Type 2 Diabetes Mellitus Participants Research Articles

2213-PUB: Management Practices in Indian Type 2 Diabetes Mellitus (T2DM) Participants With or Without Comorbidities in Real-World LEADD (Learnings with Experts to Advance Diabetic Dyslipidemia Management) Study

Background: Diabetes is India’s major health concern due to its high disease burden. Objective: Evaluate management practices in Indian T2DM participants with/without co-morbidities and risk factors based on ADA/AACE guidelines. Methods: A real world, prospective, cross sectional, observational LEADD study in T2DM participants conducted at 226 sites. Participants with informed consent, were enrolled. Demographics, disease family history, comorbidities, lab data, and treatment as available was analyzed with descriptive statistics. “n” signifies number of participants analyzed for each parameter. Results: A total of 4002 participant’s records were evaluated. Mean age was 55.7 ± 11.5 years (n=3822), 52.5% males (n=1697/3230) and 66.5% had BMI of ≥25 kg/m2 (n=1868/2808). Average duration of T2DM was 7.6± 6.0 years (n = 2855) with mean values of Hb1Ac 8.15± 1.7% (n=2577), LDL 117.7±37.6mg/dl (n = 2545) and serum creatinine 1.34 ± 2.5 mEq/L (n= 2086). LDL-C levels (≥100mg/dl), 69.3% (n = 1764/2545), non-HDL C high (≥ 160mg/dl) in 42.6% (n= 1039/2438) was analyzed. Most common comorbidities were: Hypertension (68.3%, n = 1826/2673), dyslipidemia (52.3%, n = 1399/2673). Rosuvastatin was given in 87% (n=2419/2757) participants. Hb1Ac ≧7% was in 77.7% (n=2003/2577), blood pressure >140/90mmHg (n = 596/1826) in 32.6% participants. In ≥80% participants with ASCVD/ASCVD risk factors were not prescribed antihyperlipidemic drugs per recommendation by AACE/ADA guidelines. Conclusion: Significant participants with Diabetes had hypertension, hyperlipidemia as co-morbidities. T2DM participants have high ASCVD risk, many participants with co-morbidities were not optimally treated to goal. A need to strive for stringent control of Hb1Ac, hypertension and hyperlipidemia, as per AACE/ADA guidelines, is desired for better patient outcome. Disclosure A. Unnikrishnan: Other Relationship; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Dr. Reddys Laboratories, Eli Lilly and Company, Eris Pharmaceuticals, Ipca Laboratories Ltd., MSD, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi. A.K. Das: None. B.D. Saboo: None. S. Kalra: None. Funding Dr. Reddy's Laboratories; Diabetes Care India

617-P: Current Practices and Gaps in Management of Type 2 Diabetes Mellitus (T2DM) with Dyslipidemia as per American Diabetes Association (ADA) Guidelines Subset Analysis from LEADD (Learning with Experts to Advance Diabetic Dyslipidemia Management) Study

Background: CAD (Coronary Artery Disease) and diabetes is strongly associated with high low-density lipoproteins (LDL) levels. Objective: Understand evaluation practices and treatment for dyslipidemia with statin intensity in T2DM participants as per ADA guidelines. Methods: A subset analysis of real world, prospective, cross sectional, observational LEADD study in T2DM participants conducted at 226 sites. “n”=number of participants analyzed for each parameter. Available lipid profile was recorded and stratified based on age and Atherosclerotic cardiovascular disease (ASCVD) risk factors and ASCVD as per ADA guidelines for percentages achieving LDL-C target and high intensity of statin. Results: A total of 4002 participants enrolled with mean (±SD) Hb1Ac 8.15 ± 1.7%, LDL- C levels 117.7 ± 37.6 mg/dl. Rosuvastatin was given in 87% (n=2419/2757) participants. Participants <40 years, ASCVD risk factors and ASCVD were present in 95% (n=207/217) and 3.2% (n=7/217), in >40 years it was 86.7% (n=2908/3354) and 12.8% (n= 432/3354). Mean (±SD) LDL- C levels in ASCVD risk factors and ASCVD participants in <40 years was 129±37.9 mg/dl and 121±42mg/dl, in >40 years it was 120.9±36mg/dl and 118±41mg/dl. 64% (n= 155/162) and 80% (n= 4/5) participants <40 years with ASCVD risk factors and ASCVD, in >40 years 91.4% (n= 1925/2104) and 87.9% (278/316) were not on target LDL - C levels. In <40 years 15.6% (n = 22/141) and 83% (n = 5/6) statin receiving participants in the ASCVD risk factors and ASCVD group and in >40 years 87% (n = 1869/2143) and 77.8% (n = 271/348) were not receiving high intensity statins. Conclusion: Adherence to ADA guidelines for diabetic participants despite having ASCVD risk factors/ASCVD was sub-optimal in study participants, when high intensity statins is required for dyslipidemia to achieve desired outcomes in them. The findings need further research. Disclosure A. Unnikrishnan: Other Relationship; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Dr. Reddys Laboratories, Eli Lilly and Company, Eris Pharmaceuticals, Ipca Laboratories Ltd., MSD, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi. A.K. Das: None. B.D. Saboo: None. S. Kalra: None. V. Ayyar: None. M.H. Tiwaskar: None. Funding Diabetes Care India; Dr. Reddy's Laboratories

