Chromium's Effect on Insulin Resistance in Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997659
• Other study ID #: 2007-5689
• Status: Completed
• Phase: N/A
• First received: October 16, 2009
• Last updated: August 11, 2011
• Start date: April 2007
• Est. completion date: May 2010

Study information

• Verified date: August 2011
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• chromium picolinate
1000 mg per day

Locations

Country	Name	City	State
United States	Stony Brook University GCRC	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes