Chromium's Effect on Insulin Resistance in Obesity - Tabular View

Tracking Information

First Received Date ^ICMJE

October 16, 2009

Last Updated Date

October 16, 2009

Start Date ^ICMJE

April 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Chromium's Effect on Insulin Resistance in Obesity

Official Title ^ICMJE

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Insulin Resistance
Obesity

Intervention ^ICMJE

Dietary Supplement: chromium picolinate

1000 mg per day

Study Arms / Comparison Groups

chromium picolinate: Experimental

Intervention: Dietary Supplement: chromium picolinate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Dennis Mynarcik, PhD	(631) 444-3430	dmynarcik@notes.cc.sunysb.edu
Contact: Teresa Hunt-Goncalves, NP	(631) 444-9362

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00997659

Responsible Party

Dennis Mynarcik, PhD, Stony Brook University

Study ID Numbers ^ICMJE

2007-5689

Study Sponsor ^ICMJE

Stony Brook University

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Stony Brook University

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP