A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus

Completed · Phase 1

Conditions studied: Type 1 Diabetes Mellitus

In brief

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 conjugation, will be used to induce moderate hyperbilirubinemia. Endothelial function will be measured before and after atazanavir therapy. In addition, plasma markers of antioxidant capacity and oxidant stress will be measured as proof-of-concept that induced moderate hyperbilirubinemia has favorable effects on oxidative stress in type 1 diabetes.

Key facts

Study ID

NCT01421355

Run by

Brigham and Women's Hospital

People needed

15

Starts

2012-05-01

Expected to finish

2014-02-01

Last updated by the study team

2014-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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