NCT00109746

Brief Summary

The purpose of this study is to determine the effectiveness of the nutritional supplement chromium picolinate in improving insulin resistance, a symptom of diabetes, in HIV-infected patients. The ultimate goal is to find a simple therapy that can prevent the development of diabetes in individuals with HIV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_1

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

First Submitted

Initial submission to the registry

May 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2005

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 23, 2016

Status Verified

May 1, 2013

Enrollment Period

3.5 years

First QC Date

May 2, 2005

Last Update Submit

March 22, 2016

Conditions

Insulin ResistanceHIV Infections

Keywords

HIVTreatment ExperiencedAnti-Retroviral AgentsAntiretroviral Therapy, Highly ActivePicolinic acidDietary Supplements

Outcome Measures

Primary Outcomes (1)

  • Improvement in insulin sensitivity

    8 weeks

Study Arms (2)

Chromium Picolinate

ACTIVE COMPARATOR

HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.

Dietary Supplement: chromium picolinate

Placebo

NO INTERVENTION

HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.

Interventions

chromium picolinateDIETARY_SUPPLEMENT

HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.

Chromium Picolinate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • 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

You may not qualify if:

  • Cancer
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York/General Clinical Research Center

Stony Brook, New York, 11794, United States

Location

Related Publications (3)

  • 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.

    PMID: 15807717BACKGROUND

  • 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.

    PMID: 15844072BACKGROUND

  • Taiwo BO. Insulin resistance, HIV infection, and anti-HIV therapies. AIDS Read. 2005 Apr;15(4):171-6, 179-80.

    PMID: 15844237BACKGROUND

MeSH Terms

Conditions

Insulin ResistanceHIV Infections

Interventions

picolinic acid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marie C. Gelato, MD, PhD

    State University of New York/General Clinical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2005

First Posted

May 3, 2005

Study Start

November 1, 2005

Primary Completion

May 1, 2009

Study Completion

June 1, 2010

Last Updated

March 23, 2016

Record last verified: 2013-05

Locations

US(1)