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Chromium's Effect on Insulin Resistance in Obesity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00997659
Enrollment
40
Registered
2009-10-19
Start date
2007-04-30
Completion date
2010-05-31
Last updated
2011-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

Keywords

chromium picolinate, insulin resistance, obesity

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.

Interventions

DIETARY_SUPPLEMENTchromium picolinate

1000 mg per day

Sponsors

Stony Brook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026