Uncontrolled Type 2 Diabetes Research Articles

Effect of Dairy Consumption and Its Fat Content on Glycemic Control and Cardiovascular Risk Factors in Patients with Type 2 Diabetes—A Randomized Controlled Study

The 2015 Dietary Guidelines for Americans recommend daily consumption of 3 servings of low or non-fat dairy. However, the effects of dairy consumption and its fat content on glycemic control and cardiovascular risk factors in patients with type 2 diabetes (T2D) are unknown. This study was designed to evaluate the impact of higher consumption of full-fat and low/non-fat dairy on HbA1c, lipid profile and blood pressure (BP) in patients with T2D. We enrolled 72 participants with uncontrolled T2D (mean age 59±8 years, 46% females) who were consuming <3 servings of dairy/day and randomized them into 3 groups. Group A was asked to incorporate ≥3 daily servings of full-fat dairy and group B to incorporate ≥3 daily servings of low/ non-fat dairy into their diet. Group C was asked to maintain the baseline dairy intake. Participants were counseled by a registered dietitian about maintaining their daily caloric intake and body weight. They were asked to maintain their usual doses of diabetes, antihypertensive and hypolipidemic medications. Participants were evaluated at baseline, 3 and 6 months. At baseline, mean T2D duration was 14±8 years, HbA1c 8.1±1.0%, body weight 92±17 kg, daily caloric intake 1885±600 kcal (43.4±7.0% carbohydrates, 37.8±5.5% fat, 13.0±2.8% saturated fat, and 18.1±3.6% protein), LDL-C 80±26 mg/dL, HDL-C 47±16 mg/dL, triglycerides 172±178 mg/dL, systolic BP 129±16 mmHg and diastolic BP 72±8 mmHg. There were no differences between groups in any of these parameters at baseline. At 6 months, percent calories from saturated fat increased by 3.7±0.8% in group A (p<0.0001), and decreased by 4.4±1.7% in group B (p=0.014). There were no differences in HbA1c, body weight, total caloric intake or percent calories from carbohydrates, lipid parameters or BP between groups. This study shows that increasing consumption of dairy products to ≥3 servings/day, irrespective of fat content, has no effect on HbA1c, lipid profile or BP in patients with T2D. Disclosure A. Mottalib: None. J. Mitri: Research Support; Self; National Dairy Council, Kowa Pharmaceuticals America, Inc.. Research Support; Spouse/Partner; AbbVie Inc., Janssen Pharmaceuticals, Inc., Takeda Pharmaceuticals U.S.A., Inc., Gilead Sciences, Inc.. Consultant; Spouse/Partner; Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Biogen, AbbVie Inc.. V. Salsberg: None. S. Ashrafzadeh: None. T. Elseaidy: None. S. Tomah: None. K. Alsibai: None. N. Mahmoud: None. O. Hamdy: Research Support; Self; Abbott. Advisory Panel; Self; AstraZeneca. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Healthimation, LLC.. Consultant; Self; Sanofi-Aventis.

The Mediterranean Diet and Two-Year Changes in Cognitive Function in Puerto Rican Adults With vs. Without Type 2 Diabetes

People with type 2 diabetes (T2D), especially uncontrolled T2D, have high risk of cognitive decline. The role of a Mediterranean diet on cognitive function has not been assessed for adults with vs. without T2D within the same population. We aimed to determine associations of a Mediterranean diet score (MeDS) with 2 year changes in cognitive function by T2D status and by glycemic control status. We used data from the Boston Puerto Rican Health Study (mean (SD) age= 57.2 (7.6) y; n=711 without T2D; n=465 with T2D defined as fasting plasma glucose ≥ 126 mg/dL or medication use). Glycemic control at baseline was categorized as uncontrolled (hemoglobin A1c ≥7%; 74% of T2D sample)) vs. controlled (26%). Two-y changes in glycemic control were defined as stable/improved (32%) vs. poor/declined (68%). Baseline MeDS ranged from 0-9 by scoring participants within the sex-specific healthy median intake of 9 foods and nutrients. The primary outcome was 2 year change in global cognitive function z-score, which included 7 cognitive tests. Adjusting for baseline sociodemographic and lifestyle factors, comorbidities, and baseline measure, MeDS was positively associated with 2 year change in global cognitive function in adults with T2D (β ± SE=0.027 ± 0.011; p=0.016) but not without T2D (-0.002 ± 0.008; p=0.80). Similar results were noted for single cognitive tests (i.e., mini-mental state examination, word recognition, digit span, clock drawing). Better global cognitive function over 2 years with higher MeDS was noted with glycemic control at baseline (0.062 ± 0.020; p=0.004) or stable/improved over 2 years (0.053 ± 0.019; p=0.007), but not for uncontrolled or poor/declined glycemic control. Adhering to a Mediterranean diet is associated with positive 2 year changes in cognitive function among adults with T2D. Glycemic control further sustains these benefits, suggesting that both a healthy Mediterranean diet and effective clinical management may help preserve optimal cognitive function in adults with T2D. Disclosure J. Mattei: None. S.J. Bigornia: None. M. Sotos-Prieto: None. T. Scott: None. X. Gao: None. K.L. Tucker: None.

Patient-Reported Outcomes (PROs) for Insulin Degludec/Liraglutide (IDegLira) vs. Insulin Glargine (IGlar U100) as Add-On to Sodium-Glucose Co-Transporter-2 Inhibitor (SGLT2i) ± Oral Antidiabetic Drug (OAD) Therapy in Patients with Type 2 Diabetes (T2D)—DUAL IX Trial

In DUAL IX, a 26-week, phase 3b, treat-to-target, open-label trial, patients with uncontrolled T2D on SGLT2i ± OADs (N=420) were randomized 1:1 to once-daily IDegLira or IGlar U100 (100 units [U]/mL) add-on therapy. IDegLira was superior to IGlar U100 for A1C (1.9 vs. 1.7% reduction), body weight (0.0 vs. 2.0 kg gain) and hypoglycemia rate (58% lower with IDegLira). PROs were measured at baseline and week 26 with the 5-domain Treatment Related Impact Measure-Diabetes (TRIM-D) questionnaire, with higher scores indicating better outcomes. After 26 weeks, improvements were significantly greater with IDegLira vs. IGlar U100 in total TRIM-D, Treatment Burden domain and especially Diabetes Management domain (Table), including 4 of the 5 individual items (estimated treatment ratio [95% confidence interval]): help you control your diabetes: 2.17 [1.47; 3.21], p<0.0001; help you avoid hyperglycemia: 1.95 [1.32; 2.87], p=0.0007; help you avoid hypoglycemia: 1.62 [1.12; 2.36], p=0.0105; help you manage your weight: 2.44 [1.69; 3.52], p<0.0001; help you prevent feeling tired/lack of energy: 1.36 [0.95; 1.96], p=0.0945. In conclusion, vs. IGlar U100, IDegLira treatment resulted in better clinical and treatment management outcomes. Disclosure M. Brod: Consultant; Self; Novo Nordisk A/S. L.K. Billings: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S, Dexcom, Inc. R.S. Busch: Speaker's Bureau; Self; AbbVie Inc., AstraZeneca. Research Support; Self; Bayer AG, Intarcia Therapeutics, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Amgen Inc.. Research Support; Self; Sanofi US. Speaker's Bureau; Self; Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc.. Research Support; Self; Amarin Corporation. S. Harris: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Amgen Inc., Lilly/Boehringer Ingelheim, Abbott, Janssen. Consultant; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Lilly/Boehringer Ingelheim, Abbott, Janssen. Research Support; Self; Novo Nordisk A/S, Sanofi, Merck, Abbott, AstraZeneca, Janssen. Other Relationship; Self; CIHR, CDA, The Lawson Foundation. C. Morales Portillo: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Abbott. Research Support; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Theracos, Inc., Lexicon Pharmaceuticals, Inc.. Speaker's Bureau; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Abbott. R. Sahay: Advisory Panel; Self; Boehringer Ingelheim, Sanofi, Eli Lilly and Company, Novo Nordisk A/S. Advisory Panel; Spouse/Partner; Intas Pharmaceuticals Ltd., Pfizer Inc.. Speaker's Bureau; Self; Sanofi, Eli Lilly and Company, Boehringer Ingelheim, Dr. Reddys Laboratories, USV Private Limited, Glenmark. Speaker's Bureau; Spouse/Partner; Boehringer Ingelheim. A. Busk: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. S. Eggert: Employee; Self; Novo Nordisk A/S. N. Halladin: Employee; Self; Novo Nordisk A/S. A. Philis-Tsimikas: Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Novo Nordisk A/S, Sanofi, Mylan. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Esperion Therapeutics, Ionis Pharmaceuticals, Inc.. Advisory Panel; Self; AstraZeneca.

Randomized Trial of a Tailored Cognitive Behavioral Intervention in Type 2 Diabetes with Comorbid Depressive and/or Distress Symptoms—Twelve-Month Outcomes from COMRADE

Patients with type 2 diabetes (T2D) and co-morbid depressive and/or distress symptoms have poor glycemic control and worse health outcomes. This prospective randomized controlled trial evaluated the effectiveness of a 16-session severity tailored cognitive behavioral intervention plus lifestyle change counseling (n = 67; IG=intervention group) delivered by trained staff compared to usual care (n = 72; CG=control group), in 139 rural adult patients (mean age = 52.6 ± 9.5 years.; 72% black; BMI = 37.0 ± 9.0) with uncontrolled (mean HbA1c = 9.6 ± 2.0) T2D (52% on insulin) and co-morbid depressive (PHQ-2) or distress (DDS-2) symptoms at screening in an academic primary care clinic. At baseline and at 12-month follow-up: height, weight, BP, A1c, diabetes distress (DDS-17), depressive symptoms (PHQ-9), self-care behaviors (SDSCA), empowerment (DES), and medication adherence (ModMAS) were measured using validated instruments. There were no differences between groups at baseline. Between group (IG vs. CG) differences at 12-months follow-up were significant for changes from baseline in diabetes-related distress (-0.83 ± 0.88 vs. -0.15 ± 0.92; p = 0.001), regimen-related distress (-1.12 ± 1.vs. -0.31 ± 1.22; p = 0.001), depressive symptoms (-3.39 ± 5.00 vs. -0.90 ± 6.17; p = 0.01), self-care behaviors (+1.10 ± 1.30 vs. +0.58 ± 1.45; p = 0.03), and medication adherence (+1.00 ± 2.0 vs. +0.17 ± 1.0; p = 0.02). Differences in change in A1c (-0.92 ± 1.81 vs. -0.31 ± 2.04; p = 0.06) were substantially greater in the intervention group and achieved borderline significance. There were no significant differences in glycemic response patterns by race or gender. A tailored cognitive behavioral intervention significantly improves behavioral outcomes and glycemic control in rural black and white patients with T2D and co-morbid depressive and/or distress symptoms. Disclosure D.M. Cummings: None. L. Lutes: None. S. Patil: None. B. Hambidge: None. M. Carraway: None. K. Littlewood: None. A. Adams: None. C. Solar: None. S. Edwards: None. P. Gatlin: None.

Treatment Intensification in Type 2 Diabetes: A Real-World Study of 2-OAD Regimens, GLP-1 RAs, or Basal Insulin.

IntroductionTreatment guidelines recommend a stepwise approach to glycemia management in patients with type 2 diabetes (T2D), but this may result in uncontrolled glycated hemoglobin A1c (HbA1c) between steps. This retrospective analysis compared clinical and economic outcomes among patients with uncontrolled T2D initiating two oral antidiabetes drugs (OADs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or basal insulin in a real-world setting.MethodsAdults with T2D on OAD monotherapy were identified in the MarketScan claims database (2007–2014). Those initiating two OADs (simultaneously or sequentially), GLP-1 RAs, or basal insulin were selected (date of initiation was termed the ‘index date’); patients were required to have HbA1c > 7.0% in the 6 months pre-index date. HbA1c was compared from 6 months pre- to 1-year post-index. Annual all-cause healthcare utilization and costs were reported over the 1-year follow-up period.ResultsData for 6054 patients were analyzed (2-OAD, n = 4442; GLP-1 RA, n = 361; basal insulin, n = 1251). Baseline HbA1c was high in all cohorts, but highest in the basal-insulin cohort. Treatment initiation resulted in reductions in HbA1c in all cohorts, which was generally maintained throughout the follow-up period. Average HbA1c reductions from the 6 months pre- to 1 year post-index date were −1.2% for GLP-1 RA, −1.6% for OADs, and −1.8% for basal insulin. HbA1c < 7.0% at 1 year occurred in 32.6%, 47.5%, and 41.1% of patients, respectively. Annual healthcare costs (mean [SD]) were lowest for OAD (US$10,074 [$22,276]) followed by GLP-1 RA (US$14,052 [$23,829]) and basal insulin (US$18,813 [$37,332]).ConclusionDespite robust HbA1c lowering following treatment initiation, many patients did not achieve HbA1c < 7.0%. Basal insulin, generally prescribed for patients with high baseline HbA1c, was associated with a large reduction in HbA1c and with higher costs. Therapy intensification at an appropriate time could lead to clinical and economic benefits and should be investigated further.FundingSanofi U.S., Inc.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0429-x) contains supplementary material, which is available to authorized users.

Assessment of memory and cognitive functions in controlled and uncontrolled Type 2 diabetes mellitus patients

Background: In Type 2 diabetes (T2D) mellitus, chronic hyperglycemia and hyperinsulinemia with resultant increased advanced glycosylated end products cause the acceleration of the brain aging in its structure and functions. This complication increases the risk of memory and cognitive dysfunctions. Aims and Objectives: This study was aimed to compare the memory and cognitive functions between controlled and uncontrolled T2D mellitus patients. Materials and Methods: The study is undertaken in the Department of Physiology, Velammal Medical College Hospital, Madurai. 100 known T2D mellitus patients aged between 30 and 50 years of both sexes are included after obtaining informed written consent. Patients with conditions and factors affecting memory and patients with defective hearing and speech are excluded from the study. Recent hemoglobin A1c (HbA1c), fasting blood sugar (FBS), and postprandial blood sugar (PPBS) values are collected from their hospital records. Cognition and memory assessment is done using Mini-Mental State Examination (MMSE) by 30-point questionnaire. Results: The average MMSE score of uncontrolled diabetes mellitus is less than the average MMSE score of controlled diabetes mellitus patients (HbA1c

Effects of Vildagliptin Add-on Insulin Therapy on Nocturnal Glycemic Variations in Uncontrolled Type 2 Diabetes.

