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Insulin Resistance clinical trials

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NCT ID: NCT01041547 Completed - Insulin Sensitivity Clinical Trials

Vascular Function, Insulin Sensitivity, and Vitamin D

VIVID
Start date: December 2009
Phase: N/A
Study type: Observational

The overall objectives of this study are to examine the relationships between circulating vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin D deficiency in African Americans (AA) and White Hispanics (WH) is responsible for ethnic differences in insulin sensitivity and hypertension in AA, WH and European Americans (EA), as well as mechanisms underlying the association between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in AA and WH relative to EA is due to lower circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(OH)D. Acronyms: African American (AA), European American (EA), White Hispanics (WH), Serum 25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).

NCT ID: NCT01041365 Completed - Insulin Sensitivity Clinical Trials

Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents

DIVA
Start date: December 2009
Phase: N/A
Study type: Observational

The overall objectives of this study are to examine the relationships between circulating vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin D deficiency in AA is responsible for ethnic differences in insulin sensitivity and hypertension in AA and EA, as well as mechanisms underlying the association between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in AA relative to EA is due to lower circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(OH)D. Acronyms: African American (AA), European American (EA), Serum 25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).

NCT ID: NCT01040663 Completed - Obesity Clinical Trials

Isocaloric Dietary Interventions for Insulin Resistance and the Metabolic Syndrome

Start date: July 2009
Phase: N/A
Study type: Interventional

In recent decades, the prevalence of obesity has increased dramatically in the United States. Obesity has been associated with an increased risk of the metabolic syndrome, which is characterized by a cluster of metabolic derangements, including insulin resistance, high blood sugar, high triglycerides, low high density lipoprotein (HDL) cholesterol levels, high blood pressure, and inflammation. Lifestyle interventions, including dietary modification, physical activity, and weight loss, form the basis of treatment for individuals with the metabolic syndrome. However, the optimal composition of the diet is not known at this time. Furthermore, due to hormonal and metabolic changes that accompany weight loss, most people find it very difficult to maintain significant weight reductions over time. As a result, weight regain is exceedingly common.

NCT ID: NCT01038102 Completed - Obesity Clinical Trials

Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance

HEPFAT
Start date: February 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether substituting saturated fats with polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic variables in abdominally obese subjects

NCT ID: NCT01027325 Completed - Healthy Clinical Trials

Resistant Starch Insulin Sensitivity Trial

RESIST
Start date: June 2010
Phase: N/A
Study type: Interventional

The alarming increase in the prevalence of obesity is a cause of great concern given its association with many adverse health conditions, including insulin resistance and type 2 diabetes, which are associated with increased cardiovascular disease (CVD) risk. The primary objective of this project is to identify effective dietary strategies, focused on carbohydrate quantity and starch digestibility, to improve outcome variables associated with CVD risk in insulin resistant individuals who express components of the atherogenic lipoprotein phenotype (ALP). Current dietary guidelines emphasize substitution of carbohydrate calories for total and saturated fat calories for prevention and management of chronic disease. Yet, we and others have shown that high-carbohydrate diets increase the expression of the ALP, characterized by increased plasma triglycerides, reduced HDL cholesterol, and increased levels of small, dense LDL particles, and that this phenotype is reversed by moderate carbohydrate restriction. We have also shown that expression of stearoyl coenzymeA desaturase (SCD), an enzyme involved in triglyceride synthesis, is reduced with carbohydrate restriction and that this change is correlated with plasma triglyceride response. While carbohydrate restriction is effective for management of ALP, the role of starch quality has not been addressed. Furthermore, there has been no study of the effects of resistant vs. digestible starches incorporated into high- vs. lower carbohydrate diets. Since isolated reports suggest that increased intake of resistant starch lowers plasma triglycerides and postprandial insulinemia, we hypothesize that starch quality is an important determinant of components of ALP, and that this may be mediated in part by reduced adipose tissue SCD expression. Aim 1 and of this proposal will address this hypothesis by a controlled dietary intervention in 52 insulin resistant men and women in which changes in plasma lipids, lipoproteins and lipogenic gene expression will be determined after substituting resistant starch for digestible starch in a high- vs. lower-carbohydrate diet. In Aim 2, the fasting and postprandial glucose and insulin responses to a resistant vs. digestible starch meal will be measured to test the hypothesis that starch digestibility improves glycemic and insulinemic control in a way that relates to diet-induced changes in plasma lipids and lipoproteins.

NCT ID: NCT01023750 Completed - Insulin Resistance Clinical Trials

Predictors of Response to Fenofibrate

PreFar
Start date: January 2010
Phase: Phase 4
Study type: Observational

Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there are no screening tests to identify poor responders. Genetic and environmental factors may explain the high variability in response. Although exploratory in nature, this study is of clinical and public health importance because prediction of drug response among those with hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large ($90 to $130/patient/month); targeting the responsive patients at the outset will help improve treatment outcomes at a lower cost. If successful, the investigators will propose to conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate response.

NCT ID: NCT01021878 Completed - Clinical trials for Disorders Associated With Peritoneal Dialysis

Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients

STARCH
Start date: October 2009
Phase: Phase 4
Study type: Interventional

1. LOCATION OF STUDY: Multicentric study in Brazil. 2. PURPOSE OF THE STUDY: To measure changes in HOMA index when non-diabetic patients in APD were exposed to 7,5% Icodextrin for the long-dwell; and to compare such changes with those produced by 2,5% glucose for the long-dwell. 3. PRIMARY OUTCOME: The primary efficacy outcome was to measure HOMA index to set the differences with regard to baseline values of this variable for the two groups as well as in each group, which showed control of the glucose metabolism. STAGE OF THE STUDY : Phase IV postmarket study DESIGN: Randomized, open-label, multicenter study. Patients were randomized to receive either to Extraneal (7,5% Icodextrin) or 2.5% Dianeal during the long-dwell. SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 120 60 ExtranealTM 60 30 Dianeal® 60 30 Duration: 1 year.

NCT ID: NCT01019642 Completed - Diabetes Clinical Trials

Vitamin D, C-reactive Protein and Insulin Resistance

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

Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus. The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM). The trial was conducted from March to October 2008 at the Hospital of the Mexican Social Security in Cuernavaca, Mexico.

NCT ID: NCT01011062 Completed - Type 2 Diabetes Clinical Trials

Effect of Angiotensin Receptor Blockade on Insulin Resistance and Adipose Tissue Cytokines in Type 2 Diabetes

Start date: January 2004
Phase: N/A
Study type: Interventional

The study aims to investigate the effect of acute angiotensin receptor blockade on insulin action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose tissue in insulin-resistant subjects with type 2 diabetes and healthy controls. Hypothesis: Changes in adipocytokine concentrations and/or expressions and different reactions to acute in vivo induced hyperinsulinemia and angiotensin receptor blockade will be found in patients with type 2 diabetes compared to healthy subjects. A significant relationships between insulin sensitivity and selected adipokines and intracellular fat content and high energy phosphates in soleus muscle will be documented in healthy individuals, while no significant relation will be found in patients with type 2 diabetes.

NCT ID: NCT01007955 Completed - Insulin Resistance Clinical Trials

Assessment of Insulin Resistance, NAFLD, Predictors of CV Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass Surgery

Start date: November 2006
Phase: N/A
Study type: Observational

The purpose of this research is to further study the effect weight loss after gastric bypass surgery has on the heart and blood pressure and on how the body uses or metabolizes the sugars, fats and proteins we eat. Additionally, the researchers want to study fat tissue for gene patterns which may be responsible for where we carry fat on our bodies, as well as look carefully at a possible link between adipose tissue and insulin resistance. The researchers also want to evaluate the liver for the presence of fatty liver, which is common in people with obesity and is associated with insulin resistance, as well as study the liver for gene patterns which may be associated with non-alcoholic liver disease. Evaluating cardiovascular function and endocrine function before and after gastric bypass surgery, as well as studying adipose and liver tissue may help us understand the link between obesity, insulin resistance, fatty liver disease, high blood pressure and health problems such as diabetes and heart disease. Consequently, this may help in the future by identifying those who will benefit most from gastric bypass surgery.