Chromium's Effect on Insulin Resistance in Obesity

This study has been completed.

Sponsor:

Information provided by:

Stony Brook University

ClinicalTrials.gov Identifier:

NCT00997659

First received: October 16, 2009

Last updated: August 11, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 16, 2009
Last Updated Date	August 11, 2011
Start Date ^ICMJE	April 2007
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 16, 2009)	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) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00997659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Chromium's Effect on Insulin Resistance in Obesity
Official Title ^ICMJE	Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Insulin Resistance Obesity
Intervention ^ICMJE	Dietary Supplement: chromium picolinate 1000 mg per day
Study Arm (s)	Experimental: chromium picolinate Intervention: Dietary Supplement: chromium picolinate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	40
Completion Date	May 2010
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00997659
Other Study ID Numbers ^ICMJE	2007-5689
Has Data Monitoring Committee	Yes
Responsible Party	Dennis Mynarcik, PhD, Stony Brook University
Study Sponsor ^ICMJE	Stony Brook University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Stony Brook University
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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