IntroductionTo investigate whether vildagliptin add-on insulin therapy improves glycemic variations in patients with uncontrolled type 2 diabetes (T2D) compared to patients with placebo therapy.MethodsThis was a 24-week, single-center, double-blind, placebo-controlled trial. Inadequately controlled T2D patients treated with insulin therapy were recruited between June 2012 and April 2013. The trial included a 2-week screening period and a 24-week randomized period. Subjects were randomly assigned to a vildagliptin add-on insulin therapy group (n = 17) or a matched placebo group (n = 16). Scheduled visits occurred at weeks 4, 8, 12, 16, 20, and 24. Continuous glucose monitoring (CGM) was performed before and at the endpoint of the study.ResultsA total of 33 subjects were admitted, with 1 patient withdrawing from the placebo group. After 24 weeks of therapy, HbA1c values were significantly reduced at the endpoint in the vildagliptin add-on group. CGM data showed that patients with vildagliptin add-on therapy had a significantly lower 24-h mean glucose concentration and mean amplitude of glycemic excursion (MAGE). At the endpoint of the study, patients in the vildagliptin add-on group had a significantly lower MAGE and standard deviation compared to the control patients during the nocturnal period (0000–0600). A severe hypoglycemic episode was not observed in either group.ConclusionVildagliptin add-on therapy to insulin has the ability to improve glycemic variations, especially during the nocturnal time period, in patients with uncontrolled T2D.

Type 2 diabetes as a risk indicator for dental caries in Korean adults: the 2011-2012 Korea national health and nutrition examination survey.

The associations between type 2 diabetes (T2D) and untreated dental caries was examined. This study hypothesized that there would be a positive association between T2D and the prevalence of decayed permanent teeth (DT) in representative Korean adults. The information was derived from the Korea National Health and Nutrition Examination Survey conducted in 2011-2012. Sociodemographic and lifestyle variables, anthropometric and biochemical status, metabolic health and glucose tolerance status, oral health behaviors, and dental caries index were evaluated. The number of DT had a positive association with degree of fasting plasma glucose (FPG) level, and glycated hemoglobin (HbA1c) (p-value = 0.045 and 0.007, respectively). The levels of FPG and HbA1c increased with the number of DT (p for trend = 0.009 and 0.004, respectively). The prevalence of untreated caries uncontrolled T2D participants was about 26% higher than those with normal glucose tolerance levels after adjusting for potential confounders including diets and socioeconomic status (OR [95% CI] = 1.26 [1.02, 1.56]). T2D is an independent risk indicator for untreated caries in Korean adults.

Efficacy and Safety of Linagliptin in 2681 Asian Patients Stratified by Age, Obesity, and Renal Function: A Pooled Analysis of Randomized Clinical Trials.

IntroductionAsian patients with type 2 diabetes (T2D) are younger, leaner, and more likely to develop renal dysfunction than White populations. In this multiethnic analysis of data from phase 3 trials, we investigated the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in Asians stratified by these subphenotypes.MethodsData from randomized, double-blind, placebo-controlled trials evaluating linagliptin (as monotherapy, add-on therapy to metformin ± sulfonylurea, combined with pioglitazone or added to insulin) were pooled with efficacy data from 11 randomized trials of at least 24 weeks and safety data from 15 trials of various durations.ResultsIn the efficacy set, 1404 Asian patients received linagliptin [mean (standard deviation) age 54.5 (10.1) years; body mass index (BMI) 26.0 (3.9) kg/m2] and 661 received placebo [age 55.0 (9.7) years; BMI 26.1 (3.9) kg/m2] with the same glycated hemoglobin (HbA1c): 8.2 (0.9)% in both groups. At 24 weeks, the placebo-corrected adjusted mean ± standard error change from baseline in HbA1c with linagliptin was −0.73 ± 0.04% (95% confidence interval −0.81, −0.65; P < 0.0001). Reductions in HbA1c were similar upon stratification by age [<65 years, −0.71 ± 0.05% (−0.80, −0.62; P < 0.0001); ≥65 years, −0.81 ± 0.10% (−1.01, −0.60; P < 0.0001)], BMI (<25 kg/m2, −0.82 ± 0.06% [−0.94, −0.70; P < 0.0001]; ≥25 kg/m2, −0.65 ± 0.06% [−0.76, −0.54; P < 0.0001]) and estimated glomerular filtration rate [<90 mL/min/1.73 m2, −0.71 ± 0.06% (−0.82, −0.60; P < 0.0001); ≥90 mL/min/1.73 m2, −0.75 ± 0.06% (−0.87, −0.64; P < 0.0001)]. In the safety set (linagliptin, n = 1842; placebo, n = 839), 52.2% and 54.6% of patients, respectively, experienced adverse events. The rates of drug-related adverse events were 10.9% in the linagliptin group and 10.4% in the placebo group. The respective rates of hypoglycemia were 8.3% and 9.5%, mainly among patients treated with sulfonylurea or insulin. Severe hypoglycemia was rare (<1.0% in either group).ConclusionLinagliptin effectively reduced hyperglycemia in Asian patients with uncontrolled T2D, irrespective of age, BMI, renal function, or ethnic subgroups, and was well tolerated.FundingBoehringer Ingelheim, Eli Lilly and Company, and the Diabetes Alliance.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-017-0595-7) contains supplementary material, which is available to authorized users.

Impact of Glycemic Variability on Chromatin Remodeling, Oxidative Stress, and Endothelial Dysfunction in Patients With Type 2 Diabetes and With Target HbA1c Levels.

Intensive glycemic control (IGC) targeting HbA1c fails to show an unequivocal reduction of macrovascular complications in type 2 diabetes (T2D); however, the underlying mechanisms remain elusive. Epigenetic changes are emerging as important mediators of cardiovascular damage and may play a role in this setting. This study investigated whether epigenetic regulation of the adaptor protein p66Shc, a key driver of mitochondrial oxidative stress, contributes to persistent vascular dysfunction in patients with T2D despite IGC. Thirty-nine patients with uncontrolled T2D (HbA1c >7.5%) and 24 age- and sex-matched healthy control subjects were consecutively enrolled. IGC was implemented for 6 months in patients with T2D to achieve a target HbA1c of ≤7.0%. Brachial artery flow-mediated dilation (FMD), urinary 8-isoprostaglandin F2α (8-isoPGF2α), and epigenetic regulation of p66Shc were assessed at baseline and follow-up. Continuous glucose monitoring was performed to determine the mean amplitude of glycemic excursion (MAGE) and postprandial incremental area under the curve (AUCpp). At baseline, patients with T2D showed impaired FMD, increased urinary 8-isoPGF2α, and p66Shc upregulation in circulating monocytes compared with control subjects. FMD, 8-isoPGF2α, and p66Shc expression were not affected by IGC. DNA hypomethylation and histone 3 acetylation were found on the p66Shc promoter of patients with T2D, and IGC did not change such adverse epigenetic remodeling. Persistent downregulation of methyltransferase DNMT3b and deacetylase SIRT1 may explain the observed p66Shc-related epigenetic changes. MAGE and AUCpp but not HbA1c were independently associated with the altered epigenetic profile on the p66Shc promoter. Hence, glucose fluctuations contribute to chromatin remodeling and may explain persistent vascular dysfunction in patients with T2D with target HbA1c levels.

Vildagliptin has the same safety profile as a sulfonylurea on bone metabolism and bone mineral density in post-menopausal women with type 2 diabetes: a randomized controlled trial

BackgroundSeveral antidiabetic therapies affect bone metabolism. Sulfonylureas have the lowest impact on bone among oral antidiabetics. The objective of this study is to compare the effects of vildagliptin and gliclazide modified release (MR) on bone turnover markers (BTMs) and bone mineral density (BMD) in postmenopausal women with uncontrolled type 2 diabetes (T2D).MethodsForty-two postmenopausal women with uncontrolled T2D were randomly allocated into vildagliptin or gliclazide MR (control) groups. The primary endpoint was the change in the BTMs in months 6 and 12 compared with the baseline. The secondary endpoint was the variation in the BMD, which was assessed via dual-energy X-ray absorptiometry at the lumbar spine, femoral neck and total hip at baseline and month 12.ResultsAfter a 12-month treatment, the BTM serum carboxy-terminal telopeptide of type 1 collagen increased 0.001 ± 0.153 ng/mL in the vildagliptin group versus 0.008 ± 0.060 ng/mL in the gliclazide MR group (p = 0.858). The serum osteocalcin, serum amino-terminal propeptide of procollagen type I and urinary amino-terminal telopeptide of type 1 collagen remained stable in both groups, and there was no statistically significant difference between the effect of vildagliptin and gliclazide MR on these variables. The lumbar spine BMD did not change in the vildagliptin or gliclazide MR groups after a 12-month treatment (0.000 ± 0.025 g/cm2 versus −0.008 ± 0.036, respectively, p = 0.434). Furthermore, there was a similar lack of change in the femoral neck and total hip BMD values in both treatments.ConclusionsBone turnover markers and BMD remained unchanged after a 12-month treatment in both groups, which suggests that vildagliptin has the same safety profile as gliclazide MR on bone metabolism.Trial Registration ClinicalTrials.gov number NCT01679899

