Diabetes Mellitus Clinical Trial
Official title:
Changes of the Endothelial Glycocalyx, the Elastic Properties of the Arteries and the Coronary Flow Reserve (CFR) During Oral Glucose Tolerance Test in Patients With New Onset Diabetes Mellitus and First-degree Relatives
NCT number | NCT02244736 |
Other study ID # | K-DM-ATTIKON |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2013 |
Est. completion date | March 2015 |
Verified date | October 2018 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. The association between damage of endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and first degree relatives has not been explored. The purpose of this study is to explore the association between damage of endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and first-degree relatives before and after during oral glucose tolerance test (OGTT).
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - subjects without known diabetes - first degree relatives of diabetics Exclusion Criteria: - coronary or valvular heart disease - congestive heart failure - peripheral vascular disease - liver or kidney failure - history of alcohol or drug abuse |
Country | Name | City | State |
---|---|---|---|
Greece | ''Attikon'' University General Hospital | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences of vascular function at baseline and during OGTT among the 3 groups. | Differences of pulse wave velocity, augmentation index and central aortic blood pressure at baseline and during OGTT among the 3 groups. | Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT. | |
Primary | Differences of endothelial function at baseline and during OGTT among the 3 groups. | Differences of coronary flow reserve and endothelial glycocalyx thickness at baseline and during OGTT among the 3 groups. | Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT. | |
Secondary | Insulin resistance and arterial stiffness | Association of insulin resistance with changes of pulse wave velocity, augmentation index and central aortic blood pressure during OGTT | Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT. | |
Secondary | Insulin resistance and endothelial function | Association of insulin resistance with changes of coronary flow reserve and endothelial glycocalyx during OGTT | Baseline, 30 min, 60 min, 90 min,120 min of OGTT |
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