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ObesityWASNCT01352403

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

A study testing Roux-en-Y gastric bypass and Psychotherapy-enhanced lifestyle intervention in people with Obesity and Cardiac Function, run by University of Wuerzburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Cardiac Function, Quality of Life
What is being tested?
Roux-en-Y gastric bypass and Psychotherapy-enhanced lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteGermany
Study dates
4 Jul 2011to 28 Jan 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University hospital, University of Wuerzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

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

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.

Read the detailed 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.

Being tested
Roux-en-Y gastric bypass, Psychotherapy-enhanced lifestyle intervention
Keywords
obesity, bariatric surgery, gastric bypass, life style intervention, cardiac function
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roux-en-Y gastric bypassProcedure or surgery

  • Psychotherapy-enhanced lifestyle interventionBehavioural

Study groups in NCT01352403
Study groupRoleWhat they receive
Psychotherapy-enhanced lifestyle intervention (PELI)OtherIntensive lifestyle intervention over 12 months including medically supervised dietary counseling and physical activity enhanced by a psychotherapeutic intervention
Receives: Behavioral: Psychotherapy-enhanced lifestyle intervention
Roux-en-Y-gastric bypass (RYGB)OtherLaparoscopic Roux-en-Y gastric bypass surgery
Receives: Procedure: Roux-en-Y gastric bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of peak VO2 to assess cardiorespiratory performance

    Change of peak V O2 (measured in ml/min/kg bw) in cardiopulmonary exercise testing (CPET)

    Measured: 12 months after surgery / lifestyle intervention

  2. 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.

    Measured: 12 months after surgery / lifestyle intervention

Secondary outcomes (20)

  1. 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.

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  2. Change in left ventricular mass (index)

    Assessment with echocardiography (g and g/m^2 body surface area)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  3. Changes in left atrial dimensions

    Assessment with echocardiography (left atrial enddiastolic volume (mm^3), left atrial enddiastolic diameter (mm))

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  4. Changes in left ventricular dimensions

    Assessment with echocardiography (left ventricular enddiastolic volume (mm^3), left ventricular enddiastolic diameter (mm))

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  5. Change in left ventricular systolic function

    Assessment with echocardiography (left ventricular ejection fraction (%), longitudinal strain)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  6. 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)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  7. Change in physical performance

    Distance (m) achieved in the 6 minute walk test

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  8. Change in brain morphology

    Structural MRI of the brain to assess change in grey matter volume of the cerebellum (compared to normal weight controls)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  9. 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)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  10. 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)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  11. Change in left ventricular function

    Cardiac MR imaging with analysis of left ventricular function (left ventricular ejection fraction, %)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  12. Change in cardiac lipid content

    Cardiac MR imaging with spectroscopy to measure cardiac lipid content (% fat content)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  13. 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.

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  14. 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.

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  15. Change in liver stiffness

    Assessment of liver stiffness using transient elastography (kPa)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  16. Change in liver triglyceride content

    Assessment of liver triglyceride content with MR spectroscopy (% liver fat)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  17. 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.

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  18. 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.

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  19. 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)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

  20. Change in NYHA functional class

    Assessment of NYHA functional class (NYHA I-IV, a higher class meaning more dyspnea)

    Measured: 12 and 24 months after bariatric surgery / lifestyle intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2011 (estimated)
  2. Study start4 Jul 2011
  3. Primary completion10 Sep 2018
  4. Study completion28 Jan 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01352403
Sponsor's protocol ID
2008-005054-20
Other IDs
2008
Acronym
WAS
Status last verified
Feb 2023
First submitted
10 May 2011
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35015697

Questions about this trial

What is this clinical trial studying?

A study testing Roux-en-Y gastric bypass and Psychotherapy-enhanced lifestyle intervention in people with Obesity and Cardiac Function, run by University of Wuerzburg at 1 site in Germany.

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 8 Feb 2023. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of peak VO2 to assess cardiorespiratory performance (time frame: 12 months after surgery / lifestyle intervention). The study lists 2 primary outcomes in all. 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 NCT01352403, which also lists 1 linked publication.

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 8 Feb 2023.

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