2249-PUB: Current Practices and Gaps in Management of Dyslipidemia in Indian Participants with Type 2 Diabetes Mellitus (T2DM) in Alignment with American Association of Clinical Endocrinologists (AACE) Guidelines in LEADD (Learning with Experts to Advance Diabetes

Background: Dyslipidemia is a common co-morbid condition in participants with T2DM. AACE guidelines advocate moderate to high intensity statins in T2DM unless contraindicated. Objective: Assess evaluation practices and treatment patterns for dyslipidemia with statin intensity usage in the T2DM population as per AACE guidelines. Methods: Sub-analysis of prospective, cross sectional, observational LEADD study in T2DM participants, conducted at 226 sites Participants stratified basis risk status and mean LDL was compared to recommended LDL levels as per AACE guidelines. “n”=number of participants analyzed for each parameter. Results: Total of 4002 participants were evaluated and had mean (±SD) LDL - C levels of 117.7 ± 37.66 mg/dl. AACE Risk stratification with available data (n = 3538/4002) of participants was conducted on stratification 0.3% (n = 11/3538) participants were in high risk, 87.0% (n = 3077/3538) in very high risk and 12.7% (450/3538) in extreme risk category. Mean(±SD) LDL - C was 116.8 (± 36.41), 118.1 (±38.04) and 118.4 (± 41.39) mg/dl as against goal of <100, <70 and <55mg/dl for high risk, very high risk and extreme risk groups. 77.5% (n = 1523/1964) participants evaluated for dyslipidemia received Rosuvastatin. Percentage participants not on LDL- C goal were 54.54%, 89.88% and 94.77% in high risk, very high risk and extreme risk. 87.44% (n = 1962/2244), and 77.69% (n = 282/363 in very high risk and extreme risk group did not receive moderate to high intensity statin as recommended by AACE. Conclusion: AACE guidelines adherence for evaluation and management of diabetic dyslipidemia is sub-optimal in study population. Although population falling in very high to extreme risk, they were not treated with moderate to high intensity statins. Reasons for these findings require further research. Disclosure A. Unnikrishnan: Other Relationship; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Dr. Reddys Laboratories, Eli Lilly and Company, Eris Pharmaceuticals, Ipca Laboratories Ltd., MSD, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi. A.K. Das: None. B.D. Saboo: None. S. Kalra: None. V. Ayyar: None. M.H. Tiwaskar: None. Funding Diabetes Care India; Dr. Reddy's Laboratories

Effects of SGLT2 inhibitors on fractures and bone mineral density in type 2 diabetes: An updated meta‐analysis

The aim of the study is to update and determine the effects of sodium glucose cotransporter 2 (SGLT2) inhibitor therapy on fracture and bone mineral density (BMD) in patients with type 2 diabetes mellitus (T2DM). We identified 27 eligible randomized controlled trials (RCTs) that compared the efficacy and safety of SGLT2 inhibitors to a placebo in 20895 T2DM participants, with an average duration of 64.22weeks. The relative risk (RR) of bone fracture and weighted mean difference (WMD) of changes in the BMD from baseline were determined to evaluate the risk of fracture. The degree of heterogeneity was evaluated by the I2 statistic, and publication bias was estimated using a funnel plot and Egger test. The pooled RR was 1.02 (95% CI [0.81, 1.28]) with low heterogeneity, indicating that SGLT2 inhibitor treatment was not correlated with a higher risk of fracture. Additionally, no increased risk was found for patients with different ages, sexes, and levels of HbA1c and some biochemical indicators. Three trials with 1303 patients reported a change in the BMD from baseline. SGLT2 inhibitor treatment did not decrease the BMD at four skeletal sites (lumbar spine, femoral neck, total hip, and distal forearm), and the overall WMD was 0.08 (95% CI [-0.09, 0.26]). No significant publication bias was detected. No increased risk for bone fracture was detected in patients with T2DM treated with SGLT2 inhibitors in this meta-analysis. SGLT2 inhibitor therapy did not appear to affect bone health, but more long-term detailed data are needed to validate this conclusion.

Elevated Resting and Postprandial Digestive Proteolytic Activity in Peripheral Blood of Individuals With Type-2 Diabetes Mellitus, With Uncontrolled Cleavage of Insulin Receptors

Objective: To examine resting and postprandial peripheral protease activity in healthy controls and individuals with type 2 diabetes mellitus (T2DM) and pre-T2DM.Methods: Individuals with T2DM or pre-T2DM and healthy controls (mean age 55.8 years) were studied before and for a span of 300 minutes following a single high-calorie McDonald’s breakfast. Metalloproteases-2/-9 (MMP-2/-9), elastase, and trypsin activities were assessed in whole blood before and following the meal using a novel high-precision electrophoretic platform. Also assessed were circulating levels of inflammatory biomarkers and insulin receptor density on peripheral blood mononuclear cells (PBMCs) in relationship to protease activity.Results: Premeal MMP-2/-9 and elastase activity levels in T2DM and in pre-T2DM participants were significantly elevated as compared to controls. The T2DM group showed a significant increase in elastase activity 15 minutes after the meal; elastase activity continued to increase to the 30-minute time point (p < 0.01). In control participants, MMP-2/-9, elastase, and trypsin were significantly increased at 15 minutes after the meal (p < 0.05) and returned to premeal values within a period of approximately 30 to 60 minutes post meal. PBMCs incubated for 1 hour with plasma from T2DM and pre-T2DM participants had significantly lower levels of insulin receptor density compared to those incubated with plasma from control participants (p < 0.001).Conclusions: The results of this study suggest that individuals with T2DM and pre-T2DM have higher resting systemic protease activity than nonsymptomatic controls. A single high-calorie/high-carbohydrate meal results in further elevations of protease activity in the systemic circulation of T2DM and pre-T2DM, as well as in healthy controls. The protease activity in turn can lead to a downregulation of insulin receptor density, potentially supporting a state of insulin resistance.

Metformin Improves Insulin Sensitivity and Vascular Health in Youth With Type 1 Diabetes Mellitus.

Cardiovascular disease is the leading cause of mortality in type 1 diabetes mellitus (T1DM) and relates strongly to insulin resistance (IR). Lean and obese adolescents with T1DM have marked IR. Metformin improves surrogate markers of IR in T1DM, but its effect on directly measured IR and vascular health in youth with T1DM is unclear. We hypothesized that adolescents with T1DM have impaired vascular function and that metformin improves this IR and vascular dysfunction. Adolescents with T1DM and control participants underwent magnetic resonance imaging of the ascending (AA) and descending aorta to assess pulse wave velocity, relative area change, and maximal (WSSMAX) and time-averaged (WSSTA) wall shear stress. Participants with T1DM also underwent assessment of carotid intima-media thickness by ultrasound, brachial distensibility by DynaPulse, fat and lean mass by dual-energy x-ray absorptiometry, fasting laboratories after overnight glycemic control, and insulin sensitivity by hyperinsulinemic-euglycemic clamp (glucose infusion rate/insulin). Adolescents with T1DM were randomized 1:1 to 3 months of 2000 mg metformin or placebo daily, after which baseline measures were repeated. Forty-eight adolescents with T1DM who were 12 to 21 years of age (40% body mass index [BMI] ≥90th percentile; 56% female) and 24 nondiabetic control participants of similar age, BMI, and sex distribution were enrolled. Adolescents with T1DM demonstrated impaired aortic health compared with control participants, including elevated AA and descending aorta pulse wave velocity, reduced AA and descending aorta relative area change, and elevated AA and descending aorta WSSMAX and WSSTA. Adolescents with T1DM in the metformin versus placebo group had improved glucose infusion rate/insulin (12.2±3.2 [mg·kg-1·min-1]/μIU/μL versus -2.4±3.6 [mg·kg-1·min-1]/μIU/μL, P=0.005; 18.6±4.8 [mg·lean kg-1·min-1]/μIU/μL versus -3.4±5.6 [mg·lean kg-1·min-1]/μIU/μL, P=0.005) and reduced weight (-0.5±0.5 kg versus 1.6±0.5 kg; P=0.004), BMI (-0.2±0.15 kg/m2 versus 0.4±0.15 kg/m2; P=0.005), and fat mass (-0.7±0.3 kg versus 0.6±0.4 kg; P=0.01). Glucose infusion rate/insulin also improved in normal-weight participants (11.8±4.4 [mg·kg-1·min-1]/μIU/μL versus -4.5±4.4 [mg·kg-1·min-1]/μIU/μL, P=0.02; 17.6±6.7 [mg·lean kg-1·min-1]/μIU/μL versus -7.0±6.7 [mg·lean kg-1·min-1]/μIU/μL, P=0.02). The metformin group had reduced AA WSSMAX (-0.3±0.4 dyne/cm2 versus 1.5±0.5 dyne/cm2; P=0.03), AA pulse wave velocity (-1.1±1.20 m/s versus 4.1±1.6 m/s; P=0.04), and far-wall diastolic carotid intima-media thickness (-0.04±0.01 mm versus -0.00±0.01 mm; P=0.049) versus placebo. Adolescents with T1DM demonstrate IR and impaired vascular health compared with control participants. Metformin improves IR, regardless of baseline BMI, and BMI, weight, fat mass, insulin dose, and aortic and carotid health in adolescents with T1DM. Metformin may hold promise as a cardioprotective intervention in T1DM. URL: https://www.clinicaltrials.gov . Unique identifier: NCT01808690.

