- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00997659
Chromium's Effect on Insulin Resistance in Obesity
August 11, 2011 updated by: Stony Brook University
Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- Stony Brook University GCRC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: chromium picolinate
|
1000 mg per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time 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)
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
October 16, 2009
First Submitted That Met QC Criteria
October 16, 2009
First Posted (Estimate)
October 19, 2009
Study Record Updates
Last Update Posted (Estimate)
August 12, 2011
Last Update Submitted That Met QC Criteria
August 11, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Hyperinsulinism
- Obesity
- Insulin Resistance
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Trace Elements
- Micronutrients
- Chelating Agents
- Sequestering Agents
- Iron Chelating Agents
- Chromium
- Picolinic acid
Other Study ID Numbers
- 2007-5689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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