Chromium's Effect on Insulin Resistance in Obesity

Not Applicable

Completed

• Conditions: Obesity; Insulin Resistance
• Interventions: Dietary Supplement: chromium picolinate

• Registration Number: NCT00997659
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Primary Completion: 2009-12
• Study Completion: 2010-05
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-11
• Last Update Posted: 2011-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chromium picolinate	chromium picolinate	-

Primary Outcome Measures

Name	Time	Method
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)	8 weeks

Trial Locations

Locations (1)

Stony Brook University GCRC; 🇺🇸 Stony Brook, New York, United States