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Impaired Glucose Tolerance clinical trials

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NCT ID: NCT00917449 Completed - Metabolic Syndrome Clinical Trials

Prevention of Type 2 Diabetes Mellitus by L-Arginine in Patients With Metabolic Syndrome

L-arginine
Start date: December 2005
Phase: Phase 3
Study type: Interventional

Aim The principal objective of this project is: • To evaluate the efficacy of long term (18 months) L-Arginine therapy in preventing or delaying clinical onset of type 2 diabetes mellitus in subjects with impaired glucose tolerance (IGT) and Metabolic Syndrome. Secondary end points are: 1. To define if a long term treatment with L-arginine is able to ameliorate insulin sensitivity and endothelial dysfunction in this population. 2. To find new risk profiles and candidate genes able to define the sub-group of patients at higher risk to develop type 2 diabetes mellitus. Methodology This is a double blind, parallel, one centre study to determine if long term oral L-arginine administration is able to delay or prevent type 2 diabetes mellitus in patients with Metabolic Syndrome. Two hundred and ninety four subjects were recruited at the Cardio-Metabolic and Clinical Trials Unit of the San Raffaele Scientific Institute. One hundred and forty two patients were randomized to enter the study and assigned to two arms: oral L-arginine (6.4 g/die) or placebo, in addition to diet and physical exercise. The treatment were maintained for 18 months. Visits were performed every 3 months for clinical evaluation, blood samples, treatment supply and collection of data on adverse events. Furthermore, patients were contacted every month by telephone to evaluate the accurate continuation of the study and they were instructed to phone to the centre in case of possible adverse events. An OGTT were performed before the enter into the study and at the end of the study period. An additional OGTT were performed at an intermediate visit if fasting glucose levels were more than 126 mg/dl. A diabetic response caused the end-point of the patient. Metabolic, hormonal and endothelial activation and inflammation parameters were measured. Evaluation of endothelium-mediated and non-endothelium-mediated vasodilatation were performed by strain gauche plethysmography evaluating forearm blood at the basal state. in post-ischemic conditions and after nitroglycerine administration. Before the enter into the study, an additional blood sample were drawn for DNA extraction and candidate genes variants evaluation. Before the enter into the study and at the end of the study period, gene expression for inflammation were measured on mRNA extraction on endothelial progenitor cells.

NCT ID: NCT00847899 Completed - Hypertension Clinical Trials

Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

Start date: January 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.

NCT ID: NCT00845182 Completed - Healthy Clinical Trials

Effect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function

PIO-EX
Start date: June 2007
Phase: Phase 4
Study type: Interventional

Pioglitazone, a drug used in treatment of type 2 diabetes has been shown to improve insulin sensitivity in skeletal muscle, liver, and fat cells. Despite the beneficial effects of pioglitazone to improve insulin sensitivity and reduce cardiovascular disease in high risk type 2 diabetic patients, weight gain has been a limiting factor. Exenatide, another agent used for treatment of T2DM, improves glycemic control and promotes moderate weight loss. In this proposal we will examine the effect of combination therapy with pioglitazone plus exenatide on body weight, fat topography, beta cell function, glycemic control, and plasma lipid levels in subjects with type 2 diabetes mellitus compared to treatment with each drug separately. Assessment of beta cell function will be performed by measuring the maximal insulin secretory capacity using a maximal hyperglycemic stimulus combined with an intravenous arginine stimulus.

NCT ID: NCT00841867 Completed - Clinical trials for Impaired Glucose Tolerance

The Role of Pulsatile Insulin Secretion (A Study Investigating the Effects of Partial Pacreatectomy on Glucose Metabolism)

Pilot OGTT
Start date: December 2008
Phase: N/A
Study type: Observational

The purpose of this study is to examine changes in sugar metabolism that may occur in subjects who have previously had part of their pancreas removed due to a benign lesion.

NCT ID: NCT00829660 Completed - Clinical trials for Acute Coronary Syndrome

Acarbose Cardiovascular Evaluation Trial

ACE
Start date: February 17, 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether acarbose therapy can reduce cardiovascular-related morbidity and mortality in patients with impaired glucose tolerance (IGT) who have established coronary heart disease (CHD) or acute coronary syndrome (ACS). A secondary objective of the study is to determine if acarbose therapy can prevent or delay transition to type 2 diabetes mellitus (T2DM) in this patient population.

NCT ID: NCT00722631 Completed - Clinical trials for Type 2 Diabetes Mellitus

Anti-Inflammatory Effects of Pioglitazone

Start date: May 2007
Phase: N/A
Study type: Interventional

There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. FDG-PET can visualize activated metabolic activity of inflammatory cells. It is possible that FDG-PET can detect atherosclerotic plaque inflammation and that FDG-PET can monitor the effect of pioglitazone on plaque inflammation.

NCT ID: NCT00685594 Completed - Clinical trials for Impaired Glucose Tolerance

Vitamin D for the Prevention of Diabetes Type 2

Start date: March 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.

NCT ID: NCT00675740 Completed - Clinical trials for Impaired Glucose Tolerance

Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

Start date: January 2004
Phase: Phase 4
Study type: Interventional

The aim of this study is to prospectively assess the relative benefits of either treatment with rosiglitazone or physical exercise on endothelial function in patients with impaired fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).

NCT ID: NCT00663000 Completed - Diabetes Clinical Trials

Glucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance

Start date: April 2008
Phase: N/A
Study type: Observational

Observational, Cross-sectional, longitudinal, multi-center, diagnostic study Cross-sectional part of the study: To evaluate the influence of acromegaly on glucose tolerance Longitudinal part of the study: To evaluate the changes of impaired glucose tolerance during standard treatment of acromegaly. Adult patients with established acromegaly Cross-sectional part of the study: 150 patients Longitudinal part of the study: 58 patients

NCT ID: NCT00652379 Completed - Insulin Resistance Clinical Trials

Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

Start date: June 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if co-treatment of acromegalic patients, who beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can be obtained at a neutral cost as compared to SA mono therapy. Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and intramyocellular fat.