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

March 27, 2006 updated by: Nutrition 21, Inc.

"A Randomized, Double Blinded, Placebo Controlled, Parallel Arm, Study to Evaluate the Improvement in Glycemic Control After Daily Administration of Chromium Picolinate and Biotin in Patients With Type 2 Diabetes Mellitus"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this 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 who are currently taking an oral antidiabetic agent (OAD) and failing therapy with OADs. Subjects entering the trial must have a HbA1c >/= 7.0% and have an OGTT >/= 200 mg/dL at 2 hours post consumption of a 75 g glucose beverage. The study is an acute 30 day intervention in conjunction with the subject's current OADs and standard of care in comparison to placebo.

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 as measured by the area under the curve for glucose (AUCg). The study will also assess the acute effects of supplementation over a 4-week period (relative to placebo) on fasting plasma levels of glucose, fructosamine, insulin, lipids and lipoproteins.

Study Type

Interventional

Enrollment

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Radiant Research Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of type 2 diabetes > 12 months.
  2. Post-prandial blood glucose (glucose > 200 mg/dl) levels consistent with an ADA diagnosis of diabetes as confirmed during the screening visit.
  3. Male and female between the ages of 18 and 65 years.
  4. HbA1c > 7.0%.
  5. 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
  6. No changes in medication dosage within 60 days prior to entering trial.
  7. Subjects with a body mass index (BMI) >25 and < 35.
  8. Fasting triglycerides < 400. [32]
  9. Willing to complete all study related requirements.
  10. Subject will provide written consent to participate in the trial and this consent must be given voluntarily.

Exclusion Criteria:

  1. Diagnosis of type I diabetes.
  2. Hypoglycemic event requiring EMS intervention < 12 months.
  3. Diabetic Ketoacidosis (DKA) < 12 months.
  4. Subjects taking any supplement containing chromium within the previous 90 days prior toenrollment.
  5. Creatinine > 2.0 x ULN; AST or ALT > 2.0 x ULN; Total Bilirubin > 1.5 x ULN.
  6. COPD, CHF, Angina, HTN, MI, or any other CVD requiring hospitalization within the previous 12 months.
  7. History of cerebrovascular accident (CVA), pulmonary embolism (PE), or an unresolved deep vein thrombosis (DVT).
  8. History of CABG, PTCA, or any other reperfusion therapy < 12 months.
  9. Uncontrolled high blood pressure (seated: systolic > 160 mmHg or diastolic > 90 mmHg)
  10. History of any serious immunosuppressive disorder or undergoing current immunosuppressive therapy.
  11. Female subjects who are pregnant or nursing, or are planning on becoming pregnant during the study. No hormone replacement therapy for post-menopausal subjects.
  12. 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.
  13. Diagnosed or self-reported alcoholism or substance-abuse problems
  14. Any psychiatric or mental health issue that would prevent the subject from completing the study
  15. 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.
  16. Current participation in any other clinical research trial for any product or device, or participation in said clinical trials within 30 days prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutrition 21, Inc.

Investigators

  • Principal Investigator: Jeffery Geohas, MD, Radiant Research - Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 29, 2006

Study Record Updates

Last Update Posted (Estimate)

March 29, 2006

Last Update Submitted That Met QC Criteria

March 27, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N21 CPB-03001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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