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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003861-34-AT

Enrollment

Registered

2005-04-05

Start date

2005-06-08

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Actos 30 mg Product Name: Actos Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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):	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026