Type 2 Diabetes
Conditions
Keywords
insulin, glucose, chromium
Brief 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
Detailed 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.
Interventions
DIETARY_SUPPLEMENTchromium picolinate 1000 mcg daily vs placebo
chromium picolinate 1000 mcg daily vs placebo
OTHERPlacebo
Placebo
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps | at study enpoints |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed