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

Sponsor
Catholic University of the Sacred Heart
Study ID
NCT03534310
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 2, 2015
Status verified
May 2018
Primary completion
Jan 31, 2017
Completion
Apr 10, 2017

Study Design

Enrollment
75 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Lifestyle modification
    1 month of a VLCD with 865 kcal per day followed by a 12 kcal per kg of body weight of a high-protein, high fat diet for 11 months in association with intensive
  • Experimental: Lifestyle modification plus Liraglutide 3 mg
    1 month of a VLCD with 865 kcal per day followed by a 12 kcal per kg of body weight of a high-protein, high fat diet for 11 months in association with intensive. The patients will also receive Liraglutide 3 mg daily sc.
  • Active Comparator: Sleeve Gastrectomy
    The patients will undergo laparoscopic sleeve gastrectomy

Primary Outcome Measure

Change of baseline BMI [ Time Frame: 1 year ]

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