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

This study has been completed.
Sponsor:
Information provided by:
Nutrition 21, Inc.
ClinicalTrials.gov Identifier:
NCT00308451
First received: March 27, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: ”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”

Resource links provided by NLM:


Further study details as provided by Nutrition 21, Inc.:

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

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

Estimated Enrollment: 40
Study Start Date: November 2003
Estimated Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308451

Locations
United States, Illinois
Radiant Research Chicago
Chicago, Illinois, United States, 60610
Sponsors and Collaborators
Nutrition 21, Inc.
Investigators
Principal Investigator: Jeffery Geohas, MD Radiant Research - Chicago
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00308451     History of Changes
Other Study ID Numbers: N21 CPB-03001
Study First Received: March 27, 2006
Last Updated: March 27, 2006
Health Authority: United States: US FDA (DSHEA)
United States: New England IRB

Keywords provided by Nutrition 21, Inc.:
chromium
chromium picolinate
type 2 diabetes mellitus
fructosamine
glycemic control
OGTT

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biotin
Chromium
Picolinic acid
Chelating Agents
Growth Substances
Iron Chelating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sequestering Agents
Trace Elements
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 21, 2014