Conditions: Type 2 Diabetes Mellitus
Keywords: Januvia Sitagliptin Diabetes Gastric-Bypass
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.

Detailed description:
Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type 2 Diabetes. Sitagliptin works by inhibiting the Dipeptidyl peptidase-4 enzyme, resulting in increased active glucagon-like peptide-1 (GLP-1) levels. GLP-1 is an incretin which increases post-prandial insulin secretion. Because Gastric Bypass has also been shown to increase GLP-1 levels, this study seeks to determine the additional effect of DDP-4 inhibition on glucose control in patients who have elevated incretin levels post Gastric Bypass. The study will also assess if Januvia (Sitagliptin phosphate) is safe and well tolerated in patients after Gastric Bypass.

Recruitment and data collection for this study was started at St. Luke's Hospital in New York, NY and later moved to Columbia University Medical Center in New York, NY.

Arms:
arm 1: 100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks arm 2: 1 Placebo pill / day PO once a day for 4-5 weeks

Interventions: intervention 1: Sitagliptin phosphate intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg/day orally intervention 2: 1 Placebo Pill per day

Protocol document: