N/A
N=27
Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation
Metabolic Syndrome X · Prediabetic State
Bottom Line
View on ClinicalTrials.gov: NCT00470262 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Insulin Sensitivity — 1.48; 1.73; 1.89; 2.93 mg*kg^-1*min^-1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fenofibrate 145mg PO QD (Drug); Pioglitazone 45 mg PO QD (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity |
1.48; 1.73; 1.89; 2.93 | — |
| SECONDARY IMCL |
3.67; 5.32; 3.46; 2.82 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Impaired glucose tolerance and/or impaired fasting glucose and/or metabolic syndrome
- Age 18-65
- BMI 28-38
Exclusion Criteria
- Renal insufficiency: creatinine.1.4
- Liver disease: ALT.2x normal, congestive heart failure, history of documented coronary artery disease, concomitant use HMG CoA-reductase inhibitors (statins)
- Concurrent use of ASA, steroids and other anti-inflammatory agents
Data sourced from ClinicalTrials.gov (NCT00470262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.