Viewing Study NCT00147264



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Last Modification Date: 2024-10-26 @ 9:14 AM
Study NCT ID: NCT00147264
Status: COMPLETED
Last Update Posted: 2016-12-14
First Post: 2005-09-02

Brief Title: Telmisartan-Induced Reduction in Intra-Myocellular Lipids Trial
Sponsor: McMaster University
Organization: McMaster University

Study Overview

Official Title: A Randomized Double Blind 2X2 Factorial Design Study to Evaluate the Effects of Telmisartan vs Placebo and of a Low-Glycemic Diet vs Control Diet in Reducing Intra-Myocellular Lipids In Individuals With Abdominal Obesity
Status: COMPLETED
Status Verified Date: 2016-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine whether telmisartan andor a low-glycemic index diet are effective in reducing intra-myocellular lipid muscle fat content
Detailed Description: The metabolic syndrome currently affects over 20 of the adult population in Canada Patients with abdominal obesity are at markedly increased risk for diabetes and heart disease Recent studies have shown that decreased sensitivity to insulin insulin resistance a hallmark of the metabolic syndrome is related to increased storage of fat in muscle cells muscle fat Several recent studies indicate that blocking the renin-angiotensin system RAS may improve insulin sensitivity and prevent the development of type 2 diabetes Other data suggests that this effect may be due to the effect of RAS blockade on the recruitment and growth of adipose tissue The primary aim of this study is therefore to explore the role of angiotensin II in the development of insulin resistance Specifically we will examine the mechanisms underlying the putative anti-diabetic effect of RAS blockade by examining the effect of angiotensin receptor blockade on muscle fat content in individuals with the abdominal obesity This study will therefore test the hypothesis that treatment with the angiotensin receptor blocker telmisartan Micardis will reduce muscle fat thereby improving insulin sensitivity in people with abdominal obesity with or without additional features of the metabolic syndrome A number of dietary factors can also affect insulin sensitivity and may influence muscle fat Recent studies suggest that increasing the content of low-glycemic foods carbohydrates which are less easily digested can improve insulin sensitivity and lipid profile in patients with insulin resistance A second aim of this study is therefore to test the hypothesis that a low-glycemic diet will reduce muscle fat thereby improving insulin sensitivity in this population

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CIHR - 116099 None None None
BI Pharmaceuticals - 502433 None None None