Novel Therapy for Glucose Intolerance in HIV Disease
Completed · Has a placebo group
Conditions studied: Insulin Resistance
In brief
This research is to investigate the nutritional supplement chromium picolinate. The investigators are testing to see how effective this supplement is in treating insulin resistance associated with HIV disease.
Key facts
- Study ID
- NCT02006914
- Run by
- Stony Brook University
- People needed
- 47
- Starts
- 2005-06-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2013-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years and a diagnosis of HIV+ andlor AlDS made by standard CDC criteria.
You may not qualify if…
- positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
- diagnosis of cancer;
- acute illness of any sort, however, patients may be enrolled once they are stable;
- hemoglobin less than 11.0 gldl or hemodynamically unstable;
- creatinine greater than or equal to 1.5 mgldl;
- liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
- use of certain medications within the past month (e.g., glucocorticoids).
- untreated hypertension (systolic BP > 150 mmHG, diastolic BP>100 mmHG);
- patients with diabetes mellitus
- hypogonadism
- abnormal thyroid function (serum T'4 < 4 or > 12; TSH < 0.35 or > 5.5)
- hepatitis C infection (if patients have had prior therapy and are now stable with no evidence of active infection they will be included. This will depend upon documentation from primary care giver).
- CD4 counts below 300
- viral load greater than 35,000.
- Exclusion criteria (13) and (14) are added because the protocol requires that subjects be on a stable anti-retroviral regime for 3 months prior to study and 2 months on study. These criteria will make it less likely that anti-retroviral therapies will be switched in this subject population who are doing well.
Where it is running
- Stony Brook University Hospital GCRC — Stony Brook, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.