Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention

Obesity Clinical Trial

— WAS  

Official title:

Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention Wurzburg Adipositas Study - WAS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352403
• Other study ID #: 2008-005054-20
• Status: Completed
• Phase: N/A
• Start date: July 4, 2011
• Est. completion date: January 28, 2019

Study information

• Verified date: February 2023
• Source: University of Wuerzburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of weight loss induced by gastric bypass surgery in comparison to a psychotherapy-enhanced lifestyle intervention on cardiopulmonary performance and quality of life in patients with morbid obesity.

Description:

Obesity is a rapidly emerging health problem and an established risk factor for cardiovascular diseases. Bariatric surgery profoundly reduces body weight and mitigates sequelae of obesity. Especially randomized trials comparing the effects of bariatric surgery to conservative treatment in concerns of cardiac function are still lacking.

The randomized WAS trial compares the effects of Roux-en-Y gastric bypass (RYGB) versus psychotherapy-supported lifestyle modification in morbidly obese patients. The co-primary endpoint addresses 1-year changes in cardiovascular function (peak VO2 during cardiopulmonary exercise testing) and quality of life (Short-Form-36 physical functioning scale). Prior to randomization, all included patients underwent a multimodal anti-obesity treatment for 6-12 months. Thereafter, patients were randomized and followed through month 12 to collect primary endpoints. Afterwards, patients in the lifestyle group could opt for surgery, and final visit was scheduled for all patients 24 months after randomization.

The study was initially designed in 2008 as part of several interdisciplinary studies for a targeted grant and received a positive vote from the responsible ethics committee.

Prior the actual start of the study in July 2011, the initial study protocol and the patient informed consent were updated and further specified. This amendment was submitted to the Ethics Committee on June 9, 2011, with a positive vote on June 30, 2011 (Amendment 1).

An Amendment 2 was submitted to Ethics Committee on 08.10.2014 (positive vote 16.12.2014) to adjust randomization (previously 1:1 to the two study arms) for an unequal drop-out rate in the two study arms with higher rate in the intensified lifestyle modification. In addition, few secondary endpoints were adapted and the role of the principal investigator changed from Prof. Stefan Frantz to Prof. Martin Fassnacht.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 28, 2019
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• BMI >40 kg/m2 or BMI >35 kg/m2 with severe comorbidities

• Indication for Roux-en-Y gastric bypass surgery

• Ability to perform cardiopulmonary exercise testing (CPET)

• Written informed consent

Exclusion Criteria:

• Pregnancy or breast feeding

• Unstable angina pectoris

• Life expectancy <12 months

• Endocrine or psychiatric disorder as cause of obesity

• Systemic glucocorticoid treatment (with exception of glucocorticoid replacement therapy)

• Abuse of drugs or alcohol within the last 5 years

• Inability to attend regular study visits for logistic reasons

• Participation in competing trials

Related Conditions & MeSH terms

• Cardiac Function
• Obesity
• Obesity, Morbid
• Quality of Life

Intervention

Procedure:
• Roux-en-Y gastric bypass

Behavioral:
• Psychotherapy-enhanced lifestyle intervention

Locations

Country	Name	City	State
Germany	University hospital, University of Wuerzburg	Wuerzburg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
University of Wuerzburg	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Koschker AC, Warrings B, Morbach C, Seyfried F, Rickert N, Jung P, Geier A, Dischinger U, Krauthausen M, Herrmann MJ, Stier C, Frantz S, Malzahn U, Stork S, Fassnacht M. Cardio-psycho-metabolic outcomes of bariatric surgery: design and baseline of the WAS trial. Endocr Connect. 2022 Feb 9;11(2):e210338. doi: 10.1530/EC-21-0338. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of peak VO2 to assess cardiorespiratory performance	Change of peak V O2 (measured in ml/min/kg bw) in cardiopulmonary exercise testing (CPET)	12 months after surgery / lifestyle intervention
Primary	Change in physical functioning scale (PFS) of the SF-36 to assess quality of life	Change of quality of life measured with physical functioning scale (PFS) of the SF-36 questionnaire (Short Form health survery 36). The score ranges from 0-100 and higher values correspond to better quality of life.	12 months after surgery / lifestyle intervention
Secondary	Change in health related quality of life (other domains than physical functioning scale)	Change in quality of life (using Short Form (SF-36) health survey 36). The score ranges from 0-100 and higher values correspond to better quality of life.	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in left ventricular mass (index)	Assessment with echocardiography (g and g/m^2 body surface area)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Changes in left atrial dimensions	Assessment with echocardiography (left atrial enddiastolic volume (mm^3), left atrial enddiastolic diameter (mm))	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Changes in left ventricular dimensions	Assessment with echocardiography (left ventricular enddiastolic volume (mm^3), left ventricular enddiastolic diameter (mm))	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in left ventricular systolic function	Assessment with echocardiography (left ventricular ejection fraction (%), longitudinal strain)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in prevalence of left ventricular diastolic dysfunction	Assessment with echocardiography (Defined as reduced LVEF, LV hypertrophy, or LV dilation, as well as if three out of the following four criteria were fulfilled 77: LA dilation, average E/e' >14, lateral e' <0.1 m/s or septal e' <0.07 m/s, tricuspid regurgitation maximal flow velocity >2.8 m/s)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in physical performance	Distance (m) achieved in the 6 minute walk test	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in brain morphology	Structural MRI of the brain to assess change in grey matter volume of the cerebellum (compared to normal weight controls)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in brain activity	Functional MRI of the brain to assess activation to high caloric food stimuli in obese patients in insula and anterior cingulate gyrus (compared to normal weight controls)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in brain oxygenation	Functional near-infrared spectroscopy (fNIRS) with assessment of frontal cortical oxygenation during Verbal Fluency Test and Trail Making Test and assessment of low frequency oscillations in resting state (in comparison to normal weight controls)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in left ventricular function	Cardiac MR imaging with analysis of left ventricular function (left ventricular ejection fraction, %)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in cardiac lipid content	Cardiac MR imaging with spectroscopy to measure cardiac lipid content (% fat content)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in depressed mood	Assessment of depressed mood using Patient Health Questionnaire 9 (PHQ-9). The score ranges from 0-27, higher values correspond to more pronounced depressive symptoms.	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in depression	Assessment of depressed mood using Beck's Depression Inventory (BDI-II). The score ranges from 0-63, higher values correspond to more pronounced depressive symptoms.	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in liver stiffness	Assessment of liver stiffness using transient elastography (kPa)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in liver triglyceride content	Assessment of liver triglyceride content with MR spectroscopy (% liver fat)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in burden of comorbidities (type 2 diabetes mellitus)	Assessment of type 2 diabetes by predefined criteria. If the patient fulfils one of the following criteria, he/she would count as diabetic patient: fasting blood sugar level >= 126mg/dl, A1c => 6.5%, glucose of >=200 mg/dl 2hours in oral glucose tolerance test, or use of at least one antidiabetic medication.	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in burden of comorbidities (arterial hypertension)	Assessment of arterial hypertension according to predefined criteria. If the patient fulfils one of the following criteria, he/she would count as antihypertensive: systolic blood pressure >= 140mmHg, diastolic blood pressure >= 90mmHg, or use of at least one antihypertensive drug.	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in burden of comorbidities (dyslipidemia)	Assessment of dyslipidemia according to predefined criteria (depending on values for fasting triglycerides and ldl-cholesterol, lipid lowering medication)	12 and 24 months after bariatric surgery / lifestyle intervention
Secondary	Change in NYHA functional class	Assessment of NYHA functional class (NYHA I-IV, a higher class meaning more dyspnea)	12 and 24 months after bariatric surgery / lifestyle intervention