Efficacy and Safety Study of Chromium Picolinate + Biotin on Glucose and Cholesterol Control in T2DM
To evaluate the effect of the combination of chromium picolinate (600 μg Cr) + biotin (2 mg) versus placebo on glycosylated hemoglobin (HbA1c), lipid profiles (Total-C, HDL-C, LDL-C, TGs, TG/HDL ratio, etc), and pharmacoeconomic outcomes as measured at the Baseline Visit and 90 days later at the Final Visit. Secondarily, to measure the effect of chromium picolinate (600 μg Cr) + biotin (2 mg) versus placebo on patient quality of life, fasting and post-prandial blood sugar levels, fasting insulin, and anti-hyperglycemic medication usage.
Diabetes Mellitus, Type 2
Drug: Chromium Picolinate (600 mcg Cr) + biotin (2 mg)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Randomized, Double Blinded, Placebo Controlled, Study to Evaluate Improvements in Glycemic Control, Lipid Levels, Quality of Life and Healthcare Costs After Daily Administration of Chromium Picolinate and Biotin in Patients With T2DM|
- HbA1c: Baseline and Final Visits
- Lipid Panels (Total-C, HDL, LDL, LDL, VLDL, lipid ratios, etc)Baseline and Final Visits
- Pharmacoeconomic outcomes (as deduced by changes in HbA1c)
- Fasting Plasma Glucose: Baseline and Final Visits
- Fasting Insulin: Baseline and Final Visits
- HOMA-IR and HOMA-BCF: Baseline and Final Visits
- Quality of Life: Baseline and Final Visits
- Post Prandial Glucose: Diary recordings of post meal values, 90 day continuous.
- Change in Rx Antihyperglycemic agents: Assessed at baseline and compared to final visit.
- HAMD-29: Change in depression/mood status; measured at baseline and final at a subset of two research centers. (n~30).
- ANCOVAs: Treatment outcomes based on treatment group compared to gender, ethnicity, age, co-morbidities, Rx medications, glycemic states at entrance, lipid status at entrance.
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||November 2005|
There will be an Initial Pre-Screening Contact, two office visits (Baseline and Final), and two mid-study phone contacts with the subject during the course of the study. Volunteers will take either chromium picolinate (600 μg Cr) + biotin (2 mg) (n=400) or placebo (n=200) once daily just prior to the morning meal for 90 days. Assessments for glycosylated hemoglobin, lipid profiles, and quality of life will be taken at the Baseline Visit. After 90 days another set of assessments will be taken at the Final Visit for comparison with the baseline values. All subjects will under go a brief physical exam, a medical history assessment, and a comprehensive concomitant medications assessment as well as provide blood and urine samples at the baseline and final visits to ensure subject safety is maintained. The subject will be contacted, by a central call center, between visits at Day 30 and Day 60 to ensure study compliance by reminding the subject to take all doses of study product, perform the daily blood glucose monitoring, and complete the study diary daily.