CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Fenofibrate 145mg PO QD +1 moredrug
Likely dose
Fenofibrate 145mg PO QDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00470262
NCT00470262N/ACompleted

Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation in Subjects With Impaired Glucose Tolerance

VA Office of Research and Development·interventional·Posted May 7, 2007·Updated Jul 21, 2016

In Brief

A clinical study evaluating Fenofibrate 145mg PO QD and Pioglitazone 45 mg PO QD for Metabolic Syndrome X and Prediabetic State. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The relationship between obesity and insulin resistance is known, however the mechanism(s) associating obesity with insulin resistance is not well understood. Inflammation and accumulation of fat in non fat tissue (like muscle) are conditions found on obesity which could be the potential link between obesity and insulin resistance. This study is designed to test the effects of two different drugs on numerous features of the obesity and insulin resistance in subjects with impaired glucose tolerance. Impaired glucose tolerance is a condition where blood sugar is too high after drinking a sugary drink containing 75 grams of sugar. Impaired glucose tolerant subjects are insulin resistant and at risk of developing diabetes. The drugs to be used are fenofibrate and pioglitazone. Fenofibrate is used to reduce the amount of fat (triglycerides) in the blood while pioglitazone is routinely used to make the body more sensitive to insulin in patients with diabetes. The purpose of this study is to compare the effects of either of these two medications (pioglitazone and fenofibrate) alone or the combination of both on fat accumulation in body (muscle) and inflammation. The amount of fat accumulation in muscle is thought to affect insulin sensitivity. In addition, the changes in the level of proteins produced by fat tissues will be studied in response to the two medications in this study. These proteins are thought to be involved in diabetes and insulin resistance. These studies are designed to examine fundamental clinical mechanisms underlying the metabolic syndrome and diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2007
Enrollment StartJan 1, 2007
Primary CompletionDec 1, 2012
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 19.2 years ago

Interventions

Fenofibrate 145mg PO QDdrug

Subjects will be randomized to either fenofibrates or combination of both fenofibrate and pioglitazone

Pioglitazone 45 mg PO QDdrug

Subjects will be randomized to either fenofibrate 145 mg PO QD or a combination of both fenofibrate 145 mg PO QD and pioglitazone 45 mg PO QD