Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance
2 other identifiers
interventional
27
1 country
1
Brief Summary
Rates of cardiovascular disease and diabetes are more than 2-fold greater in HIV infected people than the general population. Protease inhibitor booster antiretroviral therapy (PI-ART) which is used by \~50% of HIV infected people in the USA is an established risk factor for diabetes. Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile salt, improves insulin sensitivity in HIV uninfected subjects, although the mechanisms for these benefits are unclear. This study will explore the hypothesis that TUDCA will improve insulin action in people with HIV who are receiving PI-ART. Further, this project will clarify the molecular mechanisms responsible for these improvements potentially benefiting society, irrespective of HIV status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 13, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedResults Posted
Study results publicly available
January 27, 2020
CompletedJanuary 27, 2020
January 1, 2020
4.7 years
June 11, 2013
May 31, 2019
January 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose Uptake
We will examine the ability of insulin to cause muscle to take up insulin. Each subject will receive intravenous insulin for 6 hours to see how much sugar needs to be given intravenously to keep the blood sugar normal, a measure called glucose uptake. We will compare glucose uptake measured as the amount of 20% dextrose that is needed to keep the blood sugar at \~100mg/dl during insulin infusion before and after 30 days of treatment with drug or placebo.
Glucose uptake is measured at baseline and 30 days after study intervention
Secondary Outcomes (3)
Body Composition
Pre-Treatment and Post 30 day-Treatment
Liver Fat
Pre-Treatment and Post 30 day-Treatment
Liver Function Tests
Pre-Treatment and Post 30 day-Treatment
Study Arms (2)
tauroursodeoxycholic acid
ACTIVE COMPARATORThis group will receive 1.75 grams per day of tauroursodeoxycholic acid given once daily for 30 days.
placebo
PLACEBO COMPARATORThis group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Interventions
The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.
The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Eligibility Criteria
You may qualify if:
- HIV+
- receiving protease inhibitor containing antiretroviral therapy for \>6 months
- Undetectable viral load
- insulin resistant
- impaired fasting glucose (fasting blood glucose\>100mg/dl)
- impaired glucose tolerance (blood glucose \>140mg/dl at 2 hours during oral glucose tolerance testing).
- abstained from medications that affect glucose (e.g. prednisone, growth hormone)
- stable medications for \>3 months
You may not qualify if:
- weight loss of \>5% of body weight in prior 6 months
- active gastrointestinal disease (gallstones, pancreatitis, hepatitis, diarrhea)
- use of anti-diabetic medications
- cardiovascular disease (uncontrolled hypertension, heart attack, heart failure, prior endocarditis)
- history of or active substance abuse
- blood clotting disorder or taking medications that affect blood clotting (e.g. coumadin, warfarin)
- pregnant, planning to become pregnant or lactating
- unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Kars M, Yang L, Gregor MF, Mohammed BS, Pietka TA, Finck BN, Patterson BW, Horton JD, Mittendorfer B, Hotamisligil GS, Klein S. Tauroursodeoxycholic Acid may improve liver and muscle but not adipose tissue insulin sensitivity in obese men and women. Diabetes. 2010 Aug;59(8):1899-905. doi: 10.2337/db10-0308. Epub 2010 Jun 3.
PMID: 20522594BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We were unable to recruit our targeted enrollment reducing the power of the study
Results Point of Contact
- Title
- Dr. Dominic Reeds
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Dominic N. Reeds, M.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2013
First Posted
June 13, 2013
Study Start
September 1, 2013
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
January 27, 2020
Results First Posted
January 27, 2020
Record last verified: 2020-01