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Chromium and Insulin Resistance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00846248
First received: February 17, 2009
Last updated: August 30, 2012
Last verified: August 2012

February 17, 2009
August 30, 2012
January 2006
July 2009   (final data collection date for primary outcome measure)
insulin resistance [ Time Frame: 0 months and 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00846248 on ClinicalTrials.gov Archive Site
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Chromium and Insulin Resistance
Chromium and Insulin Resistance

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Insulin Resistance
  • Dietary Supplement: Chromium
    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.
  • Dietary Supplement: placebo
    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.
  • Active Comparator: 1
    Chromium picolinate
    Intervention: Dietary Supplement: Chromium
  • Placebo Comparator: 2
    2 sugar pills taken twice daily
    Interventions:
    • Dietary Supplement: Chromium
    • Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
July 2011
July 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00846248
H847627262
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Umesh Masharani, MD University of California, San Francisco
Principal Investigator: Martha Nolte, MD University of California, San Francisco
University of California, San Francisco
August 2012

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