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Prediabetic State clinical trials

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NCT ID: NCT02915198 Recruiting - Atherosclerosis Clinical Trials

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

VA-IMPACT
Start date: April 3, 2023
Phase: Phase 4
Study type: Interventional

This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in patients who have pre-diabetes and heart or blood vessel problems.

NCT ID: NCT02838693 Recruiting - Diabetes Clinical Trials

Assessing Progression to Type-2 Diabetes (APT-2D): A Prospective Cohort Study Expanded From BRITE-SPOT (Bio-bank and Registry for StratIfication and Targeted intErventions in the Spectrum Of Type 2 Diabetes)

APT-2D
Start date: March 2016
Phase: N/A
Study type: Observational

The Bio-bank and Registry for StratIfication and Targeted intErventions in the Spectrum Of Type 2 Diabetes (BRITE-SPOT) has been set up to prospectively collect clinical data and biologically relevant samples from individuals with, and at risk for type 2 diabetes (T2D), with the aim of delineating factors related to susceptibility, progression, complications and response to treatment. Expanded from BRITE-SPOT, Assessing the Progression to Type - 2 Diabetes (APT-2D) is a prospective cohort with a focus on non-diabetics (normoglycemic or prediabetic), to expand the sample size and depth of metabolic phenotyping in these upstream groups, with the more targeted aim of delineating factors related to insulin sensitivity versus secretion, that relate to progression to T2D.

NCT ID: NCT02683902 Recruiting - Obesity Clinical Trials

The Effect of Hypocaloric Diet Associated With tDCS on Weight Loss and Metabolic Profile

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

To compare four weeks of transcranial direct current stimulation (tDCS) versus placebo associated with a reduced caloric diet on weight loss, glycemic control and regulators of hunger and satiety in overweight or obese subjects with different degrees of glucose tolerance, submitted to hypocaloric diet.

NCT ID: NCT02681887 Recruiting - Obesity Clinical Trials

Effect of Melatonin on Cardiometabolic Risk- FULL

Start date: September 2016
Phase: Phase 3
Study type: Interventional

In a 12 week double-blind, placebo-controlled randomized trial, 120 subjects with obesity (BMI≥30 kg/m2) and pre-diabetes (HbA1c, 5.7-6.4%) will be randomly assigned 1:1 to receive either placebo or 2 mg of controlled-release melatonin, taken orally every evening 1 hour before bed. The investigators will assess melatonin's effect on insulin sensitivity by performing a hyperinsulinemic euglycemic glucose clamp and β-islet cell function measured using a hyperglycemic clamp, as a primary endpoint. The investigator will also evaluating melatonin supplementation's effect on mean 24-hour ambulatory blood pressure, nocturnal blood pressure, and potential intermediates including endothelial function using brachial ultrasound, catecholamine production using 24-hour epinephrine and norepinephrine excretion, and renin-angiotensin system activation using measurements of plasma renin activity, angiotensin II, and urine aldosterone excretion. The final endpoint will be to evaluate melatonin supplementation's effect on cellular cytokine and CC family chemokine expression as well as high sensitivity C-reactive protein, IL-6, and TNF-α. There will be a 24 week cohort phase as an extension of the trial. This will be an open-label prospective study of 50 subjects recruited from the trial who will take 2 mg of controlled-release melatonin nightly for 24 weeks after completion of the 12-week trial. At the end of the cohort-phase (36 weeks after entry in the trial), the investigators will again assess the extended use of melatonin supplementation on 24-hour BP, and glycemic control (HbA1, fasting glucose).

NCT ID: NCT02621008 Recruiting - Hypertension Clinical Trials

Mobile Phone-based Intervention for Promoting Healthy Habits and Weight Loss

Start date: November 2015
Phase: N/A
Study type: Interventional

A self administered 16 weeks plus follow up study to explore the efficacy of mobile phone driven apps for stress reduction coupled with guidance for healthy living among obese and overweight populations. The Study primary end points are weight of the participants, as well as glucose measurements (for subject with diabetes) and blood pressure (of subjects with hypertension).

NCT ID: NCT02609243 Recruiting - Obesity Clinical Trials

Diabetes Nutrition Algorithm - Prediabetes

DiNA-P
Start date: July 2013
Phase: N/A
Study type: Interventional

Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.

NCT ID: NCT02583061 Recruiting - Clinical trials for Type 2 Diabetes, Gestational Diabetes, Pre-diabetes

Toronto Gestational Glucose Tolerance Cohort

Start date: September 2003
Phase:
Study type: Observational

In this prospective observational cohort study, women representing the full spectrum of gestational glucose tolerance status are undergoing longitudinal cardiometabolic characterization at regular intervals in the years after the index pregnancy.

NCT ID: NCT02561377 Recruiting - Prediabetic State Clinical Trials

Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics)

Start date: September 2015
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of a 12-month resistance training on metabolic control and reducing the risk of diabetes.

NCT ID: NCT02559479 Recruiting - Obesity Clinical Trials

A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes

Start date: September 2015
Phase: N/A
Study type: Interventional

The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A dietary intervention is carried out during 6 months in 100 subjects who are individually randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35% protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates. Around 80% of total protein in diet comes from animal source (of whom around 40% from lean red meat). Subjects are provided with weekly menus and different recipes to use them as part of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the beginning of the study, after 3 and 6 months, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron, transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine samples are also collected to assess microalbuminuria and ureic nitrogen.

NCT ID: NCT02458586 Recruiting - Obesity Clinical Trials

Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)

UFOP-2
Start date: May 2015
Phase: N/A
Study type: Interventional

Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD). The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD. The study will compare two dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).