Weight Loss Study for People With Type 2 Diabetes

Exclusion Criteria

• •1. Type 1 Diabetes
• •2. Cardiovascular/Coronary Heart Disease \[e.g., MI or CVA within last 6 months, TIA, clinically significant arrhythmias, uncontrolled hypertension (defined as blood pressure over 160/110); physician's discretion may be more conservative\]
• •3. Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode
• •4. Taking prescription or OTC weight loss medications within last 4 weeks
• •5. Currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti-psychotics)
• •6. Within the last 4 weeks, use of chromium supplements or any nutrition supplements or herbal products claimed to have a weight loss effect. Participants using other non-excluded nutrition supplements or herbal products must agree to continue at their current level of use throughout the study.
• •7. Participation in a weight control program within the past 3 months
• •8. QTc interval \>450 msec for males and QTc interval \>470 msec for females
• •9. PHQ-9 total score \> 15
• •10. Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable
• •11. History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
• •12. History of major surgery within three months of enrollment
• •13. Presence of implanted cardiac defibrillator
• •14. Orthopedic limitations that would interfere with ability to engage in regular physical activity
• •15. Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease
• •16. Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment was completed more than 6 months prior to enrollment.
• •17. History, within the past five years, of clinically diagnosed eating disorders Confidential March 30, 2012 9 including anorexia nervosa or bulimia nervosa.
• •18. Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control
• •19. Participation in another clinical trial within 30 days prior to enrollment.
• •20. Currently consuming \>14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per drinking day during study participation
• •21. Current or past drug abuse
• •22. Participation in trial by another member of household
• •23. Hypoglycemic Events:
• •a. Evidence of more than 1 severe hypoglycemic event in the past 12 months, unless the participant's treating physician provides written clearance for participation.
• •24. Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial -