Chromium and Insulin Resistance
1 other identifier
interventional
75
1 country
1
Brief Summary
Chromium is an essential nutrient for the maintenance of normal glucose tolerance and its deficiency causes insulin resistance. Chromium administration has also been shown in several studies to lower glucose and insulin levels in patients with type 2 diabetes. Accordingly, we propose to perform a placebo-controlled study of chromium picolinate administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. These subjects will be randomized to 16 weeks of therapy with either 500 mcg twice a day of Chromium or placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 17, 2009
CompletedFirst Posted
Study publicly available on registry
February 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedAugust 31, 2012
August 1, 2012
3.5 years
February 17, 2009
August 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
insulin resistance
0 months and 4 months
Study Arms (2)
1
ACTIVE COMPARATORChromium picolinate
2
PLACEBO COMPARATOR2 sugar pills taken twice daily
Interventions
We will enroll non-obese, non-diabetic subjects with insulin resistance in a 16 week treatment program with 500 μg of chromium picolinate twice daily. Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment. Subjects will be compared to a placebo-treated group.
We will enroll non-obese, non-diabetic subjects with insulin resistance in a 16 week treatment program with 500 μg of chromium picolinate twice daily. Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment. Subjects will be compared to a placebo-treated group.
Eligibility Criteria
You may qualify if:
- Not exercising regularly, healthy, non-diabetic.
You may not qualify if:
- Diabetes, heart disease, hepatitis, HIV, impaired glucose tolerance, abnormal liver enzymes, abnormal TSH levels, other abnormal lab values.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF
San Francisco, California, 94143, United States
Related Publications (1)
Masharani U, Gjerde C, McCoy S, Maddux BA, Hessler D, Goldfine ID, Youngren JF. Chromium supplementation in non-obese non-diabetic subjects is associated with a decline in insulin sensitivity. BMC Endocr Disord. 2012 Nov 30;12:31. doi: 10.1186/1472-6823-12-31.
PMID: 23194380DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Umesh Masharani, MD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Martha Nolte, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- 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, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2011
Last Updated
August 31, 2012
Record last verified: 2012-08