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Type 2 Diabetes clinical trials

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NCT ID: NCT02931630 Completed - Type 2 Diabetes Clinical Trials

The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health

MERITS
Start date: May 2016
Phase: N/A
Study type: Interventional

The prevalence of overweight and lifestyle related diseases such as cardiovascular disease (CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D. Dietary fibers and whey protein have independently shown beneficial effects on several of these risk factors in previous studies. Whey protein is furthermore seen to show positive effects on bone turnover. The purpose of this trial is to investigate whether an increased intake of dietary fibers and whey protein (separately or combined) over a period of 12 weeks will affect the risk markers of MeS and bone turnover in abdominally obese subjects. A total of 80 people with abdominal obesity will be included. The design is a randomized, double blinded, controlled dietary intervention trial. Subjects are assigned to one of four experimental groups. Each group are provided with test products containing either high or low whey protein and high or low dietary fibers to replace part of their regular diet. The subjects are instructed in how to incorporate the test products in their habitual diets in order to maintain weight stability. The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of developing CVD. PPL is estimated by performing a standardized high fat meal test during which postprandial level of triglycerides is measured. The authors hypothesize that a diet of high content of whey protein and high dietary fiber during 12 weeks will induce a reduction in PPL.

NCT ID: NCT02917057 Completed - Type 2 Diabetes Clinical Trials

Subanalyses of Elderly Type 2 Diabetes Patients or Type 2 Diabetes Patients With Renal Impairment

Start date: August 1, 2015
Phase:
Study type: Observational

Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages, such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes in customary clinical care in patients with mild and moderate renal impairment and in elderly patients are unknown. The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative to basal insulin initiated as first-ever injectable therapeutic regimens among elderly patients and patients with renal impairment. Patients who initiated treatment with Bydureon or basal insulin between July 2011 and March 2015 will be recruited into the study cohorts from Optum's database of electronic health records. The two treatment cohorts will be matched by propensity score method. Changes in HbA1c, weight, markers for renal function (estimated glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR)), and incidences of gastrointestinal symptoms and hypoglycaemia are investigated for patients with different eGFR categories and with different ages.

NCT ID: NCT02914691 Completed - Type 2 Diabetes Clinical Trials

Effects of Dapagliflozin Treatment on Urinary Proteomic Patterns in Patients With Type 2 Diabetes

DapKid
Start date: August 2015
Phase: Phase 4
Study type: Interventional

Background: SGLT2 inhibitors are the first antiglycaemic drugs with a direct renal action. A part from reducing blood glucose, systemic blood pressure and albuminuria are decreased, while natriuresis is increased. Previous research into urinary peptide patterns (proteomics) has revealed that patients in risk of progressive renal disease display a "risk peptide pattern" in their urine, ahead of decline in renal function. Furthermore a urinary proteome pattern is related to CVD risk. The long-term impact of dapagliflozin (dapa) treatment on renal parameters is unknown, but long term randomized trials are ongoing. By investigating the impact of dapa treatment on this peptide pattern, it will be determined whether this intervention can improve the urinary proteomic peptide pattern. In addition new knowledge regarding renal processes that the treatment influences is sought. The impact of treatment of urinary and tubular markers of oxidative stress and function (metabolomics) will be assessed. These markers are thought to represent one of several deleterious pathways involved in the pathology of diabetic renal disease, and here the impact dapa treatment will be investigated. Improvement of these markers of oxidative stress may indicate long-term benefit. Objective: The primary objective is to assess the impact of three months of treatment with dapa 10 mg once daily or placebo on renal proteomics pattern and other risk markers of diabetic comorbidity. Design: Double blinded, randomized, placebo-controlled crossover, single center study. Treatment period: 2 x 12 weeks. Patient population: 40 patients with type 2 diabetes recruited from Steno Diabetes Center in accordance with the study in- and exclusion criteria. Intervention: Dapa 10 mg daily vs. placebo. Endpoints: Primary outcome: To evaluate the effect of dapa treatment on urinary proteomic patterns in patients with type 2 diabetes, microalbuminuria and eGFR equal to or above 45 ml/min/1.73m2. Secondary endpoints are the effect of the intervention on other markers for tubular function, inflammation, endothelial dysfunction, microcirculation, kidney function, albuminuria, vasoactive hormones in plasma, and effect on global longitudinal strain as measured by echocardiography. Timeframe: Randomisation planned from June 2015, inclusion over the following 9 months. Last patient is expected to be completed October 2016. Data analysis completed December 2016, presentation autumn 2017 and publication early 2018.

