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Completed

NCT Number: NCT00997659

Chromium's Effect on Insulin Resistance in 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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Key information

Conditions

Insulin Resistance Body Weight Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University GCRC

Stony Brook, New York, 11794, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chromium picolinate

Dietary Supplement

1000 mg per day

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)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Oct 19, 2009
Registry last updated
Aug 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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