BMI, 34.2±3.8 kg/m2; total body fat, 43.3±7.2%; trunk fat, 46.4±5.7%; RH-PAT, 2.32±0.44%. At 0 months, RH-PAT did not change in response to the meal in either group, overall -0.05±0.64, p=.58. At 6 months, low-CHO vs. low-fat subjects had a greater reduction in weight, -28.9±11.0 vs. -18.7± 2.0 lbs., p&lt;.01; BMI, -4.7±2.0 vs. -2.9±1.7, p&lt;.01; body fat, -6.8±4.5 vs. -4.0±3.9%, p&lt;.02. The groups did not differ in loss of trunk fat, with an overall drop of - 5.5±5.7%, p&lt;.01. At 6 months, there was no change in resting RH-PAT in either group vs. 0 months, overall +0.03±0.53, p=.64 and no group difference in resting vs. postprandial RH-PAT, overall -0.08±0.69, p=.34. Though the 6-month mean resting RH-PAT did not improve, each absolute 1% drop in trunk fat % was associated with an absolute 0.29% (relative 12.5%) increase in RH-PAT, p=.05. Body composition changes did influence postprandial RH-PAT. Conclusions: We found no adverse effects of 6-months of a low-CHO diet on resting or postprandial endothelial function. Central fat loss was associated with improved vascular function, regardless of diet.