Overview

Weight Loss With Intensive Lifestyle Modifications Plus Bariatric Surgery Versus Liraglutide 3 mg

Status:
Completed
Trial end date:
2017-04-10
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Catholic University of the Sacred Heart
Treatments:
Liraglutide
Criteria
Inclusion Criteria:

Age ranging from 18 to 70 years, stable body weight in the previous 6 months body mass
index (BMI expressed in kg/m2) >35 if comorbidity (hypertension, sleep apnea, severe hip or
knee arthritis) are present or >40 kg/m2.

Exclusion Criteria:

Type 1 or 2 diabetes, previous bariatric surgery, a history of pancreatitis, a history of
major depressive or other severe psychiatric disorders, a family or personal history of
multiple endocrine cancer type 2 or familial medullary thyroid carcinoma.