Comparison of Weight Loss Induced by Bariatric Surgery vs Conventional Treatment

NCT ID: NCT01572090

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2017-12-31

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.

Detailed Description

In spite of the recognition of obesity as a serious public health problem due to its well-known increased risk for the development of type 2 diabetes hypertension, coronary heart disease, sleep-breathing disorders, and certain forms of cancer, among others, it is proving extraordinarily difficult to halt this pandemia. Strictly speaking obesity does not refer to an excess weight or weight to height ratio. In fact, the World Health Organization defines obesity as a state of increased adipose tissue of sufficient magnitude to produce adverse health consequences. Thus, in order to better define the effects and benefits of weight loss it is important to address the impact on body fat changes. Given the limited approved anti-obesity drugs, the main therapeutic strategies involve either conventional treatment or bariatric surgery. 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. Noteworthy, currently available bariatric procedures differ on their impact on these aspects. 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 energy intake, energy expenditure, body composition changes, circulating adipokines and gastrointestinal hormones together with their subsequent impact on cardiometabolic risk factors. The conventional weight-reduction program (CONV) will pursue a safe weight loss rate of 0,5-1,0 kg per week. The surgery-induced weight loss will be achieved by two of the most frequently used bariatric operations, the sleeve gastrectomy [SG (which implies a restrictive component)] and the Roux-en-Y gastric bypass [RYGB (which combines a restrictive and a malabsorptive component)].

The purpose of the study is to determine the effect of three weight loss procedures that differ on their manipulation of the anatomical and functional characteristics of the gastrointestinal tract. While in the conventional treatment the gastrointestinal system remains intact, in the SG only the stomach is manipulated as opposed to the RYGB, where both the stomach and the small intestine are operated on. Since bariatric surgery is well known to induce partial or total remission of type 2 diabetes mellitus, the effects of the three different weight loss procedures will be assessed separately in obese normoglycemic and obese type 2 diabetic individuals.

Conditions

Obesity

Keywords

Body mass index; Body fat; Obesity; Bariatric surgery; Conventional dietary treatment; Diabetes Mellitus, Type 2; Cardiometabolic risk factors; Inflammation; Adipokines; Gastrointestinal hormones; Comorbidity improvement; Energy intake; Energy expenditure; Physical activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Conventional weight loss: CONV-NG

Obese 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.

Group Type: ACTIVE_COMPARATOR

Lifestyle Changes

Intervention Type: BEHAVIORAL

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.

Conventional weight loss: CONV-T2D

Obese 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.

Group Type: ACTIVE_COMPARATOR

Lifestyle Changes

Intervention Type: BEHAVIORAL

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.

Adjustment of oral antidiabetics/insulin therapy

Intervention Type: OTHER

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.

Laparoscopic Sleeve gastrectomy: SG-NG

The 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.

Group Type: ACTIVE_COMPARATOR

Lifestyle Changes

Intervention Type: BEHAVIORAL

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.

Laparoscopic sleeve gastrectomy

Intervention Type: PROCEDURE

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 Sleeve gastrectomy: SG-T2D

The 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.

Group Type: ACTIVE_COMPARATOR

Lifestyle Changes

Intervention Type: BEHAVIORAL

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.

Adjustment of oral antidiabetics/insulin therapy

Intervention Type: OTHER

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.

Laparoscopic sleeve gastrectomy

Intervention Type: PROCEDURE

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 R-Y gastric bypass: RYGB-NG

The 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.

Group Type: ACTIVE_COMPARATOR

Lifestyle Changes

Intervention Type: BEHAVIORAL

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.

Laparoscopic Roux-en-Y gastric bypass

Intervention Type: PROCEDURE

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.

Laparoscopic R-Y gastric bypss: RYGB-T2D

The 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.

Group Type: ACTIVE_COMPARATOR

Lifestyle Changes

Intervention Type: BEHAVIORAL

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.

Adjustment of oral antidiabetics/insulin therapy

Intervention Type: OTHER

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.

Laparoscopic Roux-en-Y gastric bypass

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Conventional weight loss; Pharmacological treatment adjustment; Restrictive bariatric surgery; Laparoscopic sleeve gastrectomy SG; Mixed (restrictive & malabsorptive) bariatric surgery

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Gema Frühbeck Martínez

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gema Frühbeck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinica Universidad de Navarra

Locations

Clinica Universidad de Navarra

Pamplona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 28187933 (View on PubMed)

Gomez-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.

Reference Type: DERIVED

PMID: 27188262 (View on PubMed)

Other Identifiers

OBECUN-WL-01

Identifier Type: -

Identifier Source: org_study_id