NCT02006914

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

4.9 years

First QC Date

August 11, 2011

Last Update Submit

December 5, 2013

Conditions

Insulin Resistance

Keywords

Insulin resistanceHIV diseasechromium picolinate

Outcome Measures

Primary Outcomes (1)

  • Chromium Picolinate supplementation

    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.

    8 weeks

Study Arms (2)

Chromium Picolinate

Subjects who are HIV+ and insulin resistant

Dietary Supplement: Chromium Picolinate

Placebo

HIV+ and insulin resistant

Interventions

Chromium PicolinateDIETARY_SUPPLEMENT

Subjects will be asked to take chromium picolinate; 2 tablets per day, 1000 mcg or a placebo for a total of 8 weeks.

Also known as: Chromax
Chromium Picolinate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Anyone with a positive diagnosis of HIV disease.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Hospital GCRC

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

  • Stein SA, Mc Nurlan M, Phillips BT, Messina C, Mynarcik D, Gelato M. Chromium Therapy for Insulin Resistance Associated with HIV-Disease. J AIDS Clin Res. 2013 Sep 7;4(9):239. doi: 10.4172/2155-6113.1000239.

    PMID: 25346863RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Fat and muscle biopsy samples

MeSH Terms

Conditions

Insulin ResistanceAcquired Immunodeficiency Syndrome

Interventions

picolinic acid

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Marie C Gelato, MD, PhD

    Stony Brook University School of Medicine Dept. Of Medicine/Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Service Professor

Study Record Dates

First Submitted

August 11, 2011

First Posted

December 10, 2013

Study Start

June 1, 2005

Primary Completion

May 1, 2010

Study Completion

April 1, 2012

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

US(1)