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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
History of Changes
  Purpose

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 Intervention
Insulin Resistance
Obesity
 Dietary Supplement: chromium picolinate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: April 2007
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chromium picolinate Dietary Supplement: chromium picolinate
1000 mg per day

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997659

Locations
United States, New York
Stony Brook University GCRC
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
  More Information

No publications provided

Responsible Party: Dennis Mynarcik, PhD, Stony Brook University
ClinicalTrials.gov Identifier: NCT00997659     History of Changes
Other Study ID Numbers: 2007-5689
Study First Received: October 16, 2009
Last Updated: August 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
chromium picolinate
insulin resistance
obesity

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Chromium
 Insulin
Picolinic acid
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013