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Chromium's Effect on Insulin Resistance in Obesity

Primary Purpose

Insulin Resistance, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chromium picolinate
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring chromium picolinate, insulin resistance, obesity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Stony Brook University GCRC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chromium picolinate

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 16, 2009
Last Updated
August 11, 2011
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT00997659
Brief Title
Chromium's Effect on Insulin Resistance in Obesity
Official Title
Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity
Keywords
chromium picolinate, insulin resistance, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chromium picolinate
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
chromium picolinate
Intervention Description
1000 mg per day
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Stony Brook University GCRC
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

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