Efficacy and Safety Study of Chromium Picolinate + Biotin on Glucose and Cholesterol Control in T2DM
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.
Description
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Diabetes Mellitus, Type 2
Intervention
Chromium Picolinate (600 mcg Cr) + biotin (2 mg)
Status
Completed
Source
Nutrition 21, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00289354
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
Prediabetic State
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
Diabetes Mellitus, Type 1
A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.
Diabetes Mellitus, Lipoatrophic
A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).
Diabetic Ketoacidosis
A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.
Clinical Trials
The purpose of the proposed 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 glycem...
Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes
The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 d...
Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults
The purpose of this study is to determine the effectiveness of the nutritional supplement chromium picolinate in improving insulin resistance, a symptom of diabetes, in HIV-infected patien...
Effects of Chromium Picolinate on Food Intake
The purpose of this study is to test the effects of chromium picolinate on food intake, food cravings, eating attitudes, and appetite. If chromium picolinate is found to have a beneficial...
Chromium's Effect on Insulin Resistance in Obesity
This research is to investigate the nutritional supplement chromium picolinate. A large number of people use chromium picolinate from health food stores to improve the function of the hor...
PubMed Articles
The objective of the present study was to evaluate anti-diabetic effects of chromium picolinate (CrPic) and biotin supplementations in type 2 diabetic rats. The type 2 diabetic rat model was induced b...
Zinc, Copper, Iron, and Chromium Concentrations in Young Patients with Type 2 Diabetes Mellitus.
Homeostasis of trace elements can be disrupted by diabetes mellitus. On the other hand, disturbance in trace element status in diabetes mellitus may contribute to the insulin resistance and developmen...
ABSTRACT: BACKGROUND: The use of chromium supplements is widespread for the prevention and treatment of diabetes mellitus but there are conflicting reports on efficacy, possibly reflecting discrepant...
Chromium picolinate (CrPic) has shown both antidepressant and antidiabetic properties. In this study, the effects of CrPic on serotonergic properties and carbohydrate metabolism in diabetic rats were...
Chromium Effects on Glucose Tolerance and Insulin Sensitivity in People at Risk for Diabetes.
Objective: Chromium is widely marketed to the public with diverse health claims pertaining to glucose metabolism, insulin action, muscle mass, weight control, and diabetes prevention. This trial was d...