Microbial Etiology of Bacteremia in Controlled and Uncontrolled Type-2 Diabetes in Eastern Part of India

Bacteremia in Type 2 Diabetes (T2D) is the most serious public health issue. Very limited information is available in this aspect with reference to complications. We hypothesized that abnormal increase in blood sugar levels may result in different bacterial infection associated with different categories of complications. Therefore, the aim of the present study was to evaluate and investigate the possible causes of bacteremia in T2D patients and its related complications in eastern region of the country where the data is unavailable to the best of our knowledge. The study included a total of 244 established T2D patients and 20 healthy controls in and around Bhubaneswar region, Odisha. Staging of T2D was done as per standard criteria into controlled and uncontrolled T2D. Blood samples were collected from all subjects including healthy controls and culture was done for bacterial isolation, identification. Prevalence of bacteremia was more among the uncontrolled cases (70.1%) than the controlled ones (29.8%) compared to healthy controls with p<0.0001. Occurrence of both gram positive and gram negative bacteria were found which comprised of Staphylococcus sp., Streptococcus, Bacilli, E. coli, Klebsiella. These groups of bacteria were thought as the causes of T2D complications. Eastern region of India being called as sweet region have a great affinity towards food and entertainment. So, we expect a higher intensity of sugar level in their blood and culture which often remains undiagnosed and develop to complications. Therefore, in our results we evaluated a strong connection of hyperglycemia with bacteremia providing a key for good empiric treatment in such high risk population.

Glycemic Control and Weight Outcomes for Exenatide Once Weekly Versus Liraglutide in Patients with Type 2 Diabetes: A 1-Year Retrospective Cohort Analysis

PurposeData comparing real-world effectiveness of the glucagon-like peptide-1 receptor agonists (GLP-1RAs) exenatide once weekly (QW) and liraglutide in the treatment of type 2 diabetes (T2D) are limited. Furthermore, there is limited information on exenatide QW or liraglutide response by glycemic control and insulin use status. This study identifies 1-year glycosylated hemoglobin (HbA1c) and weight outcomes with exenatide QW and liraglutide in the real-world setting overall and in insulin-naive patients with uncontrolled T2D. MethodsThis retrospective cohort study using national electronic medical record data compared 1-year HbA1c and weight outcomes in patients with T2D prescribed exenatide QW or liraglutide. Included patients were adults (≥18 years old) with T2D who were GLP-1RA naive when newly prescribed exenatide QW or liraglutide between January 1, 2012, and March 31, 2013 (index date). Outcomes were reported descriptively overall and in subsets of insulin-naive patients with baseline HbA1c ≥7.0% or ≥9.0%. Multivariable linear regression analyses were performed to estimate adjusted change in HbA1c and weight. FindingsThe study included 808 exenatide QW and 4333 liraglutide patients. Mean (SD) age was 57 (11) years in both groups. Mean baseline HbA1c was 8.3% (1.5%) in exenatide QW patients and 8.4% (1.6%) in liraglutide patients (P = 0.66); 16 (2%) of the exenatide QW and 1099 (25.4%) of the liraglutide patients were newly prescribed insulin on the index date (P < 0.001). Adjusted mean HbA1c change at 1 year was −0.37% (95% CI, −0.53% to −0.21%) for exenatide QW and −0.37% (95% CI, −0.55% to −0.18%) for liraglutide. Adjusted HbA1c reduction was more pronounced in insulin-naive patients with baseline HbA1c ≥7.0% (−0.71% and −0.80% for the exenatide QW and liraglutide patients, respectively, P > 0.05) and ≥9.0% (−1.73% and −1.57% for exenatide QW and liraglutide patients, respectively, P > 0.05). Mean (adjusted) weight loss was −2.22 kg (95% CI, −3.06 to −1.37 kg) with exenatide QW and −2.21 kg (95% CI, −3.18 to −1.23 kg) with liraglutide. ImplicationsExenatide QW and liraglutide lead to similar HbA1c and weight reductions at 1 year in the real-world setting. Greater HbA1c reductions occurred in insulin-naive patients with baseline HbA1c ≥7.0%. Both agents are appropriate options for patients needing antidiabetes therapy to lower HbA1c while promoting weight loss.

Faster-Acting Insulin Aspart vs. Insulin Aspart in Basal-Bolus Therapy Improved Postprandial Glycemic Control in Uncontrolled T2D in the Onset® 2 Trial

A multicentre, double-blind, treat-to-target trial evaluated the efficacy of faster-acting insulin aspart (faster aspart) vs. insulin aspart (IAsp) in adults with uncontrolled type 2 diabetes (T2D) on basal insulin and oral antidiabetic drugs. After optimizing basal insulin glargine during an 8-week run-in (mean HbA1c at baseline 7.9%), subjects were randomized 1:1 to mealtime faster aspart (n=345) or IAsp (n=344), each with insulin glargine and metformin. Bolus insulin was titrated using a simple, daily, patient-driven titration algorithm.

