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Clinical Trial Details

Trial ID: L6909
Source ID: NCT01512797
Associated Drug: Sitagliptin Phosphate
Title: Treatment of Diabetes After Gastric Bypass With Sitagliptin
Acronym: LAF33
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01512797/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin phosphate|OTHER: Placebo
Outcome Measures: Primary: Change in Postprandial Glucose Levels After Mixed Meal Test, Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo)., Baseline and ~4 weeks|Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test, Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo). AUC was measured by trapezoidal method., Baseline and ~4 weeks | Secondary: Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery, Satiety levels were measured in study participants while they were fasting and periodically over a three hour period after drinking a 200 kcal meal drink, before and after intervention via a Visual Analog Scale. Participants were asked to mark on a 0 to 150 millimeter scale their response to the following question: "How full do you feel right now?" with lower scores indicating "not full at all" and higher scores indicating "extremely full.", Baseline and ~4 weeks|Occurrence of Side Effects In Relation to Sitagliptin, Side effects to Sitagliptin or Placebo were measured in study participants via Sigstad score questionnaire, while fasting and periodically during a 3 hour period after drinking a 200 kcal meal drink, before and after intervention. The Sigstad scoring system is based on the participants report of the occurrence of 16 symptoms suggestive of the dumping syndrome. Each symptom is given a different score. For example, desire to sit down (+4), breathlessness (+3), dizziness (+2), nausea (+1), vomiting (-4) etc.The scale can range from -5 to 34. Scores greater than or equal to 7, after glucose intake, are considered diagnostic of dumping syndrome., 6 weeks|Active GLP-1, Active GLP-1 (Fasting and during a Mixed Meal Test). The Change in Fasting Active GLP-1 refers to the change in fasting active GLP-1 from pre-intervention time point to post-intervention time point. The Change in Peak Active GLP-1 refers to the change in the peak active GLP-1 level from the pre-intervention time point to post-intervention time point., Pre-Intervention and Post-Intervention
Sponsor/Collaborators: Sponsor: Blandine Laferrere | Collaborators: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 37
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-07
Completion Date: 2016-08
Results First Posted: 2018-02-23
Last Update Posted: 2019-01-22
Locations: New York Obesity Nutrition Research Center, Columbia University, New York, New York, 10032, United States
URL: https://clinicaltrials.gov/show/NCT01512797