Phase 1
Completed N=21
A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01421355 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Change in Brachial Artery Diameter — -0.93 percentage of dilation
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brachial Artery Diameter |
-0.93 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01421355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.