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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

October 16, 2009
August 11, 2011
April 2007
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00997659 on ClinicalTrials.gov Archive Site
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Chromium's Effect on Insulin Resistance in Obesity
Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Insulin Resistance
  • Obesity
Dietary Supplement: chromium picolinate
1000 mg per day
Experimental: chromium picolinate
Intervention: Dietary Supplement: chromium picolinate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. age > 18 years;
  2. a BMI greater or equal to 30; AND
  3. 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:

  1. positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
  2. diagnosis of cancer;
  3. acute illness of any sort, however, patients may be enrolled once they are stable;
  4. hemoglobin less than 11.0 g/dl or hemodynamically unstable;
  5. creatinine greater than or equal to 1.5 mg/dl;
  6. liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
  7. use of certain medications within the past month (e.g., glucocorticoids).
  8. untreated hypertension (systolic BP > 150 mmHG, diastolic BP>IOO mmHG);
  9. patients with diabetes mellitus;
  10. hypogonadism;
  11. abnormal thyroid function (serum T4 < 4 or > 12; TSH < 0.35 or > 5.5) (12) any chronic liver or kidney disease; OR
  12. polycystic ovarian syndrome.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00997659
2007-5689
Yes
Dennis Mynarcik, PhD, Stony Brook University
Stony Brook University
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Stony Brook University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP