Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults
NCT ID: NCT00109746
Last Updated: 2016-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2005-11-30
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Novel Therapy for Glucose Intolerance in HIV Disease
NCT02006914
To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities
NCT00152893
The Study of HIV Protease Inhibitors and Their Effects on Glucose Metabolism
NCT00259727
Effects of Uridine Supplementation on Metabolic Side Effects of Stavudine and Zidovudine
NCT00471614
Diet, Exercise and/or Rosiglitazone for HIV-Associated Insulin Resistance
NCT00264251
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will last 2 months. Participants will be randomly assigned to receive either chromium picolinate or placebo once a day for 2 months. Participants will have four overnight visits at the research center and two additional daytime visits for safety monitoring. During the overnight visits, participants will undergo a euglycemic hyperinsulinemic clamp, in which a continuous infusion of insulin is given through a vein and glucose levels are monitored through blood samples taken every 5 to 10 minutes. Fat tissue biopsies will also be conducted at the overnight study visits. During the safety monitoring visits, blood collection will occur for kidney and liver function tests, CD4 count, and viral load assessment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chromium Picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
chromium picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Placebo
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
chromium picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Currently taking an anti-HIV drug regimen
* Insulin Resistant:fasting glucose between 5.56 and 7mmol/L and/or two hour post-glucose load between 7.78 and 11.11mmol/L
Exclusion Criteria
* Acute illness that would interfere with the study
* Hypogonadism
* Hypothyroidism
* Untreated hypertension
* CD4 count less than 300 cells/mm3
* Viral load greater than 35,000 copies/ml
* Untreated hepatitis C virus infection
* Pregnancy
* Diabetes
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Office of Dietary Supplements (ODS)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marie Gelato
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marie C. Gelato, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State University of New York/General Clinical Research Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
State University of New York/General Clinical Research Center
Stony Brook, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
El-Sadr WM, Mullin CM, Carr A, Gibert C, Rappoport C, Visnegarwala F, Grunfeld C, Raghavan SS. Effects of HIV disease on lipid, glucose and insulin levels: results from a large antiretroviral-naive cohort. HIV Med. 2005 Mar;6(2):114-21. doi: 10.1111/j.1468-1293.2005.00273.x.
Howard AA, Floris-Moore M, Arnsten JH, Santoro N, Fleischer N, Lo Y, Schoenbaum EE. Disorders of glucose metabolism among HIV-infected women. Clin Infect Dis. 2005 May 15;40(10):1492-9. doi: 10.1086/429824. Epub 2005 Apr 11.
Taiwo BO. Insulin resistance, HIV infection, and anti-HIV therapies. AIDS Read. 2005 Apr;15(4):171-6, 179-80.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R21 AT002499-01A1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.