Weight Loss With Intensive Lifestyle Modifications Plus Bariatric Surgery Versus Liraglutide 3 mg
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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.
    

Detailed description: 
      Obesity is associated with major chronic diseases, including type 2 diabetes (T2D) and
      cardiovascular disease (CVD) 1-3. The number of subjects affected by morbid obesity or class
      III obesity (BMI≥40 kg/m2) is rapidly increasing 4 and contributed to 20% of the total per
      capita health-care expenditures in 2000 in the United States 5 .

      Subjects with a body mass index (BMI) >40 kg/m2 or >35 kg/m2 in the presence of obesity
      complications are eligible for bariatric surgery 6 . The mortality rate after bariatric
      surgery is low, being 0.08% within 30 days and 0.31% after 30 days 7, and bariatric surgery
      has shown many health benefits including reduction of long term mortality 8 and type 2
      diabetes remission (T2D) 9-11., However, due to the perception that bariatric surgery is a
      risky procedure among the general public and insurance companies or other health care
      providers only 1% of the clinically eligible subjects receive surgical treatment for their
      obesity 12.

      The largest portion of patients eligible for bariatric surgery but who are not willing to be
      operated or cannot undergo surgery for other reasons should be offered, however, with other
      therapeutic options. To this end a pilot study to determine the efficacy of an intensive
      lifestyle modification (ILM) with or without 3 mg daily Liraglutide versus bariatric surgery
      with free diet and free physical activity was designed. In the medical arms the patients were
      also invited to contact the dietitian and the physician every week by email or by phone to
      assure a tight weight control. The allocation of the patients, all of them eligible for
      bariatric surgery, was on a voluntary basis, i.e. they were invited to decide their
      allocation in one of the 3 arms of the study matched by BMI and age.

      Liraglutide, a glucagon-like peptide-1 analog, approved for the treatment of obesity at the
      dose of 3 mg per day and commercialized under the name of Saxenda, was proved to reduce body
      weight after 56 weeks by 8.4±7.3 kg as compared with a mean of 2.8±6.5 kg in the patients
      under placebo 13 . Importantly, the weight reduction is maintained up to 3 years as shown by
      LeRoux et al. 14.

      However, this degree of weight loss is generally considered insufficient by patients who
      would like to be considered for bariatric surgery.

      A 12 week VLCD was reported to allow a weight reduction of about 20 kg in men and of near 16
      kg in women 15. However, the weight-reducing effect of a VLCD is temporary and must be
      combined with other methods to maintain the weight loss. Low-carbohydrate, high-fat,
      high-protein diet is associated with a relevant weight loss and elevated satiating effects as
      well as with maintenance or accretion of lean body mass 16,17.

      In this study it was hypothesized that a VLCD for 1 month might match in the two medical arms
      the weight loss reached with SG, thus giving more motivation to the patients to continue the
      diet. The aim of the study is to find other avenues than bariatric surgery to treat obese
      patients obtaining a relevant weight loss that can satisfy morbidly obese subjects.

      Therefore, this trial included a VLCD for the first month in order to match the diet usually
      prescribed after bariatric surgery and the following diet will be a low-carbohydrate,
      high-fat, high-protein diet to achieve a substantial weight loss.

      Among the surgical procedures sleeve gastrectomy (SG) was chosen since it has increased
      markedly in the past few years and has earned a place as a primary bariatric surgery 18.
    

Intervention name(s): LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML); lifestyle modification; sleeve gastrectomy
Intervention type(s): Drug; Other; Other
Intervention MeSH terms: Liraglutide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: lifestyle modification alone, lifestyle modification and Liraglutide 3 mg daily, sleeve gastrectomy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; sleeve-gastrectomy; liraglutide; Weight-loss