Clinical trial NCT00398853: Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes
Official title: Chromium and Insulin Action
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: insulin
glucose
chromium
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps
timeFrame: at study enpoints
Secondary outcomes:
measure: glucose control
timeFrame: at study endpoints
measure: body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans
timeFrame: at study endpoints
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: William Cefalu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broskey NT, Obanda DN, Burton JH, Cefalu WT, Ravussin E. Skeletal muscle ceramides and daily fat oxidation in obesity and diabetes. Metabolism. 2018 May;82:118-123. doi: 10.1016/j.metabol.2017.12.012. Epub 2018 Jan 4.
citation: Cefalu WT, Rood J, Pinsonat P, Qin J, Sereda O, Levitan L, Anderson RA, Zhang XH, Martin JM, Martin CK, Wang ZQ, Newcomer B. Characterization of the metabolic and physiologic response to chromium supplementation in subjects with type 2 diabetes mellitus. Metabolism. 2010 May;59(5):755-62. doi: 10.1016/j.metabol.2009.09.023. Epub 2009 Dec 22.