Factors Associated With Presenteeism at Work in Type 2 Diabetes Mellitus.

Our study aimed to identify factors associated with decreased presenteeism in type 2 diabetes mellitus (T2DM). Data were collected from 147 T2DM participants. Questionnaires were completed: Stanford Presenteeism Scale (SPS-6) assessing health status and employee productivity, Hospital Anxiety and Depression Scale (HADS) for mental health, SF-36 for quality of life, Problem Areas in Diabetes (PAID) to measure diabetes-related emotional distress, and Michigan Neuropathy Screening Instrument for diabetic neuropathy. PAID score was negatively related to the SPS-6 score (r = -0.527, P < 0.001). Both anxiety and depression were negatively correlated with SPS-6 (r = -0.377, P < 0.001 and r = -0.603, P < 0.001, respectively). Seven out of eight different categories of SF-36 were significantly associated with SPS-6 score. Neuropathy was negatively related to presenteeism (r = -0.228, P = 0.07). Factors related to decreased presenteeism in T2DM include diabetes-associated stress, poor mental health, poor quality of life, and a history of neuropathy.

Dietary vitamin and mineral intakes in a sample of pregnant women with either gestational diabetes or type 1 diabetes mellitus, assessed in comparison with Polish nutritional guidelines.

Maintaining proper nutrition during pregnancy is crucial for pregnant women and especially for who have been diagnosed with type 1 diabetes mellitus (T1DM) or who develop gestational diabetes mellitus (GDM). To measure differences in vitamin and mineral intakes among women with normal pregnancies, pregnant women with GDM, and pregnant women with pre-gestational T1DM; and to assess the women's dietary intakes in comparison with Polish nutritional guidelines. The analysis was conducted among 83 pregnant women (29 GDM patients, 26 T1DM patients and 28 normal pregnancy participants) from whom we collected seven-day 24-hour dietary records during the second part of their pregnancies. There were no statistically significant differences observed for most of the vitamin and mineral intakes across the three groups. However, we did observe a significant difference in the vitamin C and calcium intakes between groups. The mean vitamin C and calcium intakes were significantly higher in the control group than among the diabetic patients. Insufficient dietary calcium intakes were found among 52.3% of the GDM patients and 61.6% of the T1DM participants, while only 28.6% of the normal pregnancy patients experienced a calcium deficiency. The highest incidence of inadequate intake in each of the GDM, T1DM and control groups was observed for vitamin D (100%, 100%, 100%), folate (97.7%, 100%, 100%), iron (97.7%, 100%, 100%), and iodine (97.7%, 92.4%, 85.7%), respectively. Diet alone may not be enough to provide adequate levels of vitamins and minerals for most micronutrients. Supplement use reduces the risk of inadequate intake for many micronutrients, but diet-related issues during pregnancy and pregnancy diagnosed with diabetes remain, and they deserve to be addressed during public health interventions.

Unmet Needs in the Management of Type 2 Diabetes Mellitus Patients Starting Insulin Therapy with Basal or Premix Insulin in Routine Clinical Practice in Serbia.

IntroductionType 2 diabetes mellitus (T2DM) is a progressive disease with declining beta cell function, ultimately necessitating insulin therapy. Timely introduction of adequate insulin improves management of diabetes. The aim of this study was to evaluate the unmet needs in the management of T2DM patients recently initiated on insulin therapy in routine clinical practice in Serbia.MethodsThe NEED study was a cross-sectional, observational, multicenter, real-world study conducted in Serbia, involving 26 physicians, endocrinologists, treating individuals with T2DM from 17 secondary health care institutions. Study participants were newly initiated with insulin therapy, being treated with basal or premix insulin ± oral antidiabetics (OAD) for 6–12 months.ResultsFour hundred one individuals were included in the study between October 2016 and March 2017. The mean age of study patients was 61.8 ± 9.2 years with mean BMI 30.0 ± 5.0 kg/m2, and duration of diabetes, prior to initiation of insulin therapy, was 8.4 ± 5.9 years. A basal insulin regimen was used by 287 (71.6%) and premix insulin by 114 (28.4%) subjects. The average daily dose (39.8 ± 13.9 units premix vs. 26.3 ± 13.5 units basal), dose/kg (0.47 ± 0.15 units/kg premix vs. 0.31 ± 0.17 units/kg basal), and number of injections per day were higher in the premix compared with basal insulin regimen (p < 0.01). The percentage of T2DM participants with at least one unmet need was high (95.8%). The majority of participants had two or three unmet needs. The most common unmet needs were: HbA1c > 7.0% (79.3%), at least one documented symptomatic hypoglycemia (≤ 3.9 mmol/l) event in the previous 3 months (63.8%), and two or more doses of insulin per day (53.1%). The mean individual HbA1c target was 6.8% in the NEED study cohort, with only 16% of participants reaching it. Most participants [281 (70.1%)] experienced symptomatic hypoglycemia.ConclusionsThe NEED study showed that new insulin users of either basal or premix HM insulin have many unmet needs in the first 6–12 months of treatment. This confirms that in real-life settings novel insulins should be considered in the management of T2DM to reduce the number of symptomatic hypoglycemic events and reach a better HbA1c level.FundingSanofi, Serbia.

Risk of progressive chronic kidney disease in individuals with early-onset type 2 diabetes: a prospective cohort study

The progression trajectory of renal filtration function has not been well characterized in patients with early-onset type 2 diabetes mellitus (T2DM) although albuminuria is often reported in this population. We aim to study the risk of progressive chronic kidney disease (CKD) in individuals with early-onset T2DM. In total, 1189 T2DM participants were followed for 3.9 (interquartile range 3.2-4.7) years. Progressive CKD was defined as estimated glomerular filtration rate (eGFR) decline of ≥5 mL/min/1.73 m2 per year. Early-onset T2DM was defined as age at T2DM diagnosis between 18 and 30 years. Compared with later-onset counterparts (N = 1032), participants with early-onset T2DM (N = 157) were more obese and had poorer glycaemic control at baseline. In the follow-up, 24.2% and 15.6% experienced progressive CKD in early-onset and later-onset participants, respectively (P = 0.007). Logistic regression suggested that participants with early-onset T2DM had 2.63-fold [95% confidence interval (CI) 1.46-4.75] higher risk of progressive CKD after accounting for multiple traditional risk factors. Furthermore, the excess risk of progressive CKD associated with early-onset T2DM mainly occurred in participants with preserved renal function [eGFR ≥60 mL/min/1.73 m2, odds ratio (OR) 2.85, 95% CI 1.50-5.42] and was more pronounced in those with diabetes duration <10 years (OR 3.67, 95% CI 1.51-8.90). Individuals with early-onset T2DM have a higher risk of progressive CKD. The excess risk mainly exhibits in early stage of CKD and cannot be solely attributed to traditional risk factors and a longer diabetes duration.

Impact of Glycaemic Control on Bone Metabolism in Adult Patients with Type 1 Diabetes Mellitus

Introduction: Type 1 diabetes mellitus (T1DM) is associated with reduced bone mineral density (BMD), increased bone turnover and impaired bone microarchitecture. However, data regarding the influence of glycaemic control on bone metabolism are limited. The aim of this study was to evaluate BMD and bone remodeling markers in patients with T1DM in relation to changes in glycaemic control. Methods/Design: We studied 118 patients with T1DM and age 20-50 years (mean 34.6±7.9years, M/F:53/65), diabetes duration &amp;gt;5 years and no diabetic complications and 95 healthy controls matched for age, sex and body mass index (BMI). All T1DM participants were re-examined after one-year (FU). In both groups, measurements of glycated hemoglobin (HbA1c) and BMD at lumbar spine (LS) and femoral neck (FN) by dual energy X-ray absorptiometry (DXA) were performed. Bone resorption and formation was assessed by measurements of β-crosslaps and of type 1 procollagen total N-terminal propeptide (TP1NP) in serum. Currently, seventy T1DM patients completed the FU and had repeat biochemical and BMD measurements. Based on current literature, BMD changes of ≥3% at the LS and of ≥6% at the FN were considered significant. Results: In the T1DM group, mean duration of the disease was 15.9±7.6 years and mean HbA1c was 8.1±1.4%. Subject in the T1DM group had lower BMD and Z-score at LS and FN compared to those in the control group (LS:p=0.039,p=0.02) (FN:p=0.041,p=0.038). At baseline, no significant differences in β-crosslaps and TP1NP were observed between the two groups. Out of the 70 T1DM patient who have completed FU so far, 42/70 patients had ≥0.5% reduction in HbA1c, 12/70 had about the same HbA1c (±0.4%) and 16/70 had ≥0.5% increase in HbA1c. In the 42 patients with improved HbA1c, BMD increased by 3.4% at the LS and by 5.7% at the FN, and TP1NP was significantly higher compared to baseline (p=0.043). Conclusion: T1DM is associated with reduced BMD but improvement of glycaemic control appears to ameliorate BMD and bone turnover. Disclosure E. Barmpa: None. M. Vlychou: None. S. Tigas: None. G.N. Koukoulis: None. A. Bargiota: None.

Cardiometabolic Disease Risk Assessment Predicts Incident Diabetes in a Large and Diverse Population

Background: Risk scores for predicting type-2 diabetes mellitus (T2DM) have been developed, but few have included adequate African-Americans. Objective: To derive and validate scoring systems to predict future diabetes in populations including caucasian- and African-Americans, weighted by sex and race. Design, Setting, and Participants: We estimated 9.5-year risk of T2DM in participants with valid follow-up data taken from 12,1321 people in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, and externally validated it in 9,712 participants from the Atherosclerosis Risk in Communities study. Methods: Cardiometabolic disease scores were calculated for each sex-race pair using quantitative clinical data. Incidence diabetes was defined as fasting glucose ≥ 126 mg/dL, non-fasting glucose ≥ 200mg/dL, currently on medication for T2DM, or self-report. Covariates included: sex, race, and age; waist circumference; blood pressure; HDL cholesterol; fasting triglycerides or on lipid-lowering medication. We assigned a simple integer score for each risk factor component using logistic regression coefficients for each sex-race pair. Discrimination was assessed with area under the receiver operating characteristic curves (AROCs). Results: Diabetes incidence rates at a median follow-up of 9.5 years were 18.3% and 18.7% in African-American men and women, and 12.3% and 9.2% in caucasian-American men and women. Weighted covariates differed more by race than sex (p = 0.001). The AROCs ranged from 0.72 for black men to 0.78 for white women. Externally validated models performed well; AROC was 0.75 (black men) to 0.83 (white women). Conclusion: The weighted CMDS score has high model discrimination using readily available clinical data, and can be used to quantify T2DM risk based on race- and sex- specific data; thus, diabetes prevention can be targeted to high risk individuals in a manner that optimizes outcomes, benefit/risk ratio, and cost-effectiveness. Disclosure L. Wilkinson: None. T. Mehta: Employee; Spouse/Partner; Becton, Dickinson and Company. Consultant; Self; NuTech Medical. W. Garvey: Advisory Panel; Self; Novo Nordisk Inc., Merck &amp; Co., Inc.. Research Support; Self; Sanofi, Pfizer Inc., Novo Nordisk Inc., AstraZeneca, Merck &amp; Co., Inc., Elcelyx Therapeutics, Inc., Lexicon Pharmaceuticals, Inc., Eisai Inc..

Fluid Intake Habits in Type 1 Diabetes Individuals during Typical Training Bouts

Background/Aims: Hyperglycemia may influence the hydration status in diabetic individuals. During exercise, type 1 diabetes mellitus (T1DM) individuals may be challenged by a higher risk of dehydration due to a combination of fluid losses from sweat and increased urine output via glycosuria. So far, no study has characterised spontaneous fluid intake in T1DM individuals during active trainings. Methods: A validated questionnaire was used to assess T1DM participants’ diabetes therapy, sports characteristics and fluid intake during training; results were then compared to an age- and sport-matched sample of non-diabetic individuals. Results: Ninety individuals completed the survey (n = 45 T1DM individuals, n = 45 matched controls). A proportion of T1DM ­individuals reported blood glucose levels greater than 10.0 mmol at both the start (28.9%) and end (24.4%) of the exercise. The mean self-reported fluid intake was greater in T1DM (0.60 ± 0.47 L·h^–1) compared to that of the control (0.37 ± 0.28 L·h^–1, p < 0.05). In spite of drinking fluid volumes in line with international guidelines, 84.4% of those with T1DM reported that they were still feeling thirsty at the end of their training session. Conclusions: T1DM individuals self-report spontaneously consuming fluid adequate volumes suggested by sport nutrition guidelines for non-diabetic athletes. Discrepancies in the T1DM subjectively reported feelings of thirst suggest that more education on hydration during exercise is needed for this population to adequately compensate for elevated blood glucose levels. It remains to be established whether fluid volumes suggested for healthy athletes are adequate for maintaining euhydration in T1DM patients due to their altered diuresis.

CPR-IR is an insulin resistance index that is minimally affected by hepatic insulin clearance-A preliminary research.

BackgroundIncreased hepatic insulin clearance (HIC) is important in the pathophysiology of type 2 diabetes mellitus (T2DM). The aim of this study is to analyze an effective insulin resistance (IR) index that is minimally affected by HIC.MethodsOur study involved 20 participants with T2DM and 21 healthy participants without diabetes (Non-DM). Participants underwent a meal tolerance test from which plasma glucose, insulin and serum C-peptide immunoreactivity (CPR) were measured, and HOMA-IR and HIC were calculated. Participants then underwent a hyperinsulinemic-euglycemic clamp from which the glucose disposal rate (GDR) was measured.ResultsThe index CPR-IR = 20/(fasting CPR × fasting plasma glucose) was correlated more strongly with GDR, than was HOMA-IR, and CPR-IR could be used to estimate GDR. In T2DM participants with HIC below the median, HOMA-IR and CPR-IR were equally well correlated with GDR. In T2DM with high HIC, CPR-IR correlated with GDR while HOMA-IR did not. In Non-DM, CPR-IR and HOMA-IR were equally well correlated with GDR regardless of HIC. The mean HIC value in T2DM was significantly higher than that of Non-DM.ConclusionsCPR-IR could be a simple and effective index of insulin resistance for patients with type 2 diabetes that is minimally affected by HIC.

