- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01839071
Influence of Vasculary Inflammation on Development of Diabetes
June 24, 2014 updated by: RWTH Aachen University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
109
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Rhine Westfalia
-
Aachen, North Rhine Westfalia, Germany, 52074
- University Hospital Aachen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: biopsy of fat tissue
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat tissue biopsy
Time Frame: 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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood collection
Time Frame: 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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
March 21, 2013
First Submitted That Met QC Criteria
April 19, 2013
First Posted (Estimate)
April 24, 2013
Study Record Updates
Last Update Posted (Estimate)
June 25, 2014
Last Update Submitted That Met QC Criteria
June 24, 2014
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-077
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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