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Chromium's Effect on Insulin Resistance in Obesity

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ClinicalTrials.gov Identifier: NCT00997659
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : August 12, 2011
Information provided by:
Stony Brook University

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Dietary Supplement: chromium picolinate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity
Study Start Date : April 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: chromium picolinate Dietary Supplement: chromium picolinate
1000 mg per day

Primary Outcome Measures :
  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) [ Time Frame: 8 weeks ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997659

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United States, New York
Stony Brook University GCRC
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
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Responsible Party: Dennis Mynarcik, PhD, Stony Brook University
ClinicalTrials.gov Identifier: NCT00997659    
Other Study ID Numbers: 2007-5689
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011
Keywords provided by Stony Brook University:
chromium picolinate
insulin resistance
Additional relevant MeSH terms:
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Insulin Resistance
Nutrition Disorders
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Picolinic acid
Trace Elements
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action