Weight Loss With Intensive Lifestyle Modifications Plus Bariatric Surgery Versus Liraglutide 3 mg
Status:
Completed
Trial end date:
2017-04-10
Target enrollment:
Participant gender:
Summary
Background/Objectives: Only 1% of the clinically eligible subjects receive surgical treatment
for their obesity, thus other options should be investigated. In this study we aim to assess
the effect of intensive-lifestyle-modification(ILM) with or without Liraglutide-3mg daily
versus sleeve-gastrectomy(SG) on BMI at 1-year.
Subjects/Methods: In this study performed in a University Hospital in Italy, non-diabetic
patients eligible for bariatric-surgery are recruited from the weight loss clinic and have
the option to choose within three possible weight-loss programs up to complete the allocation
of 25 subjects in each arm matched by BMI and age. ILM consists in 600kcal
very-low-calorie-diet(VLCD) for 1 month followed by 12kcal/kgbw high-protein, high-fat-diet
for 11 months plus 30minutes brisk-walk daily and at least 3 hours aerobic-exercise weekly.
SG patients have 1-month VLCD and free-diet thereafter. Patients are evaluated at baseline
and at 1,3,6,9 and 12months.