Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Chromium and Insulin Action

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: chromium picolinate 1000 mcg daily vs placebo
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chromium Picolinate<br>Chromium | Dietary Supplement: chromium picolinate 1000 mcg daily vs placebo<br>* chromium picolinate 1000 mcg daily vs placebo<br>|
| Other: Placebo<br>Placebo | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps |  | at study enpoints | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose control |  | at study endpoints | 
| body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans |  | at study endpoints | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin, glucose, chromium