Influence of the PPAR gamma -agonist Pioglitazone on endothelial function in the peripheral and myocardial vascular territories and on myocardial efficiency in obese subjects - Pioglitazone

Phase 1

• Conditions: There is an association between insulin resistance and endothelial dysfunction which is thought to be a critical factor in the development of vascular disease and thus an important factor in the development of atherosclerosis, hypertension and heart failure. Endothelial dysfunction can occur even in the vascular absence of angiographically defined disease and can be detected early in the spectrum of insulin resistance.

• Registration Number: EUCTR2004-003861-34-AT
• Lead Sponsor: Department of Nuclear Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-05
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Nondiabetic obese subjects between 20 to 50 years of age (BMI > 30 kg/m² in men or > 25 kg/m² in women; waist circumference >102 cm in men and > 88cm in women, n=44) with insulin resistance as suggested by an impaired fasting glucose concentration (>110 mg/dl), elevated triglyzerides (>130 mg/dl), a triglyzeride to HDL ratio > 3.0 and an insulin concentration above 109 pmol/l (> 15 µU/ml) will be included in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria will be coronary artery disease and any major medical illness including uncontrolled or malignant hypertension. Study participants should not take any medication known to influence insulin resistance or lipid metabolism and should be nonsmokers.
Controls will be healthy age matched subjects.
Also pregnant and nursing women are excluded from the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the proposed study is to evaluate the effect of Pioglitazone on endothelial function both in the macrocirculation and microcirculation as well as on myocardial oxygen consumption and myocardial efficiency in obese subjects with insulin resistance. ;Secondary Objective: ;Primary end point(s):