Status:
COMPLETED
Skin and Retina Microvascular Endothelial Function in Healthy, Insulin Resistant and Type 2 Diabetic Subjects
Lead Sponsor:
ELAB-Logistics
Collaborating Sponsors:
Institute for Clinical Research and Development (ikfe) GmbH
Johannes Gutenberg University Mainz
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-70 years
Brief Summary
The purpose of this study is to investigate microvascular endothelial function in the retina of lean, obese, and type 2 diabetic subjects and to compare microvascular endothelial function in the retin...
Detailed Description
Insulin resistance is an early feature in obese patients lasting from hyperinsulinaemia with normal glycaemic control to impaired glucose tolerance and clinically manifest type 2 diabetes. Insulin res...
Eligibility Criteria
Inclusion
- Age: 30 to 70 years
- Have given informed consent to participate in this study in accordance with local regulations
- Are reliable and willing to make themselves available for the duration of the study and will abide by the study restrictions
Exclusion
- Smoking within the last 6 months
- Pre-proliferative or proliferative diabetic retinopathy
- Have a history of drug or alcohol abuse within the last 5 years
- Pregnant or intend to become pregnant during the course of the study
- Have a condition (including known drug abuse, alcohol abuse, or psychiatric disorder) which, in the opinion of the investigator, precludes the patient from following and completing the protocol
- Epilepsy
- Lack of compliance or another, similar reason, that, in the judge of the investigator, precludes satisfactory participation in the study.
- Treatment with nitrates, angiotensin converting enzyme (ACE)-inhibitors, or angiotensin (AT) II blockers
- Treatment with glitazones
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01241370
Start Date
May 1 2009
End Date
April 1 2010
Last Update
November 16 2010
Active Locations (1)
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1
ikfe GmbH, clinic
Mainz, Germany, 55116