NCT01352403

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 4, 2011

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

7.2 years

First QC Date

May 10, 2011

Last Update Submit

February 4, 2023

Conditions

ObesityCardiac FunctionQuality of Life

Keywords

obesitybariatric surgerygastric bypasslife style interventioncardiac function

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (20)

  • Change in health related quality of life (other domains than physical functioning scale)

    12 and 24 months after bariatric surgery / lifestyle intervention

  • Change in left ventricular mass (index)

    12 and 24 months after bariatric surgery / lifestyle intervention

  • Changes in left atrial dimensions

    12 and 24 months after bariatric surgery / lifestyle intervention

  • Changes in left ventricular dimensions

    12 and 24 months after bariatric surgery / lifestyle intervention

  • Change in left ventricular systolic function

    12 and 24 months after bariatric surgery / lifestyle intervention

  • +15 more secondary outcomes

Study Arms (2)

Psychotherapy-enhanced lifestyle intervention (PELI)

OTHER

Intensive lifestyle intervention over 12 months including medically supervised dietary counseling and physical activity enhanced by a psychotherapeutic intervention

Behavioral: Psychotherapy-enhanced lifestyle intervention

Roux-en-Y-gastric bypass (RYGB)

OTHER

Laparoscopic Roux-en-Y gastric bypass surgery

Procedure: Roux-en-Y gastric bypass

Interventions

Roux-en-Y gastric bypassPROCEDURE
Roux-en-Y-gastric bypass (RYGB)
Psychotherapy-enhanced lifestyle interventionBEHAVIORAL
Psychotherapy-enhanced lifestyle intervention (PELI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital, University of Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

Related 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.

    PMID: 35015697BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Department of Endocrinology and Diabetology

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 11, 2011

Study Start

July 4, 2011

Primary Completion

September 10, 2018

Study Completion

January 28, 2019

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

DE(1)