Metabolite changes in risk of type 2 diabetes mellitus in cohort studies: A systematic review and meta-analysis

AimsFasting plasma glucose, oral glucose tolerance test, and glycated hemoglobin are diagnostic markers for type 2 diabetes mellitus (T2DM). However, it is necessary to detect physiological changes in T2DM rapidly and stratify diabetic stage using other biomarkers. We performed a systematic review and meta-analysis to contribute to the development of objective and sensitive diagnostic indicators by integrating metabolite biomarkers derived from large-scale cohort studies. MethodsWe searched for metabolomics studies of T2DM cohort in PubMed, Scopus, and Web of Science for studies published within the last 10 years from January 2008 to February 2017. The concentrations of metabolites and odds ratios (ORs) were integrated and risk ratio (RR) values were estimated to distinguish subjects with T2DM and normal participants. ResultsFourteen cohort studies were investigated in this meta-analysis. There were 4592 patients in the case group and 11,492 participants in the control group. We noted a 1.89-, 1.63-, and 1.87-fold higher risk of T2DM associated with leucine (RR 1.89 [95% CI 1.57–2.29]), alanine (RR 1.63 [95% CI 1.48–1.79]), and oleic acid (RR 1.87 [95% CI 1.62–2.17]), respectively. Lysophosphatidylcholine C18:0 (RR 0.80 [95% CI 0.72–0.90]) and creatinine (RR 0.63 [95% CI 0.53–0.74]) were associated with 20% and 37% decreased T2DM risks, respectively. ConclusionsMost amino acids in patients were positively related to diabetes, while creatinine and some lysophosphatidylcholines showed a negative relationship. This suggests that diabetic risk prediction using metabolites that sensitively reflect changes in the body will improve individual diagnosis and personalize medicine.

Exercise capacity in diabetes mellitus is predicted by activity status and cardiac size rather than cardiac function: a case control study

BackgroundThe reasons for reduced exercise capacity in diabetes mellitus (DM) remains incompletely understood, although diastolic dysfunction and diabetic cardiomyopathy are often favored explanations. However, there is a paucity of literature detailing cardiac function and reserve during incremental exercise to evaluate its significance and contribution. We sought to determine associations between comprehensive measures of cardiac function during exercise and maximal oxygen consumption (dot{V}O_{2}peak), with the hypothesis that the reduction in exercise capacity and cardiac function would be associated with co-morbidities and sedentary behavior rather than diabetes itself.MethodsThis case–control study involved 60 subjects [20 with type 1 DM (T1DM), 20 T2DM, and 10 healthy controls age/sex-matched to each diabetes subtype] performing cardiopulmonary exercise testing and bicycle ergometer echocardiography studies. Measures of biventricular function were assessed during incremental exercise to maximal intensity.ResultsT2DM subjects were middle-aged (52 ± 11 years) with a mean T2DM diagnosis of 12 ± 7 years and modest glycemic control (HbA1c 57 ± 12 mmol/mol). T1DM participants were younger (35 ± 8 years), with a 19 ± 10 year history of T1DM and suboptimal glycemic control (HbA1c 65 ± 16 mmol/mol). Participants with T2DM were heavier than their controls (body mass index 29.3 ± 3.4 kg/m2 vs. 24.7 ± 2.9, P = 0.001), performed less exercise (10 ± 12 vs. 28 ± 30 MET hours/week, P = 0.031) and had lower exercise capacity (dot{V}O_{2}peak = 26 ± 6 vs. 38 ± 8 ml/min/kg, P < 0.0001). These differences were not associated with biventricular systolic or left ventricular (LV) diastolic dysfunction at rest or during exercise. There was no difference in weight, exercise participation or dot{V}O_{2}peak in T1DM subjects as compared to their controls. After accounting for age, sex and body surface area in a multivariate analysis, significant positive predictors of dot{V}O_{2}peak were cardiac size (LV end-diastolic volume, LVEDV) and estimated MET-hours, while T2DM was a negative predictor. These combined factors accounted for 80% of the variance in dot{V}O_{2}peak (P < 0.0001).ConclusionsExercise capacity is reduced in T2DM subjects relative to matched controls, whereas exercise capacity is preserved in T1DM. There was no evidence of sub-clinical cardiac dysfunction but, rather, there was an association between impaired exercise capacity, small LV volumes and sedentary behavior.

Comparative usability study of the dulaglutide single-use pen versus the insulin degludec FlexTouch® among self-injection-naïve patients with type 2 diabetes mellitus in Japan

Objective: This study assessed training time with the dulaglutide single-use pen (SUP) and the insulin degludec disposable prefilled pen (FlexTouch®) in self-injection–naïve patients with type 2 diabetes mellitus (T2DM) in Japan.Methods: This multi-center, open-label, comparative, crossover study measured training time with the dulaglutide SUP vs FlexTouch®. Participants learned how to use both devices in a randomly assigned order. Healthcare providers (HCP) conducted the training. The primary end-point was the time required to train self-injection-naïve T2DM participants to self-inject correctly using each device. Secondary end-points included performance measures, such as success and error rates, patient perceptions related to ease-of-use, and factors associated with training time and performance.Results: Overall, 48 participants were randomized and completed the study. The mean training time to achieve correct administration was significantly shorter with the dulaglutide SUP vs FlexTouch® (7.4 min vs 19.7 min, p < .001). The proportions of participants who successfully completed the mock injection without error were similar for both devices. Ninety-two percent (44/48) of participants reported that the dulaglutide SUP was easier to use than FlexTouch®.Conclusions: In this study, participants required a shorter training time to achieve correct administration with the dulaglutide SUP, and had a higher preference for the dulaglutide SUP, when compared to FlexTouch®. These data suggest that the dulaglutide SUP is easy-to-use, which may decrease the burden on HCPs to train diabetic patients how to administer injection therapy and reduce patient injection hurdles, such as needle fear.

Appraising risk of development of cardiovascular disease in patients with type 2 diabetes mellitus

Background: Research shows a strong relationship between type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). Most commonly, diabetic participants experience increased morbidity and mortality due to CVD complications. This study aims to determine the proportion of CVD prevalence and to evaluate the risk factors for developing CVD among T2DM participants and to evaluate the CVD risk factor for the next 10 years using Joint British Societies recommendations on the the Prevention of Cardiovascular Disease (JBS3) scale. Materials and Methods: In this hospital-based observational study, data including serum creatinine, blood urea, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very LDL, echocardiography, and ECHO readings were collected from a random sample of 106 participants, both diabetic and nondiabetic. The risk of developing CVD in participants with DM in the next 10 years was evaluated using the JBS3 risk calculator through analysis of collected data. Results: Among 106 participants, there were 72 participants with DM, and the majority of these participants had comorbidities, including hypertension and other CVDs. According to the data collected from DM participants, it was observed that 77.77% had elevated serum creatinine value, 27.77% had elevated blood urea level, 61.11% had abnormal HDL value, 65.27% had elevated LDL value, and 26.38% had elevated VLDL value. Total triglycerides level was also observed to be high in 54.16% of the DM participants. Moreover, the results indicated that CVD was present in 77.78% of type 2 diabetic patients, which was comparatively higher than in nondiabetic participants of whom 32.35% had CVD. Conclusion: Based on the data collected and results obtained from the JBS3 risk calculator, it was found that the participants with DM were at higher risk of developing CVD.

The resting perfusion pattern associates with functional decline in type 2 diabetes

We investigated the relationships between cerebral blood flow (CBF), cognitive, and mobility decline in type 2 diabetes mellitus (T2DM) over a 2-year period. Seventy-three participants (41 T2DM and 32 controls) were evaluated using volumetric CBF with arterial spin labeling perfusion magnetic resonance imaging at baseline and at the 2-year follow-up. Regions with significant CBF differences between T2DM participants and controls at baseline were detected using voxel-wise analysis. Correlation analysis was performed to investigate the association between regional CBF and cognitive or mobility performance over the 2-year span. Compared to controls, participants with T2DM had decreased CBF in the resting-state default mode, visual, and cerebellum networks. Greater decrease in longitudinal CBF values at these regions over a 2-year span was associated with worse gait, memory and executive functions, and higher baseline insulin resistance and worse baseline cognitive performance. In T2DM, impairment of resting regional perfusion is closely related to worse cognitive and mobility performance. Insulin resistance may further contribute to regional perfusion deficit in T2DM.

A study on the prevalence of risk factors and presence of diabetic foot ulcers in T2DM patients in K. R. Hospital, Mysuru

Background: India is one of the top ten diabetes mellitus (DM) countries. Thus, the aim of this study was to survey the prevalence of DFU risk factors and DFU prevalence among type 2 diabetes mellitus (T2DM) patients.Methods: An epidemiological study was conducted on an outpatient basis in K. R. hospital, Mysuru. All T2DM participants were ≥ 18 years were included. Demographic and foot care behavior were assessed using minimum data sheet (MDS). Meanwhile, presence of risk factors was evaluated for neuropathy and presence of angiopathy was evaluated with ankle brachial index (ABI) by using a hand-held doppler both dorsal and posterior tibial.Results: At the end of study, 249 T2DM participants were enrolled. The prevalence of DFU risk factors was 55.4% (95% CI: 53.7% - 57.0%), and prevalence of DFU was 12% (95% CI: 10.3% - 13.6%).Conclusions: Even though the prevalence of DFU is high, identification associated factors for presence of risk and DFU has not been integrated into national guideline. Thus, preventive strategies should be introduced at early stage to prevent presence of risk and DFU.