- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00846248
Chromium and Insulin Resistance
August 30, 2012 updated by: University of California, San Francisco
Chromium is an essential nutrient for the maintenance of normal glucose tolerance and its deficiency causes insulin resistance.
Chromium administration has also been shown in several studies to lower glucose and insulin levels in patients with type 2 diabetes.
Accordingly, we propose to perform a placebo-controlled study of chromium picolinate administration in a cohort of non-obese, non-diabetic, insulin resistant subjects.
These subjects will be randomized to 16 weeks of therapy with either 500 mcg twice a day of Chromium or placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chromium is an essential nutrient for the maintenance of normal glucose tolerance and its deficiency causes insulin resistance.
Chromium administration has also been shown in several studies to lower glucose and insulin levels in patients with type 2 diabetes.
Moreover, studies in humans, animals and cell culture indicate that chromium enhances insulin signaling.
While these studies suggest that chromium administration increases insulin sensitivity, it has not been directly demonstrated that chromium has an effect in well defined insulin resistant subjects independent of hyperglycemia.
Accordingly, we propose to perform a placebo-controlled study of chromium picolinate administration in a cohort of non-obese, non-diabetic, insulin resistant subjects.
The insulin sensitivity of 80 subjects will be measured by a euglycemic insulin clamp.
Approximately 40 insulin resistant subjects will be randomized to 16 weeks of therapy with either 500 ug twice a day of chromium picolinate or placebo.
To quantitate the chromium-induced improvements, euglycemic hyperinsulinemic clamps to evaluate insulin sensitivity, OGTT using deuterated glucose to evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling pathways, will be performed before and after treatment.
We believe these studies will (1) confirm the beneficial effect of chromium on insulin sensitivity; (2) further our understanding of the molecular mechanisms of chromium action; and (3) because these insulin resistant subjects are at risk for the development of type 2 diabetes, the Metabolic Syndrome, and coronary artery disease (CAD), a demonstration of the beneficial effects of chromium on insulin action could ultimately have important public health consequences.
Study Type
Interventional
Enrollment (Actual)
75
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
-
-
California
-
San Francisco, California, United States, 94143
- UCSF
-
-
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 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Not exercising regularly, healthy, non-diabetic.
Exclusion Criteria:
- Diabetes, heart disease, hepatitis, HIV, impaired glucose tolerance, abnormal liver enzymes, abnormal TSH levels, other abnormal lab values.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Chromium picolinate
|
We will enroll non-obese, non-diabetic subjects with insulin resistance in a 16 week treatment program with 500 μg of chromium picolinate twice daily.
Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment.
Subjects will be compared to a placebo-treated group.
|
Placebo Comparator: 2
2 sugar pills taken twice daily
|
We will enroll non-obese, non-diabetic subjects with insulin resistance in a 16 week treatment program with 500 μg of chromium picolinate twice daily.
Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment.
Subjects will be compared to a placebo-treated group.
We will enroll non-obese, non-diabetic subjects with insulin resistance in a 16 week treatment program with 500 μg of chromium picolinate twice daily.
Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment.
Subjects will be compared to a placebo-treated group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
insulin resistance
Time Frame: 0 months and 4 months
|
0 months and 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Umesh Masharani, MD, University of California, San Francisco
- Principal Investigator: Martha Nolte, MD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2006
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
February 17, 2009
First Posted (Estimate)
February 18, 2009
Study Record Updates
Last Update Posted (Estimate)
August 31, 2012
Last Update Submitted That Met QC Criteria
August 30, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H847627262
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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