A 30 Day Acute Efficacy and Safety Study of Chromium Picolinate + Biotin on Glycemic Control in Overweight or Obese Subjects With T2DM
Diabetes Mellitus, Type 2
Drug: Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||”A Randomized, Double Blinded, Placebo Controlled, Parallel Arm, Study to Evaluate the Improvement in Glycemic Control After Daily Administration of Chromium Picolinate and Biotin in Patients With Type 2 Diabetes Mellitus”|
- Primary(baseline versus final): AUCg as recorded from a 2-hour OGTT with 75 g glucose beverage; fructosamine; fasting plasma glucose.
- Secondary (baseline versus final): Lipid panels (Total-C, HDL, LDL, VLDL), lipid ratios , apolipoprotein A and B.
|Study Start Date:||November 2003|
|Estimated Study Completion Date:||April 2004|
The purpose of this work is to assess the effects of a dietary supplement, containing chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on glycemic control in type 2 diabetes who are currently taking an oral antidiabetic agent (OAD) and failing therapy with OADs. Subjects entering the trial must have a HbA1c >/= 7.0% and have an OGTT >/= 200 mg/dL at 2 hours post consumption of a 75 g glucose beverage. The study is an acute 30 day intervention in conjunction with the subject's current OADs and standard of care in comparison to placebo.
Specifically, this study will assess whether use of the supplement will lower the post-prandial rise in blood glucose experienced after ingestion of a 75g carbohydrate load, relative to placebo, in type 2 diabetic patients as measured by the area under the curve for glucose (AUCg). The study will also assess the acute effects of supplementation over a 4-week period (relative to placebo) on fasting plasma levels of glucose, fructosamine, insulin, lipids and lipoproteins.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308451
|United States, Illinois|
|Radiant Research Chicago|
|Chicago, Illinois, United States, 60610|
|Principal Investigator:||Jeffery Geohas, MD||Radiant Research - Chicago|