Efficacy and Safety Study of Chromium Picolinate + Biotin on Glucose and Cholesterol Control in T2DM
|ClinicalTrials.gov Identifier: NCT00289354|
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : February 9, 2006
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Drug: Chromium Picolinate (600 mcg Cr) + biotin (2 mg)|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2003|
|Estimated Study Completion Date :||November 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289354
|Study Director:||Manley R Finch||Nutrition 21, Inc.|
|Principal Investigator:||Cesar Albarracin, MD||Alpha Therapy Center|