A 30 Day Acute Efficacy and Safety Study of Chromium Picolinate + Biotin on Glycemic Control in Overweight or Obese Subjects With T2DM

NCT00308451 | Completed

• 1 other identifier: N21 CPB-03001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 glycemic control in type 2 diabetes. Specifically, this study will assess whether use of the supplement will lower the post-prandial rise in blood glucose experienced after ingestion of a 75g carbohydrate load, relative to placebo, in type 2 diabetic patients. The study will also assess the chronic effects of supplementation over a 4-week period (relative to placebo) on fasting plasma levels of glucose, insulin, lipids and lipoproteins.

Conditions

Diabetes Mellitus, Type 2

Keywords

chromium; chromium picolinate; type 2 diabetes mellitus; fructosamine; glycemic control; OGTT

Outcome Measures

Primary Outcomes (1)

• Primary(baseline versus final): AUCg as recorded from a 2-hour OGTT with 75 g glucose beverage; fructosamine; fasting plasma glucose.

Secondary Outcomes (1)

• Secondary (baseline versus final): Lipid panels (Total-C, HDL, LDL, VLDL), lipid ratios , apolipoprotein A and B.

Interventions

Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg) DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes \> 12 months.
• Post-prandial blood glucose (glucose \> 200 mg/dl) levels consistent with an ADA diagnosis of diabetes as confirmed during the screening visit.
• Male and female between the ages of 18 and 65 years.
• HbA1c \> 7.0%.
• Use of treatment regimens including diet and exercise and/or drug therapy for diabetes are allowed. Drug therapy may include alpha-glucosidase inhibitors (e.g. acarbose, voglibose, miglitol) and oral hypoglycemic agents such as sulfonylureas and metformin and thiazolidinediones (TZDs). Insulin use is not allowable
• No changes in medication dosage within 60 days prior to entering trial.
• Subjects with a body mass index (BMI) \>25 and \< 35.
• Fasting triglycerides \< 400. \[32\]
• 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 I diabetes.
• Hypoglycemic event requiring EMS intervention \< 12 months.
• Diabetic Ketoacidosis (DKA) \< 12 months.
• Subjects taking any supplement containing chromium within the previous 90 days prior toenrollment.
• 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 the previous 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 \< 12 months.
• Uncontrolled high blood pressure (seated: systolic \> 160 mmHg or diastolic \> 90 mmHg)
• History of any serious immunosuppressive disorder or undergoing current immunosuppressive therapy.
• Female subjects who are pregnant or nursing, or are planning on becoming pregnant during the study. No hormone replacement therapy for post-menopausal subjects.
• Hepatic disease, impaired thyroid, or impaired renal function, or other diseases known to affect glucose or lipid metabolism. TSH must be within range of normality to enter trial.
• Diagnosed or self-reported alcoholism or substance-abuse problems
• Any psychiatric or mental health issue that would prevent the subject from completing 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.

Sponsors & Collaborators

• Nutrition 21, Inc.: lead

Study Sites (1)

Radiant Research Chicago

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

picolinic acid; Biotin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Jeffery Geohas, MD

  Radiant Research - Chicago

  PRINCIPAL INVESTIGATOR

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: March 27, 2006
• First Posted: March 29, 2006
• Study Start: November 1, 2003
• Study Completion: April 1, 2004
• Last Updated: March 29, 2006

Record last verified: 2006-03

Locations

US (1)