NCT ID: NCT02913703 Completed - Type 2 Diabetes Clinical Trials

Preprandial Ghrelin Effect

Start date: January 11, 2017
Phase: Phase 1
Study type: Interventional

Background and Significance: The peptide hormone ghrelin drives hunger and feeding behavior, making it a focus of obesity research. Released mainly by the stomach and proximal small intestine, ghrelin peaks prior to meals, potentially priming the gut for anticipated nutrients. After eating, ghrelin abruptly declines, with levels varying 2- to 3-fold between the fasted and fed states. Interestingly, in obesity and type 2 diabetes (T2D), this pattern is disrupted. Individuals with these disorders have chronically suppressed ghrelin levels and little variation before and after meals. Although ghrelin's preprandial rise and postprandial fall is a well-established phenomenon, its role in regulating glucose metabolism is unclear. In mice, increasing preprandial ghrelin levels improves glucose tolerance through enhanced glucagon-like peptide-1 (GLP-1) secretion. Ghrelin also stimulates GLP-1 secretion from mouse and human intestinal L-cells in vitro. These findings suggest enhanced postprandial GLP-1 as a novel role for the preprandial ghrelin surge. A ghrelin-incretin enteroendocrine axis could also explain the poor postprandial GLP-1 secretion and glucose tolerance in subjects with T2D, given their preprandial hypoghrelinemia. The investigators' preliminary data demonstrate that in humans, increasing circulating ghrelin to a supraphysiologic range worsened glucose tolerance, despite increased GLP-1 secretion. The discrepancy between these findings and the ones from rodents could be due to difference in study design and/or species. For example, the investigators' study used a continuous ghrelin infusion, which resulted in elevated levels of ghrelin pre- and postprandially. Elevated postprandial ghrelin likely mitigated the positive effects of increased GLP-1 secretion by raising levels of glucagon and other counter-regulatory hormones. This study seeks to delineate the interactions between ghrelin and GLP-1 in the regulation of glucose tolerance, beta-cell function, and insulin sensitivity. The investigators hypothesize that increased preprandial ghrelin will enhance GLP-1 secretion and consequently improve glucose tolerance in healthy subjects and those with T2D. Confirmation of these hypotheses would advance the investigators understanding of the control of glucose homeostasis and have important clinical and therapeutic implications. Modulating ghrelin levels may provide a novel therapeutic strategy to improve glucose tolerance in individuals with T2D, which affects an estimated 350 million people worldwide.

NCT ID: NCT02908152 Completed - Type 2 Diabetes Clinical Trials

Curcumin Supplement in Nonalcoholic Fatty Liver Patients

Start date: February 10, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate the effects of curcumin supplement on metabolic factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes. Subjects will participate in 3 month, two group, randomized intervention, where one group (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare differences in outcomes between the two groups.

NCT ID: NCT02895867 Completed - Type 2 Diabetes Clinical Trials

Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes

Start date: May 2016
Phase: N/A
Study type: Interventional

This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.

NCT ID: NCT02889510 Completed - Type 2 Diabetes Clinical Trials

Study to Assess the Efficacy of Liraglutide in Patients With Type 2 Diabetes Mellitus

Start date: October 4, 2016
Phase: Phase 3
Study type: Interventional

Type 2 diabetes (T2DM) is related to reduced pulmonary function. As experimental studies with glucagon-like peptide 1 (GLP-1) have shown an increase in pulmonary surfactant secretion, and the GLP-1 receptor has been found in significant amounts in the lung, it could be hypothesized that the treatment with liraglutide (a GL-1 agonist) will improve this reduced pulmonary function

NCT ID: NCT02887898 Completed - Type 2 Diabetes Clinical Trials

Efficacy of Automated Bolus Calculation in Type 2 Diabetes

BolusCal2
Start date: September 2016
Phase: N/A
Study type: Interventional

The investigators hypothesize that non-optimal basal-bolus insulin treated patients with type 2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use of an automated bolus calculator. Additionally, the investigators propose that this intervention will lead to improvement in patient related outcomes.

NCT ID: NCT02883127 Completed - Type 2 Diabetes Clinical Trials

Motivational Interviewing With Focus on Diet and Weight Gain in Pregnant Women With Type 2 Diabetes

Start date: August 1, 2015
Phase:
Study type: Observational

The primary goal of this case control study is to investigate the effect of implementation of motivational interviewing with focus on diet and weight gain in addition to the routine treatment on prevention of excessive gestational weight gain and fetal growth in pregnant women with type 2 diabetes. Design: Prospective cohort study where an unselected cohort of all pregnant women with type 2 diabetes are offered intervention with motivational interviewing in addition to routine treatment in the period 2015-2017. For comparison a historical cohort (2013-2015) treated with routine treatment only will be studied. With an inclusion period of 2 years, each cohort is expected to include 150 participants. The women in the study group will receive one-to-one coaching based on the principles of motivational interviewing, every second week throughout the pregnancy. Both cohorts receive the same routine care for pregnant women with type 2 diabetes. An appropriate GWG is targeted. Primary outcome measures are maternal gestational weight gain and the infants Large for Gestational Age.

NCT ID: NCT02868177 Completed - Obesity Clinical Trials

Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes

TOTUM-63 TWO
Start date: October 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Given the data on the active ingredients of Totum-63, this research aims to evaluate the effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially on fasting plasma glucose in volunteers with abdominal obesity associated with impaired glucose tolerance or untreated type 2 diabetes and hypertriglyceridemia. This clinical study is designed to estimate the effect of Totum-63, active ingredient of Valedia, on several glucose and lipid homeostasis related parameters since these data are still unknown for this specific dietary supplement formula. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.