Influence of Vasculary Inflammation on Development of Diabetes

Coronary Artery Disease(CAD) Clinical Trial

Official title:

Influence of Vasculary Inflammation on Development of Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839071
• Other study ID #: 10-077
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: June 24, 2014
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: November 2013
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Work, Health and Social Affairs in North Rhine-Westph
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease(CAD)
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• biopsy

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen	North Rhine Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat tissue biopsy	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.	2 years	No
Secondary	Blood collection	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.	2 years	No