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Prediabetic State clinical trials

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NCT ID: NCT02124590 Completed - Elderly Clinical Trials

The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function

Start date: June 2014
Phase: N/A
Study type: Interventional

This is a longitudinal study supported by Pfizer and is a collaboration between DMPI (Duke Molecular Physiology Institute) and DIAL (Duke Image Acquisition Laboratory) to measure the effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin sensitivity in the plasma. This pilot study seeks to explain why moderate intensity exercise provides more improvements in glucose control for pre-diabetic patients than vigorous intensity. The investigators hypothesize that moderate intensity exercise might be beneficial for elderly individuals who are overweight or obese, specifically by: 1. Reducing damaging excess protein acetylation (measured in muscle biopsy), 2. Improving the acylcarnitine/carnitine ratio (measured by MRS), 3. Improving overall mitochondrial function as reflected in reduced phosphocreatine recovery time (measured by MRS) and 4. Increasing insulin sensitivity as measured by a 4-hour oral glucose tolerance test. Investigators intend to use the results of this study to show feasibility in measuring mitochondrial function at Duke for a larger federal grant submission. Investigators hypothesize that carnitine insufficiency might contribute to mitochondrial dysfunction and obesity-related impairments in glucose tolerance and insulin action.

NCT ID: NCT02119325 Completed - Clinical trials for Impaired Fasting Glucose

The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

Start date: September 2013
Phase: N/A
Study type: Interventional

The primary aim of this study is to evaluate the effect of a fibre rich health food drink on the post prandial glucose and triglyceride peak in healthy overweight adults with impaired fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two period cross over study.

NCT ID: NCT02104739 Completed - Obesity Clinical Trials

Effects of Antidiabetic Medications on the Postprandial State in Prediabetes

Start date: April 2014
Phase: Phase 4
Study type: Interventional

This project addresses cardiovascular disease risk in patients with prediabetes. Levels of lipids after eating a meal ("postprandial lipids") are strong independent predictors of cardiovascular risk. Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid metabolism. These medications will be studied for their effect in reducing both postprandial lipid levels and arterial dysfunction.

NCT ID: NCT02084654 Completed - Insulin Resistance Clinical Trials

Exenatide and Weight Loss for Diabetes Prevention

Start date: November 2007
Phase: Phase 1
Study type: Interventional

Exenatide, a GLP-1 agonist approved for lowering blood glucose concentrations in patients with type 2 diabetes, has been associated with restoration of the first-phase insulin response when administered intravenously to patients with type 2 diabetes. In longer clinical trials, it is associated with progressive decreases in body weight, and improvement in the dyslipidemia that characterizes insulin resistance, although insulin resistance was not quantified. The investigators will seek to determine whether exenatide would have similar effects in individuals who were not diabetic. in particular, the drug effect on beta cell function and insulin sensitivity would be subject to less confounding by changes in blood glucose in the prediabetic population, allowing for clearer evaluation of the physiological effects of the drug on these metabolic endpoints. The investigators will compare 2 groups of prediabetic insulin resistant individuals, all on a weight loss diet and one group on exenatide and the other on placebo. The investigators will evaluate restoration of first phase insulin response, potential glucose lowering effects, including both reversal of prediabetes and hypoglycemia, and improvement in insulin resistance.

NCT ID: NCT02082756 Withdrawn - Prediabetes Clinical Trials

Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

Start date: November 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.

NCT ID: NCT02063048 Completed - Prediabetes Clinical Trials

Text Messaging for Weight Loss

Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effectiveness of text message-based support to usual care at promoting weight loss in patients with pre-diabetes.

NCT ID: NCT02060240 Completed - Obesity Clinical Trials

Physical Activity and Obesity

Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to see if a twelve-week exercise intervention in overweight or obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved skeletal muscle capillary blood flow by improving substances that dilate blood vessels and result in improved insulin sensitivity.

NCT ID: NCT02057497 Withdrawn - Prediabetes Clinical Trials

An Exploratory Clinical Trial to Generate Whole Blood Samples for Analysing Genetic Polymorphisms

Start date: October 9, 2017
Phase: N/A
Study type: Observational

G (guanine nucleotide binding) proteins associating with G protein-coupled receptors (GPCR) are key players in the pathogenesis of obesity and diabetes and are targets of pharmacotherapeutic inter-ventions. In addition, G proteins binding to GPCRs either directly or permissively determine the efficacy of lifestyle interventions and drugs aiming at weight management and diabetes treatment. Polymor-phisms of the fat mass and obesity-related protein (FTO) gene have been also well characterised and linked to energy intake, body fat mass as well as CVD risk and the susceptibility to weight-reducing interventions. Stratifying patients according to G protein and FTO-related genotyping may enable a more accurate prediction of individual disease courses and responses to therapeutic interventions in terms of safety and tolerability as well as efficacy. Although the objectives primarily refer to the analysis of G pro-tein and FTO-related genotypes, also other genes of potential relevance for the evolution of obesity and/ or diabetes and the response to lifestyle and pharmacological interventions may be analysed.

NCT ID: NCT02051842 Recruiting - NAFLD Clinical Trials

Effect of Metadoxine on Oxidative Stress in Non-alcoholic Hepatic Steatosis

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Oxidative stress is produced by imbalance between reactive oxygen species and antioxidant systems. This state is frequently associated with chronic diseases like obesity, insulin resistance, metabolic syndrome and hepatic steatosis. In the liver, the oxidative stress may trigger the progression of fatty liver disease, from triglyceride accumulation to inflammation, cirrhosis and hepatocellular carcinoma. Thus, the attenuation of oxidative stress, could be an important therapeutic target to lessen the severity of the disease. Until now, there is not a medical treatment to cure non-alcoholic fatty liver disease, but therapies aimed at reducing oxidative stress have been proposed. Metadoxine, an ionic complex of pyridoxine-pyrrolidone molecule, acts as a synthetic antioxidant, forming traps that can reduce free radicals; likewise, metadoxine has a proven capacity to reduce fat liver in alcoholic hepatitis. Finally, in fact that alcoholic and non-alcoholic liver diseases share molecular mechanisms in the generation of oxidative stress, the investigators propose metadoxine as a posssible modifier of the oxidative stress in non-alcoholic liver disease, prediabetic patients.

NCT ID: NCT02043405 Completed - Diabetes Clinical Trials

Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity

Start date: January 2014
Phase: N/A
Study type: Interventional

The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people.