Chromium's Effect on Insulin Resistance in Obesity
Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity
1 other identifier
interventional
40
1 country
1
Brief Summary
This research is to investigate the nutritional supplement chromium picolinate. A large number of people use chromium picolinate from health food stores to improve the function of the hormone insulin. The investigators are testing how effective this supplement is and are also monitoring its safety. In patients with diabetes, chromium has been shown to increase sensitivity to the hormone insulin. Since obesity can cause insensitivity or resistance to insulin, the investigators are studying obese individuals with documented insulin resistance. The investigators would like to know if chromium is also effective in treating the insulin resistance associated with obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2007
Typical duration 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
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 16, 2009
CompletedFirst Posted
Study publicly available on registry
October 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedAugust 12, 2011
August 1, 2011
2.7 years
October 16, 2009
August 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure used for sample size evaluations is the (before and after) change in the rate of glucose disposal during infusion of insulin (Rd, in mg of glucose/kg lean body mass/minute)
8 weeks
Study Arms (1)
chromium picolinate
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- age \> 18 years;
- a BMI greater or equal to 30; AND
- an abnormal 2 hour postprandial glucose (greater than 140 mg/dl but less than 200 mg/dl) following 75 grams of a glucose load.
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 g/dl or hemodynamically unstable;
- creatinine greater than or equal to 1.5 mg/dl;
- 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\>IOO mmHG);
- patients with diabetes mellitus;
- hypogonadism;
- abnormal thyroid function (serum T4 \< 4 or \> 12; TSH \< 0.35 or \> 5.5) (12) any chronic liver or kidney disease; OR
- polycystic ovarian syndrome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stony Brook University GCRC
Stony Brook, New York, 11794, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 16, 2009
First Posted
October 19, 2009
Study Start
April 1, 2007
Primary Completion
December 1, 2009
Study Completion
May 1, 2010
Last Updated
August 12, 2011
Record last verified: 2011-08