NCT00845156

Brief Summary

Subjects will be screened with a 2 hour oral glucose tolerance test. After this screening visit, their insulin resistance will be measured. Subjects will then be given either alpha lipoic acid (antioxidant) or placebo for 6 weeks. The insulin resistance test will be repeated after the 6 weeks. We believe these studies will confirm the beneficial effect of alpha lipoic acid on insulin sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

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

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

2.7 years

First QC Date

February 17, 2009

Last Update Submit

June 18, 2013

Conditions

Insulin Resistance

Keywords

DiabetesInsulin resistancehealthy controlsanti oxidants

Outcome Measures

Primary Outcomes (1)

  • Insulin Resistance

    0 months and 4 months

Study Arms (2)

Anti-Oxidant

ACTIVE COMPARATOR

Alpha Lipoic Acid

Dietary Supplement: Alpha Lipoic Acid

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Alpha Lipoic Acid

Interventions

Alpha Lipoic AcidDIETARY_SUPPLEMENT

Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily

Anti-OxidantPlacebo

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, not exercising regularly

You may not qualify if:

  • Diabetes, Impaired glucose tolerance, Heart disease, Liver disease, HIV, abnormal TSH results, other abnormal lab values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Umesh Masharani, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Martha Kennedy, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

January 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

US(1)