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

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.