A Unique Case of Central Venous Sinus Thrombosis in Type 2 Diabetes with Severe Hypertriglyceridemia

We present a case of superior sagittal sinus thrombosis caused by uncontrolled type 2-diabetes and extremely high triglyceride. We believe this is the first report that demonstrates an association of CVST with uncontrolled type-2-diabetes and hypertriglyceridemia in an adult but in the absence of concomitant ketoacidosis, hyperosmolar state or any known pro-thrombotic conditions. Our case highlights the need for clinicians to consider CVST among patients with uncontrolled diabetes and hypertriglyceridemia. New diagnostic measures may become necessary which may also have an implication on the risk of recurrence and duration of anti-coagulant therapy in this group of patients.Bangladesh Crit Care J March 2016; 4 (1): 58-60

Implanted Muscle-Derived Stem Cells Ameliorate Erectile Dysfunction in a Rat Model of Type 2 Diabetes, but Their Repair Capacity Is Impaired by Their Prior Exposure to the Diabetic Milieu.

Muscle-derived stem cells (MDSCs) and other SCs implanted into the penile corpora cavernosa ameliorate erectile dysfunction in type 1 diabetic rat models by replenishing lost corporal smooth muscle cells (SMCs) and decreasing fibrosis. However, there are no conclusive data from models of type 2 diabetes (T2D) and obesity. To determine whether MDSCs from obese Zucker (OZ) rats with T2D at an early stage of diabetes (early diabetic SCs isolated and cultured in low-glucose medium [ED-SCs]) counteract corporal veno-occlusive dysfunction and corporal SMC loss or lipo-fibrosis when implanted in OZ rats at a late stage of diabetes and whether MDSCs from these OZ rats with late diabetes (late diabetic SCs isolated and cultured in high-glucose medium [LD-SC]) differ from ED-SCs in gene transcriptional phenotype and repair capacity. ED-SCs and LD-SCs were compared by DNA microarray assays, and ED-SCs were incubated invitro under high-glucose conditions (ED-HG-SC). These three MDSC types were injected into the corpora cavernosa of OZ rats with late diabetes (OZ/ED, OZ/LD, and OZ/ED-HG rats, respectively). Untreated OZ and non-diabetic lean Zucker rats functioned as controls. Two months later, rats were subjected to cavernosometry and the penile shaft and corporal tissues were subjected to histopathology and DNA microarray assays. In vivo erectile dysfunction assessment by Dynamic Infusion Cavernosometry followed by histopathology marker analysis of the penile tissues. Implanted ED-SCs and ED-HG-SCs improved corporal veno-occlusive dysfunction, counteracted corporal decreases in the ratio of SMCs to collagen and fat infiltration in rats with long-term T2D, and upregulated neuronal and endothelial nitric oxide. LD-SCs acquired an inflammatory, pro-fibrotic, oxidative, and dyslipidemic transcriptional phenotype and failed to repair the corporal tissue. MDSCs from pre-diabetic rats injected into the corpora cavernosa of rats with long-term T2D improve corporal veno-occlusive dysfunction and the underlying histopathology. In contrast, MDSCs from rats with long-term uncontrolled T2D are imprinted by the hyperglycemic and dyslipidemic milieu with a noxious phenotype associated with an impaired tissue repair capacity. SCs affected by diabetes could lack tissue repair efficacy as autografts and should be reprogrammed invitro or substituted by SCs from allogenic non-diabetic sources.

Perceptions of diabetes control among physicians and people with type 2 diabetes uncontrolled on basal insulin in Sweden, Switzerland, and the United Kingdom

Objective A large proportion of people with type 2 diabetes (T2D) remain uncontrolled on basal insulin. Yet, there is limited understanding of how people with uncontrolled type 2 diabetes (PWUD) perceive control and insulin intensification and whether their perceptions differ from those of physicians. The purpose of the study was to investigate perceptions of control and views on insulin intensification among physicians and PWUD.Research design and methods Web surveys of 1012 PWUD on basal insulin and 300 physicians were conducted in Sweden, Switzerland, and the United Kingdom.Results Analyses revealed significant differences between physicians and PWUD. Physicians were significantly more likely than PWUD to indicate that HbA1c (85.0% vs. 78.9%, p < 0.05), complications from diabetes (89.3% vs. 75.3%, p < 0.001), and frequency/severity of hypoglycemia (93.3% vs. 68.6%, p < 0.001) were very/extremely important for deciding whether or not diabetes is well controlled. In contrast PWUD were significantly more likely to place importance on a variety of factors, including energy levels (74.5% vs. 33.0%, p < 0.001), insulin units/day (77.6% vs. 29.0%, p < 0.001) and how predictable life is (72.1% vs. 29.3%, p < 0.001). PWUD also perceived significantly greater obstacles to control and viewed uncontrolled T2D as more interfering in their lives compared to physicians. Physicians were most reluctant to intensify insulin when there is a lack of patient agreement. Worries about weight gain and feelings of ‘getting sicker’ were the most frequently reported reasons why PWUD on basal insulin were reluctant to intensify insulin.Conclusions Results revealed a significant disconnect between physicians and PWUD in their perceptions of diabetes control. While physicians generally expressed a more focused and clinical view of diabetes control, patients had a broader view. Results also provide insights into PWUD and physicians’ reluctance to intensify insulin. The findings suggest that physician and patient education on differing perceptions could benefit communication and improve diabetes management.

