Comparison of Weight Loss Induced by Bariatric Surgery vs Conventional Treatment

Summary

Patients with overweight or obesity are in need to loose weight and represent a particularly challenging medical condition. Undoubtedly, any intervention achieving a negative energy balance over an extended time period will result in weight loss. Although several treatment modalities are available, currently the most extended approaches are lifestyle changes, pharmacotherapy, and bariatric surgery. Given the limited approved anti-obesity drugs, the main therapeutic strategies involve either conventional treatment or bariatric surgery. Conventional weight-reduction programs pursue a safe weight loss rate of 0,5-1,0 kg per week. The main modifiable factors affecting energy balance are dietary energy intake and energy expended through physical activity. In spite of the difficulty in achieving relevant and sustained weight loss via the conventional approach, some patients are successful in reducing weight and obesity-associated complications. Bariatric surgery has proved to be the most effective long-term treatment for weight loss and comorbidity improvement. While some of the surgery-induced benefits are directly dependent on adipose tissue reduction, others are due to specific gastrointestinal changes that take place early on and before any significant effects on body weight are observed. The present study contemplates the determination and comparison of the anthropometric and metabolic changes produced by the conventional and surgery-induced treatment modalities. Particular emphasis will be placed on the potential differential effects between conventional and surgical weight loss on body composition changes, circulating adipokines and gastrointestinal hormones together with their subsequent impact on cardiometabolic risk factors.

Conditions

• Obesity

Interventions

BEHAVIORAL

Lifestyle Changes

Hypocaloric diet providing a 1000 kcal/d deficit from total energy expenditure assessed by indirect calorimetry and physical activity determination. Dietetic and physical activity counselling with a dietitian.

OTHER

Adjustment of oral antidiabetics/insulin therapy

Continuation-discontinuation of medical antidiabetic therapy if needed in accordance with good clinical practice. In addition to the surgery, patients will have regular follow-up with an endocrinologist for appropriate counselling on lifestyle changes (diet, physical activity and vitamin/mineral supplementation counselling) following bariatric surgery as well for adjustment of antidiabetic medication. Adjustment of oral antidiabetics/insulin therapy consisting in continuation, adjustment or discontinuation of medical antidiabetic therapy if needed in accordance with good clinical practice.

PROCEDURE

Laparoscopic sleeve gastrectomy

The Laparoscopic sleeve gastrectomy SG-NG involves the removal of the mayor curvature of the stomach via a laparoscopic approach. In addition to the surgery, patients will have regular follow-up with a dietitian and endocrinologist for appropriate counselling on lifestyle changes (diet, physical activity and vitamin/mineral supplementation counselling) following bariatric surgery.

PROCEDURE

Laparoscopic Roux-en-Y gastric bypass

Laparoscopic Roux-en-Y gastric bypass. In addition to the surgery, patients will have regular follow-up with a dietitian and endocrinologist for appropriate counselling on lifestyle changes (diet, physical activity and vitamin/mineral supplementation counselling) following bariatric surgery.

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Fondo de Investigacion Sanitaria

  collaborator OTHER

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• Gema Frühbeck, MD, PhD · Clinica Universidad de Navarra

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2016-12-31

Completion

2017-12-31

Countries

• Spain

Study Locations