Status:
COMPLETED
A 30 Day Acute Efficacy and Safety Study of Chromium Picolinate + Biotin on Glycemic Control in Overweight or Obese Subjects With T2DM
Lead Sponsor:
Nutrition 21, Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
NA
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 i...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00308451
Start Date
November 1 2003
End Date
April 1 2004
Last Update
March 29 2006
Active Locations (1)
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1
Radiant Research Chicago
Chicago, Illinois, United States, 60610