Status:
COMPLETED
A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Specific Aim: To establish the feasibility of studying the change in endothelial function caused by induced moderate hyperbilirubinemia in type 1 diabetes. Atazanavir, a drug that inhibits bilirubin c...
Detailed Description
Diabetes mellitus (DM) is associated with a markedly increased risk of both macro- and microvascular disease. Excess pro-oxidants and insufficient antioxidants each contributes to oxidant stress in DM...
Eligibility Criteria
Inclusion
- Symptoms of diabetes plus casual plasma glucose concentration ≥ 200 mg/dl (11.1 mmol/l), or;
- FPG ≥ 126 mg/dl (7.0 mmol/l), or;
- 2-h postload glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT. In addition, subjects would be required to be at increased risk of cardiovascular events, defined as:
- microalbuminuria, or;
- T1DM duration of \> 20 years.
Exclusion
- HIV infection
- Gilbert's syndrome
- Hepatic failure or active hepatitis,
- Unstable cardiovascular disease, including angina, heart failure or arrhythmia
- drug abuse including alcoholism or addiction to cocaine, heroin or amphetamines
- Use of medications that significantly with atazanavir
- Pregnancy, or inability to practice adequate contraception
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01421355
Start Date
May 1 2012
End Date
February 1 2014
Last Update
July 21 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115