Chromium and Insulin Resistance

• ClinicalTrials.gov Identifier: NCT00846248
• Recruitment Status: Completed
• First Posted: February 18, 2009
• Last Update Posted: August 31, 2012
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Insulin Resistance	Dietary Supplement: Chromium; Dietary Supplement: placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Chromium and Insulin Resistance
• Study Start Date: January 2006
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: July 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Chromium picolinate	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.
Placebo Comparator: 2; 2 sugar pills taken twice daily	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.

Outcome Measures

Primary Outcome Measures :

1. insulin resistance [ Time Frame: 0 months and 4 months ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, California

UCSF

San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Umesh Masharani, MD; University of California, San Francisco
• Principal Investigator: Martha Nolte, MD; University of California, San Francisco

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Masharani U, Gjerde C, McCoy S, Maddux BA, Hessler D, Goldfine ID, Youngren JF. Chromium supplementation in non-obese non-diabetic subjects is associated with a decline in insulin sensitivity. BMC Endocr Disord. 2012 Nov 30;12:31. doi: 10.1186/1472-6823-12-31.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00846248
• Other Study ID Numbers: H847627262
• First Posted: February 18, 2009
• Last Update Posted: August 31, 2012
• Last Verified: August 2012

Keywords provided by University of California, San Francisco:

diabetes; insulin resistance; chromium; healthy volunteers

Additional relevant MeSH terms:

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Chromium; Trace Elements; Micronutrients; Physiological Effects of Drugs