Back to resultsInfluence of Vasculary Inflammation on Development of Diabetes
Primary Purpose
Coronary Artery Disease(CAD)
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease(CAD)
Eligibility Criteria
Inclusion Criteria:
- all patients with MI
- signed informed consent
- older than 18 years
- ability to give informed consent
Exclusion Criteria:
- absence of legal competence
Sites / Locations
- University Hospital Aachen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
biopsy of fat tissue
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01839071
Brief Title
Influence of Vasculary Inflammation on Development of Diabetes
Official Title
Influence of Vasculary Inflammation on Development of Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease(CAD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
biopsy of fat tissue
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
biopsy
Primary Outcome Measure Information:
Title
Fat tissue biopsy
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Blood collection
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients with MI
signed informed consent
older than 18 years
ability to give informed consent
Exclusion Criteria:
absence of legal competence
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
State/Province
North Rhine Westfalia
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
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Influence of Vasculary Inflammation on Development of Diabetes
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