Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease (PIOcard)
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Purpose
The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well as the degree of activation of the immune system, when given on top of an anti-diabetic treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic control.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus Cardiovascular Disease |
Drug: pioglitazone Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Effects of Pioglitazone in Patients With Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Vascular Complications : A Placebo-Controlled Study |
- Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation) [ Time Frame: 4 weeks ]
- Safety [ Time Frame: 4 weeks ]
- Metabolic control (HbA1c, Glucose) [ Time Frame: 4 weeks ]
| Enrollment: | 92 |
| Study Start Date: | June 2005 |
| Study Completion Date: | November 2006 |
PPARgamma activation by pioglitazone has shown to be associated with an improvement of cardiovascular risk when measured with clinical (assessement of intima-media-thickness) or biochemical (hsCRP, MMP-9 etc.) markers. Well controlled patients (HbA1c < 8.0 %) will receive either pioglitazone or placebo (randomised, double-blind) for 4 weeks. Blood will be drawn to investigate the change in cardiovascular or metabolic markers and mRNA will be isolated from circulating mononuclear cells to investiagte the degree of activation of the immune system, which is another measure for the risk of atherosclerosis development.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- type 2 diabetes mellitus
- stable oral treatment with metfromin and/or sulfonylurea
- age 20 - 80 years
- angiographically confirmed atherosclerosis or hsCRP > 1 mg/l
Exclusion Criteria:
- type 1 diabetes
- HbA1c > 8.5 %
- severe disease
- acute coronary syndrome
- contraindications to pioglitazone (heart failure etc.)
Contacts and Locations| Germany | |
| Dr. Michael Morcos | |
| Heidelberg, Germany | |
| IKFE | |
| Mainz, Germany, 55116 | |
| Principal Investigator: | Thomas Forst, MD | IKFE - Institute for Clinical Research and Development, Mainz |
| Study Director: | Andreas Pfützner, MD, PhD | IKFE - Institute for Clinical Research and Development, Mainz |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00479986 History of Changes |
| Other Study ID Numbers: | ATS-K-016 |
| Study First Received: | May 29, 2007 |
| Last Updated: | May 29, 2007 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by IKFE Institute for Clinical Research and Development:
|
diabetes mellitus monocyte activation cardiovascular risk |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Heart Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013