Chromium and Insulin Action

Type 2 Diabetes Clinical Trial

Official title:

Effect of Chromium Picolinate on Metabolic and Physiologic Parameters in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283777
• Other study ID #: PBRC 23041
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2006
• Last updated: April 7, 2016
• Start date: August 1998
• Est. completion date: April 2003

Study information

• Verified date: April 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• 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 on blood glucose levels and insulin sensitivity

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 (4). 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, and over a 10 month period of observation, used established techniques to assess changes in insulin sensitivity, body composition and glycemic control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

Type 2 diabetes on diet therapy or low dose oral agent -

Exclusion Criteria:

Significant cardiovascular, hepatic or renal disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Chromium Picolinate

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

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 Senstivity, glycated hemoglobin
Secondary	weight, body composition