Clinical Studies

Clinical Research at St. Luke's - Roosevelt

Study name:Treatment of Diabetes After Gastric Bypass Surgery with Sitagliptin (IRB# 11-156)

Purpose of study: Analyze the effect of sitagliptin (Januvia®), an FDA approved medication, for the treatment of type 2 diabetes in patients after gastric bypass surgery

Principal investigator: Blandine Laferrère, MD

Co-investigators:James McGinty, MD; Scott Belsley, MD; Aastha Pal, MD; Sinan Altiner, MD

Summary: Participants will come in to the research center for two half day research visits and two 1-hour research visits over 6-8 weeks. Participants will either take sitagliptin (Januvia®) or a placebo pill for 4-6 weeks. The four visits completed at the research center are as follows:

  • Day 1: Initial Screening
  • Day 2: A 4- hour Meal test with IV
  • Day 3: Midway Check-In Appointment for questionnaires (about 1 hour)
  • Day 4: A second 4-hour meal test with IV

Participants can learn about their diabetes status, see whether the medication could be of any benefit to treat diabetes, and get nutritional and diabetes education and materials. $300 in compensation will be given.

Eligibility Criteria: Potential participants have had gastric bypass surgery at least 1 year ago, and were diagnosed with type 2 diabetes before gastric bypass surgery. Participants must have a current Hba1c> 6.4% and/or fasting blood glucose (sugar) > 125 mg/dl and should be able and willing to check glucose by finger sticks.

Study site location: New York Obesity Nutrition Research Center, St. Luke’s Hospital, 1111 Amsterdam Avenue at 114th Street, New York, NY 10025

Contact Information: Call Margaret Sala at 212-523-3503 or Carolina Espinosa at 212-523-3581.

 

Study name: Diabetes after Weight Loss Surgery (IRB# 03-108)

Purpose of study: This study analyzes the role of gut peptides -- small proteins that play a role in stimulating insulin during meals -- on insulin secretion, insulin sensitivity and blood glucose levels in individuals with diabetes, before and after surgical weight loss by gastric banding.

Principal investigator: Blandine Laferrère, MD

Co-investigators: James McGinty, MD; Ninan Koshy, MD; Eugenius Harvey, MD; Scott Belsley, MD

Summary: Participants will be examined during four study periods: before gastric banding surgery, then one month after surgery, and then one year and two years after surgery. During each study period, participants will make three separate visits in the morning to the research center for various glucose challenge tests and body composition measurements. These visits will last for about four hours. Partial compensation is provided to participants at the end of each study period. Total compensation for completing the two-year study is up to $1,950.

Eligibility criteria: Potential subjects are patients with obesity and diabetes who have chosen to have gastric banding surgery and have been approved by their surgeon to have gastric banding. Subjects must have a BMI above 35 kg/m2. They must also have health insurance coverage for routine medical and surgical care.

Study site location: New York Obesity Nutrition Research Center, St. Luke’s Hospital, 1111 Amsterdam Avenue at 114th Street, New York, NY 10025

Contact information: For more information, Call Carolina Espinosa at 212-523-3581 or Margaret Sala at 212-523-3503.