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Completed

NCT Number: NCT00398853

Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes

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

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chromium picolinate 1000 mcg daily vs placebo

Dietary Supplement

chromium picolinate 1000 mcg daily vs placebo

Placebo

Other

Placebo

Primary outcomes

  1. Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps

    Time frame: at study enpoints

Secondary outcomes

  1. glucose control

    Time frame: at study endpoints

  2. body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans

    Time frame: at study endpoints

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Chromium and Insulin Action

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Nov 14, 2006
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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