ObesityNCT01572090
Comparison of Weight Loss Induced by Bariatric Surgery vs Conventional Treatment
A study testing Lifestyle Changes, Adjustment of oral antidiabetics/insulin therapy and Laparoscopic sleeve gastrectomy in people with Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle Changes, Adjustment of oral antidiabetics/insulin therapy and Laparoscopic sleeve gastrectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy/lactation
- Poor overall general health
- Drug and/or alcohol addiction
- Prior bariatric or gastrointestinal surgery
- Active gastric or intestinal tract disease
- Thyroid disease
Show all 11Show fewer
- Type 1 diabetes mellitus
- Portal hypertension and/or cirrhosis
- Malignancies
- History of eating disorders or major psychiatric illness
- Unable to communicate with study staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Weight Loss Induced by Bariatric Surgery vs Conventional Treatment on Body Composition, Adipokines, Gastro-intestinal Hormones and Cardiometabolic Risk Factors
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.
Read the 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
- Being tested
- Lifestyle Changes, Adjustment of oral antidiabetics/insulin therapy, Laparoscopic sleeve gastrectomy, Laparoscopic Roux-en-Y gastric bypass
- 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
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ChangesBehavioural
Also called Conventional weight loss
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 therapyOther
Also called Pharmacological treatment adjustment
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 gastrectomyProcedure or surgery
Also called Restrictive bariatric surgery, Laparoscopic sleeve gastrectomy SG
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 bypassProcedure or surgery
Also called Mixed (restrictive & malabsorptive) 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional weight loss: CONV-NG | Active comparator | 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. Receives: Behavioral: Lifestyle Changes |
| Conventional weight loss: CONV-T2D | Active comparator | 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. Receives: Behavioral: Lifestyle Changes; Other: Adjustment of oral antidiabetics/insulin therapy |
| Laparoscopic Sleeve gastrectomy: SG-NG | Active comparator | 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. Receives: Behavioral: Lifestyle Changes; Procedure: Laparoscopic sleeve gastrectomy |
| Laparoscopic Sleeve gastrectomy: SG-T2D | Active comparator | 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. Receives: Behavioral: Lifestyle Changes; Other: Adjustment of oral antidiabetics/insulin therapy; Procedure: Laparoscopic sleeve gastrectomy |
| Laparoscopic R-Y gastric bypass: RYGB-NG | Active comparator | 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. Receives: Behavioral: Lifestyle Changes; Procedure: Laparoscopic Roux-en-Y gastric bypass |
| Laparoscopic R-Y gastric bypss: RYGB-T2D | Active comparator | 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. Receives: Behavioral: Lifestyle Changes; Other: Adjustment of oral antidiabetics/insulin therapy; Procedure: Laparoscopic Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat
Body fat will be assessed by air-displacement plethysmography (Bod-Pod) over the duration of the intervention.
Measured: Baseline, 1, 6, 12, and 24 months
Secondary outcomes (6)
Change in energy balance
Energy intake will be assessed by food dietary, 24-h recall, FFQ and energy expenditure will be determined by indirect calorimetry, physical activity questionnaires and accelerometry over the duration of the intervention.
Measured: Baseline, 1, 6, 12 and 24 months
Change in glycemic control
Measurement of fasting plasma glucose, insulin and HbA1c concentrations over the duration of the intervention.
Measured: Baseline, 1, 6, 12 and 24 months
Change in cardiovascular risk factors
Measurement of circulating total cholesterol, LDL-cholesterol, HDL-cholesterol, fibrinogen, C-reactive protein, homocysteine, von Willebrand factor and adipokines over the duration of the intervention.
Measured: Baseline, 1, 6, 12 and 24 months
Change in gastrointestinal hormones
Measurement of fasting ghrelin, PYY, GLP-1, GIP, PP, amylin and oxyntomodulin over the duration of the intervention.
Measured: Baseline, 1, 6, 12 and 24 months
Change in gustatory threshold
Determination of the gustatory threshold levels by the whole-mouth chemical test procedure and tongue electrogustometry over the duration of the intervention.
Measured: Baseline, 1, 6, 12 and 24 months
Change in BMI
Measurement of weight and height over the duration of the intervention to calculate the BMI.
Measured: Baseline, 1, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startJan 2006
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria
- Responsible party
- Principal investigator, Gema Frühbeck Martínez, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Gema Frühbeck, MD, PhD, Principal investigator, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572090
- Sponsor's protocol ID
- OBECUN-WL-01
- Status last verified
- Oct 2016
- First submitted
- 28 Mar 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28187933Gomez-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.
PubMed 27188262
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Weight Loss Induced by Bariatric Surgery vs Conventional Treatment on Body Composition, Adipokines, Gastro-intestinal Hormones and Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT01572090
- Acronym / sponsor ID
- OBECUN-WL-01
- Conditions
- Obesity
- Keywords
- Body mass index, Body fat, Obesity, Bariatric surgery, Conventional dietary treatment, Diabetes Mellitus, Type 2, Cardiometabolic risk factors, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria
- Study start
- Jan 2006
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Conventional weight loss: CONV-NG | Active comparator | Behavioral: Lifestyle ChangesObese 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 comparator | Behavioral: Lifestyle Changes, Other: Adjustment of oral antidiabetics/insulin therapyObese 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 comparator | Behavioral: Lifestyle Changes, Procedure: Laparoscopic sleeve gastrectomyThe 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 comparator | Behavioral: Lifestyle Changes, Other: Adjustment of oral antidiabetics/insulin therapy, Procedure: Laparoscopic sleeve gastrectomyThe 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 comparator | Behavioral: Lifestyle Changes, Procedure: Laparoscopic Roux-en-Y gastric bypassThe 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 comparator | Behavioral: Lifestyle Changes, Other: Adjustment of oral antidiabetics/insulin therapy, Procedure: Laparoscopic Roux-en-Y gastric bypassThe 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- Pregnancy/lactation
- Poor overall general health
- Drug and/or alcohol addiction
- Prior bariatric or gastrointestinal surgery
- Active gastric or intestinal tract disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ChangesAlso: Conventional weight lossHypocaloric 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. | Behavioural | Conventional weight loss: CONV-NG, Conventional weight loss: CONV-T2D, Laparoscopic R-Y gastric bypass: RYGB-NG, Laparoscopic R-Y gastric bypss: RYGB-T2D, Laparoscopic Sleeve gastrectomy: SG-NG, Laparoscopic Sleeve gastrectomy: SG-T2D |
| Adjustment of oral antidiabetics/insulin therapyAlso: Pharmacological treatment adjustmentContinuation-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. | Other | Conventional weight loss: CONV-T2D, Laparoscopic R-Y gastric bypss: RYGB-T2D, Laparoscopic Sleeve gastrectomy: SG-T2D |
| Laparoscopic sleeve gastrectomyAlso: Restrictive bariatric surgery, Laparoscopic sleeve gastrectomy SGThe 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 or surgery | Laparoscopic Sleeve gastrectomy: SG-NG, Laparoscopic Sleeve gastrectomy: SG-T2D |
| Laparoscopic Roux-en-Y gastric bypassAlso: Mixed (restrictive & malabsorptive) bariatric surgeryLaparoscopic 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. | Procedure or surgery | Laparoscopic R-Y gastric bypass: RYGB-NG, Laparoscopic R-Y gastric bypss: RYGB-T2D |
Primary outcome
Change in body fat
Time frame: Baseline, 1, 6, 12, and 24 months
Body fat will be assessed by air-displacement plethysmography (Bod-Pod) over the duration of the intervention.
6 secondary outcomes
Change in energy balance
Time frame: Baseline, 1, 6, 12 and 24 months
Change in glycemic control
Time frame: Baseline, 1, 6, 12 and 24 months
Change in cardiovascular risk factors
Time frame: Baseline, 1, 6, 12 and 24 months
Change in gastrointestinal hormones
Time frame: Baseline, 1, 6, 12 and 24 months
Change in gustatory threshold
Time frame: Baseline, 1, 6, 12 and 24 months
Change in BMI
Time frame: Baseline, 1, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 28187933Gomez-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.
- Derived from this study: PubMed 27188262Gomez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gema Frühbeck, MD, PhD principal investigator
Clinica Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Changes, Adjustment of oral antidiabetics/insulin therapy and Laparoscopic sleeve gastrectomy in people with Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body fat (time frame: Baseline, 1, 6, 12, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572090, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.