Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects

Obese subjects (body mass index ≥ 30 kg/m2) with prediabetes or type 2 diabetes will be recruited by solicitation flyers, advertisements, and mass emails. Subjects who do not qualify for bariatric surgery, or subjects who are awaiting insurance approval for a bariatric procedure at the Center of Surgical Weight Loss at Vanderbilt University Medical Center will also be contacted via emails and telephone calls. Subjects will be directed to contact the researcher (Drs. Abumrad and Sundaresan) directly for more information. The recruiter will review inclusion and exclusion criteria and explain the study procedures, duration of the study and potential risks. If the subject indicates interest, screening will be performed to determine eligibility.

Subjects will undergo an initial screen by the study coordinator or research staff to assess eligibility and ability to comply with the study requirements. Prior to each study visit, subjects on oral anti-diabetic medications will be asked to discontinue these medications 4 days prior to their study visit. Diabetic subjects will be instructed to monitor their pre-prandial blood glucose during this time and to contact the study physician if their blood glucose levels are greater than 250 mg/dL for two consecutive readings. The study physician may instruct the subject to initiate short-term insulin therapy or resume their oral anti-diabetic medications; in either case the subject will be excluded from the study. Subjects will be instructed to maintain their usual diet and physical activity levels for 1 week prior to each study visit and to arrive fasted for every visit (only water after dinner).

6. Study Procedures

The subjects will be recruited for 5 study visits. After informed, written consent is obtained, subjects will be admitted to the Clinical Research Center.

Study visit 1: