A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus

NCT01421355 | Completed Phase 1 Results DMC

• 1 other identifier: 1R03DK094510-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Brachial Artery Diameter

  The primary endpoint is the difference in the change in brachial artery diameter in response to a flow stimulus at visit 2 and 3. It is anticipated that a response will occur following atazanavir therapy compared with baseline. The principal secondary endpoints are the serum measures of oxidant stress and antioxidant capacity.

  Day 0 and Day 4

Study Arms (1)

Atazanavir 300 mg BID

EXPERIMENTAL

Atazanavir 300 mg BID for 4 days.

Drug: Atazanavir

Interventions

Atazanavir DRUG

The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug.

Atazanavir 300 mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Atazanavir Sulfate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Joshua Beckman, MD
• Organization: Brigham and Women's Hospital

jbeckman@partners.org

617-732-6320

Study Officials

• Joshua Beckman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mark A. Creager, MD

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 22, 2011
• Study Start: May 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 21, 2014
• Results First Posted: July 21, 2014

Record last verified: 2014-06

Locations

US (1)