Percepción de la insulinoterapia en pacientes con diabetes mellitus tipo 2 descontrolada

ObjectiveTo determine the perception of insulin therapy by patients with uncontrolled type2 diabetes mellitus, who have been treated with oral hypoglycaemic agents or insulin. DesignProspective comparative cross-sectional study. SettingFamily Medicine Unit No. 53 León, Guanajuato of Mexican Institute of Social Security. ParticipantsPatients between 40 and 80years old with uncontrolled type2 mellitus diabetes, treated with insulin or oral hypoglycaemic agents. Main measurementsPerception was assessed using the insulin treatment appraisal scale (ITAS). The rating of the survey is from 20 to 100 points, as such that when score increases the greater is the negative opinion. ResultsA sample of 459 diabetes patients were interviewed and split into 2 groups of patients according to their treatment. The OH group were patients treated with oral hypoglycaemic drugs only (56.9%), and the IN group were patients treated with insulin alone or combined with an oral hypoglycaemic (43.1%). Perception score was significantly higher in OH group (56.95±7.78 versus 49.55±8.89 points) than in the IN group (P<.001). ConclusionsThe perception of insulin therapy was worse in patients treated with only oral hypoglycaemic agents than in patients using insulin.

Exploring point-of-care transformation in diabetic care: A quality improvement approach

Objective This quality improvement project evaluated the impact of a point-of-care (POC) HbA1c stat lab intervention and a nurse-assisted expanded visit implemented among patients with uncontrolled type 2 diabetes (T2D) at a community health center in Houston, TX. Methods This was a before-and-after POC intervention among adult patients who received primary care services between 1 July 2014 and 31 December 2014 (baseline visit) and who had at least one 3-month follow-up visit. Results Three hundred eighty-seven patients were included in the study. The majority were 9%) at baseline, with the highest average levels among Hispanic (10.9%) and black (10.7%) patients. There was a significant difference in the HbA1c level before (mean=10.65, SD=1.9291) and after (mean=9.25, SD=1.8187) intervention. The absolute reduction in the level of HbA1c was 1.4% (t=12.834, p Conclusion There is a distinct advantage in using a stat HbA1c lab when combined with shared POC visits to assist patients with uncontrolled T2D in lowering the HbA1c, improving self-management, and reducing long-term costs.

Intermittent hypoxia is an independent marker of poorer glycaemic control in patients with uncontrolled type 2 diabetes

AimThis study investigated the association between intermittent hypoxia and glycaemic control in patients with uncontrolled type 2 diabetes (T2D) not treated for sleep apnoea. MethodsThis was a single-centre cross-sectional study of stable patients with T2D and HbA1c≥7% (53mmol/mol). Patients underwent overnight pulse oximetry and, if intermittent hypoxia—defined by a 4% oxyhaemoglobin desaturation index≥15—was observed, respiratory polygraphy was performed. All participants completed the Pittsburgh Sleep Questionnaire and Hospital Anxiety and Depression Scale. The association between intermittent hypoxia and poorer glycaemic control (defined by an HbA1c level above the median of 8.5%) was estimated by multivariate logistic regression analysis. ResultsOut of 145 patients studied, 54 (37.2%) had intermittent hypoxia (with sleep apnoea confirmed in 53). Patients with intermittent hypoxia had 0.7% (7.7mmol/mol) higher median HbA1c levels than patients without intermittent hypoxia (P=0.001). Intermittent hypoxia was associated with poorer glycaemic control after adjusting for obesity, age at onset and duration of diabetes, insulin requirement, sleep quality and depressive mood (OR: 2.31, 95% CI: 1.06–5.04, model adjusted for body mass index; OR: 2.46, 95% CI: 1.13–5.34, model adjusted for waist-to-height ratio). ConclusionIntermittent hypoxia, a consequence of sleep apnoea, is frequent and has a strong independent association with poorer glycaemic control in patients with uncontrolled T2D.