Novel Therapy for Glucose Intolerance in HIV Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marie Gelato, Stony Brook University
ClinicalTrials.gov Identifier:
NCT02006914
First received: August 11, 2011
Last updated: December 5, 2013
Last verified: December 2013

August 11, 2011
December 5, 2013
June 2005
May 2010   (final data collection date for primary outcome measure)
Chromium Picolinate supplementation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Hypothesis that chromium picolinate improved insulin-stimulated glucose uptake by increasing the insulin receptor-mediated tyrosine phosphorylation of insulin receptor substrate-1, resulting in increased association with phosphatidylinositol 3-kinase. There was a significant negative correlation between the fasting glucose levels and the insulin sensitivity.
Same as current
Complete list of historical versions of study NCT02006914 on ClinicalTrials.gov Archive Site
Not Provided
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Novel Therapy for Glucose Intolerance in HIV Disease
Novel Therapy for Glucose Intolerance in HIV Disease

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.

This study will test the hypothesis that chromium picolinate improves insulin-stimulated glucose uptake by increasing the insulin receptor-mediated tyrosine phosphorylation of insulin receptor substrate-1, resulting in increased association with phosphatidylinositol 3-kinase.

Specific Aim 1 will assess quantitative improvements in insulin-mediated glucose disposal in a placebo-controlled clinical trial of chromium supplementation with 1000mpg (19.2 pmol) of chromium as chromium picolinate, overa two-month course of therapy. The investigators have shown that the insulin resistance (i.e. the inability of insulin to stimulate glucose uptake into peripheral tissues like muscle) in patients with HIV disease is associated with a defect in the insulin-signaling pathway leading from the insulin receptor, through phosphatidylinositol 3-kinase(PI 3-K, Figure 5). A similar defect in intracellular signaling has also been reported in patients with type 2 diabetes mellitus ):15-171. The cellular mechanism of improved insulin sensitivity with chromium supplementation will be determined in Specific Aim 2.

Specific Aim 2 will assess the effect of chromium supplementation on the insulin-stimulated activity of insulin receptor substrate-I-associated phosphatidylinositol 3-kinase in biopsies of muscle and fat tissue. This aim will also test the hypothesis that these physiological effects of chromium are mediated by alterations in the activity of insulin signaling. Understanding this mechanism may facilitate the design of even more effective strategies for improving insulin sensitivity.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Fat and muscle biopsy samples

Probability Sample

Anyone with a positive diagnosis of HIV disease.

Insulin Resistance
Dietary Supplement: Chromium Picolinate
Subjects will be asked to take chromium picolinate; 2 tablets per day, 1000 mcg or a placebo for a total of 8 weeks.
Other Name: Chromax
  • Chromium Picolinate
    Subjects who are HIV+ and insulin resistant
    Intervention: Dietary Supplement: Chromium Picolinate
  • Placebo
    HIV+ and insulin resistant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
April 2012
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years and a diagnosis of HIV+ andlor AlDS made by standard CDC criteria.

Exclusion Criteria:

  1. positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
  2. diagnosis of cancer;
  3. acute illness of any sort, however, patients may be enrolled once they are stable;
  4. hemoglobin less than 11.0 gldl or hemodynamically unstable;
  5. creatinine greater than or equal to 1.5 mgldl;
  6. liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
  7. use of certain medications within the past month (e.g., glucocorticoids).
  8. untreated hypertension (systolic BP > 150 mmHG, diastolic BP>100 mmHG);
  9. patients with diabetes mellitus
  10. hypogonadism
  11. abnormal thyroid function (serum T'4 < 4 or > 12; TSH < 0.35 or > 5.5)
  12. 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).
  13. CD4 counts below 300
  14. 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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02006914
R21AT002499
Yes
Marie Gelato, Stony Brook University
Stony Brook University
Not Provided
Principal Investigator: Marie C Gelato, MD, PhD Stony Brook University School of Medicine Dept. Of Medicine/Endocrinology
Stony Brook University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP