Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Chromium and Insulin Action

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398853
• Other study ID #: 1R01DK060126
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2006
• Last updated: April 7, 2016
• Start date: October 2003
• Est. completion date: June 2009

Study information

• Verified date: April 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps

Description:

Detailed Description:

The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. However, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. Unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities.

One supplement that has attracted considerable clinical interest is chromium (Cr). However, routine use of Cr in subjects with diabetes is not currently recommended. In part, the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations. As such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation. In order to provide a comprehensive clinical evaluation of Cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with Type 2 diabetes. Individuals had baseline measures consisting of oral glucose tolerance testing, body fat and adiposity assessed, and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps. Individuals were evaluated for 6 months at which time repeat testing was done.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• On no meds to alter glucose metabolism

• age greater than 25 years old

• Fasting glucose greater than 125 mg/dl at screening

Exclusion Criteria:

• Subjects on insulin

• Sujbects on meds that alter glucose metabolism

• Use of glitazones

• C0-existing disorders in major organ systems such as heart, kidneys, liver

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• chromium picolinate 1000 mcg daily vs placebo
chromium picolinate 1000 mcg daily vs placebo

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps		at study enpoints	No
Secondary	glucose control		at study endpoints	No
Secondary	body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans		at study endpoints	No