Comparison of Weight Loss Induced by Bariatric Surgery vs Conventional Treatment
1 other identifier
interventional
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jan 2006
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 28, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 26, 2016
October 1, 2016
10.9 years
March 28, 2012
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body fat
Body fat will be assessed by air-displacement plethysmography (Bod-Pod) over the duration of the intervention.
Baseline, 1, 6, 12, and 24 months
Secondary Outcomes (6)
Change in energy balance
Baseline, 1, 6, 12 and 24 months
Change in glycemic control
Baseline, 1, 6, 12 and 24 months
Change in cardiovascular risk factors
Baseline, 1, 6, 12 and 24 months
Change in gastrointestinal hormones
Baseline, 1, 6, 12 and 24 months
Change in gustatory threshold
Baseline, 1, 6, 12 and 24 months
- +1 more secondary outcomes
Study Arms (6)
Conventional weight loss: CONV-NG
ACTIVE COMPARATORObese normoglycemic (NG) patients evidenced by a body fat ≥ 35% in women and ≥ 25% in men and a 2-h oral glucose tolerance test. Conventional weight loss will be achieved by "Lifestyle changes" including advice on increasing physical activity and prescription of a hypocaloric diet providing a daily energy deficit of 500-1000 kcal/d as calculated from the determination of the resting energy expenditure through indirect calorimetry (Vmax29, SensorMedics Corporation, Yorba Linda, CA) and multiplication by the physical activity level factor to obtain the individual's total energy expenditure. Regular visits with the dietitian will be scheduled as in the surgical groups.
Conventional weight loss: CONV-T2D
ACTIVE COMPARATORObese type 2 diabetic (T2D) patients evidenced by a body fat \>35% in women and ≥ 25% in men and proven documentation of T2D diagnosis, history and treatment in accordance with good clinical practice. Conventional weight loss will be achieved by "Lifestyle changes" including advice on increasing physical activity and prescription of a hypocaloric diet providing a daily energy deficit of 500-1000 kcal/d as calculated from the determination of the resting energy expenditure through indirect calorimetry (Vmax29, SensorMedics Corporation, Yorba Linda, CA) and multiplication by the physical activity level factor to obtain the individual's total energy expenditure. Regular visits with the dietitian will be scheduled as in the surgical groups.
Laparoscopic Sleeve gastrectomy: SG-NG
ACTIVE COMPARATORThe intervention in this arm comprises obese (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities) normoglycemic (NG) patients (evidenced by a 2-h OGTT) undergoing a sleeve gastrectomy (SG). The 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.
Laparoscopic Sleeve gastrectomy: SG-T2D
ACTIVE COMPARATORThe intervention in this arm comprises obese (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities) type 2 diabetic (T2D) patients with proven documentation of T2D diagnosis, history and treatment in accordance with good clinical practice undergoing a sleeve gastrectomy (SG). 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 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.
Laparoscopic R-Y gastric bypass: RYGB-NG
ACTIVE COMPARATORThe intervention in this arm comprises obese (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities) normoglycemic (NG) patients (evidenced by a 2-h OGTT) undergoing laparoscopic Roux-en-Y gastric bypass (RYGB). 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.
Laparoscopic R-Y gastric bypss: RYGB-T2D
ACTIVE COMPARATORThe intervention in this arm comprises obese (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities) type 2 diabetic (T2D) patients with proven documentation of T2D diagnosis, history and treatment in accordance with good clinical practice undergoing laparoscopic Roux-en-Y gastric bypass (RYGB). 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 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Age between 21 and 65 years.
- Obesity as defined by World Health Organization criteria.
- For bariatric surgery patients: qualified for obesity surgery by the -Multidisciplinary Obesity Team of the Clinica Universidad de Navarra
- For type 2 diabetic patients: T2D diagnosis confirmed by either fasting plasma glucose ≥126 mg/dL on two separate occasions, or fasting plasma glucose ≥126 mg/dL and plasma glucose ≥140 mg/dL 2 h after OGTT, or treatment with anti-diabetic medication in accordance with good clinical practice with and well-documented information on diagnosis, history, treatment(s) and HbA1c data.
- No major organ disease unrelated to excess body weight.
- Mentally able to understand the study and willingness to participate in the study.
You may not qualify if:
- Pregnancy/lactation
- Poor overall general health
- Drug and/or alcohol addiction
- Prior bariatric or gastrointestinal surgery
- Active gastric or intestinal tract disease
- Thyroid disease
- Type 1 diabetes mellitus
- Portal hypertension and/or cirrhosis
- Malignancies
- History of eating disorders or major psychiatric illness
- Unable to communicate with study staff
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica Universidad de Navarra
Pamplona, Spain
Related Publications (2)
Gomez-Ambrosi J, Gonzalez-Crespo I, Catalan V, Rodriguez A, Moncada R, Valenti V, Romero S, Ramirez B, Silva C, Gil MJ, Salvador J, Benito A, Colina I, Fruhbeck G. Clinical usefulness of abdominal bioimpedance (ViScan) in the determination of visceral fat and its application in the diagnosis and management of obesity and its comorbidities. Clin Nutr. 2018 Apr;37(2):580-589. doi: 10.1016/j.clnu.2017.01.010. Epub 2017 Jan 28.
PMID: 28187933DERIVEDGomez-Ambrosi J, Gallego-Escuredo JM, Catalan V, Rodriguez A, Domingo P, Moncada R, Valenti V, Salvador J, Giralt M, Villarroya F, Fruhbeck G. FGF19 and FGF21 serum concentrations in human obesity and type 2 diabetes behave differently after diet- or surgically-induced weight loss. Clin Nutr. 2017 Jun;36(3):861-868. doi: 10.1016/j.clnu.2016.04.027. Epub 2016 May 4.
PMID: 27188262DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gema Frühbeck, MD, PhD
Clinica Universidad de Navarra
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
March 28, 2012
First Posted
April 5, 2012
Study Start
January 1, 2006
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
October 26, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share