Influence of Vasculary Inflammation on Development of Diabetes

Not Applicable

Completed

• Conditions: Coronary Artery Disease(CAD)
• Interventions: Procedure: biopsy

• Registration Number: NCT01839071
• Lead Sponsor: RWTH Aachen University

Brief Summary

The purpose of this study is to investigate if patients with coronary heart disease have higher risk to develop diabetes mellitus among the following two years.

The examination of biomarkers taken from blood and fat issue shall provide which factors could be responsible for development of diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-24
• Status Verified: 2013-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• all patients with MI
• signed informed consent
• older than 18 years
• ability to give informed consent

Exclusion Criteria

• absence of legal competence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
biopsy of fat tissue	biopsy	-

Primary Outcome Measures

Name	Time	Method
Fat tissue biopsy	2 years	Patients with Coronary artery disease(CAD) undergo a subcutane fat tissue biopsy to identify inflammation and diabetes biomarker, such as TNF, Adiponectin and Clock-Gene. This is done baseline, after 1 year and after 2 years. Comparison of the current measurements among the measurements of the following 2 years shall give evidence about the reasons and conditions of diabetes development.

Secondary Outcome Measures

Name	Time	Method
Blood collection	2 years	Blood of patients with Coronary artery disease(CAD)is taken to identify biomarkers of inflammation and diabetes, such as CRP, HbA1c, Adiponectin, Plasma MMp-9, s-ICAM-1, s-VCAM-1, P-selectin and Clock-Gene, CD11b/CD18, CD14, L-selectin, CD-64 and TNF. This is done baseline, after 1 year and after 2 years. Comparison of the current measurements among the measurements of the following 2 years shall give an evidence about the reasons and conditions of diabetes development.

Trial Locations

Locations (1)

University Hospital Aachen; 🇩🇪 Aachen, North Rhine Westfalia, Germany