| Trial ID: | L6791 |
| Source ID: | NCT00289354
|
| Associated Drug: |
Chromium Picolinate (600 Mcg Cr) + Biotin (2 Mg)
|
| Title: |
Efficacy and Safety Study of Chromium Picolinate + Biotin on Glucose and Cholesterol Control in T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Chromium Picolinate (600 mcg Cr) + biotin (2 mg)
|
| Outcome Measures: |
Primary: 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) | Secondary: 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.
|
| Sponsor/Collaborators: |
Sponsor: Nutrition 21, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
600
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-03
|
| Completion Date: |
2005-11
|
| Results First Posted: |
|
| Last Update Posted: |
2006-02-09
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00289354
|
