Efficacy and Safety Study of Chromium Picolinate + Biotin on Glucose and Cholesterol Control in T2DM
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
1 other identifier
interventional
600
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Mar 2003
Typical duration for not_applicable diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 7, 2006
CompletedFirst Posted
Study publicly available on registry
February 9, 2006
CompletedFebruary 9, 2006
February 1, 2006
February 7, 2006
February 7, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
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.
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of type 2 diabetes \> 12 months.
- Male and female between the ages of 18 and 70 years, inclusive.
- HbA1c \> 7.0%.
- Subject must be receiving an anti-hyperglycemic medication. Medication dosage must be stable for at least 60 days prior to entering trial. Insulin usage must be for rescue purposes only. Rescue insulin use may not be more than once per week.
- Subjects with a body mass index (BMI) \>/= 25 and \< 35.
- Subject must be ambulatory.
- Willing to perform self-administered blood glucose monitoring.
- Willing to complete all study related requirements.
- Subject will provide written consent to participate in the trial and this consent must be given voluntarily.
You may not qualify if:
- Diagnosis of type 1 diabetes.
- Hypoglycemic event requiring EMS intervention within 12 months.
- Diabetic Ketoacidosis (DKA) within 12 months.
- Subjects taking any supplement containing chromium picolinate within the last 90 days prior to enrollment.
- Subjects taking a supplement or multivitamin containing any other form of chromium \> 120 mcg/daily within the last 30 days prior to enrollment.
- Creatinine \> 2.0 x ULN; AST or ALT \> 2.0 x ULN; Total Bilirubin \> 1.5 x ULN
- COPD, CHF, Angina, HTN, MI, or any other CVD requiring hospitalization within 12 months.
- History of cerebrovascular accident (CVA), pulmonary embolism (PE), or an unresolved deep vein thrombosis (DVT).
- History of CABG, PTCA, or any other reperfusion therapy within 12 months.
- Seated systolic BP \> 160 mmHg.
- Morbid obesity.
- Any psychiatric or mental health issue that would prevent the subject from completing the study. (e.g. Severe depression, schizophrenia, high suicide risk, bi-polar disorder, dementia, substance abuse, etc,)
- History of any serious immunosuppressive disorder or current immunosuppressive therapy.
- Female subjects who are pregnant or nursing, or are planning on becoming pregnant during the study.
- Any illness or complication factor that, in the opinion of the investigator, would jeopardize the subject's health or well being by participating in the study or would interfere with the subject successfully completing the study.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Albarracin C, Fuqua B, Geohas J, Juturu V, Finch MR, Komorowski JR. Combination of chromium and biotin improves coronary risk factors in hypercholesterolemic type 2 diabetes mellitus: a placebo-controlled, double-blind randomized clinical trial. J Cardiometab Syndr. 2007 Spring;2(2):91-7. doi: 10.1111/j.1559-4564.2007.06366.x.
PMID: 17684468DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manley R Finch
Nutrition 21, Inc.
- PRINCIPAL INVESTIGATOR
Cesar Albarracin, MD
Alpha Therapy Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 7, 2006
First Posted
February 9, 2006
Study Start
March 1, 2003
Study Completion
November 1, 2005
Last Updated
February 9, 2006
Record last verified: 2006-02