Effect of bariatric surgery on cardio-psycho-metabolic outcomes in severe obesity: A randomized controlled trial

Ann-Cathrin Koschker; Bodo Warrings; Caroline Morbach; Florian Seyfried; Pius Jung; Ulrich Dischinger; Frank Edelmann; Martin J Herrmann; Christine Stier; Stefan Frantz; Uwe Malzahn; Stefan Störk; Martin Fassnacht; WAS study group

doi:10.1016/j.metabol.2023.155655

Effect of bariatric surgery on cardio-psycho-metabolic outcomes in severe obesity: A randomized controlled trial

Metabolism. 2023 Oct:147:155655. doi: 10.1016/j.metabol.2023.155655. Epub 2023 Jun 30.

Authors

Affiliations

¹ Dept. Internal Medicine I, Division of Endocrinology and Diabetology, University Hospital, University of Würzburg, Würzburg, Germany; Dept. Clinical Research & Epidemiology, Comprehensive Heart Failure Center, University Hospital, University of Würzburg, Würzburg, Germany. Electronic address: koschker_a@ukw.de.
² Dept. Clinical Research & Epidemiology, Comprehensive Heart Failure Center, University Hospital, University of Würzburg, Würzburg, Germany; Dept. Psychiatry, Psychosomatics, and Psychotherapy, Center for Mental Health, University Hospital, University of Würzburg, Würzburg, Germany.
³ Dept. Clinical Research & Epidemiology, Comprehensive Heart Failure Center, University Hospital, University of Würzburg, Würzburg, Germany; Dept. of Internal Medicine I, Division of Cardiology, University Hospital, University of Würzburg, Würzburg, Germany.
⁴ Dept. General, Visceral, Transplant, Vascular, and Pediatric Surgery, University Hospital, University of Würzburg, Würzburg, Germany.
⁵ Dept. Internal Medicine I, Division of Pneumology, University Hospital, University of Würzburg, Würzburg, Germany.
⁶ Dept. Internal Medicine I, Division of Endocrinology and Diabetology, University Hospital, University of Würzburg, Würzburg, Germany.
⁷ Dept. Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin, Berlin, Germany; German Centre for Cardiovascular research (DZHK), Partner Site Berlin, Germany.
⁸ Dept. Internal Medicine I, Division of Endocrinology and Diabetology, University Hospital, University of Würzburg, Würzburg, Germany; Dept. General, Visceral, Transplant, Vascular, and Pediatric Surgery, University Hospital, University of Würzburg, Würzburg, Germany.
⁹ Center for Clinical Trials, University Hospital Würzburg, Würzburg, Germany.
¹⁰ Dept. Internal Medicine I, Division of Endocrinology and Diabetology, University Hospital, University of Würzburg, Würzburg, Germany; Dept. Clinical Research & Epidemiology, Comprehensive Heart Failure Center, University Hospital, University of Würzburg, Würzburg, Germany.

PMID: 37393945
DOI: 10.1016/j.metabol.2023.155655

Abstract

Objective: Randomized evidence comparing the cardiovascular effects of surgical and conservative weight management is lacking.

Patients & methods: In this single-center, open-label randomized trial, obese patients with indication for Roux-en-Y gastric bypass (RYGB) and able to perform treadmill cardiopulmonary exercise testing (CPET) were included. After a 6-12 month run-in phase of multimodal anti-obesity treatment, patients were randomized to RYGB or psychotherapy-enhanced lifestyle intervention (PELI) and co-primary endpoints were assessed 12 months later. Thereafter, PELI patients could opt for surgery and patients were reassessed 24 months after randomization. Co-primary endpoints were mean change (95 % confidence intervals) in peak VO₂ (ml/min/kg body weight) in CPET and the physical functioning scale (PFS) of the Short Form health survey (SF-36).

Results: Of 93 patients entering the study, 60 were randomized. Among these (median age 38 years; 88 % women; mean BMI 48·2 kg/m²), 46 (RYGB: 22 and PELI: 24) were evaluated after 12 months. Total weight loss was 34·3 % after RYGB vs. 1·2 % with PELI, while peak VO₂ increased by +4·3 ml/min/kg (2·7, 5·9) vs +1·1 ml/min/kg (-0·2, 2·3); p < 0·0001. Respective improvement in PFS score was +40 (30, 49) vs +10 (1, 15); p < 0·0001. 6-minute walking distance also favored the RYGB group: +44 m (17, 72) vs +6 m (-14, 26); p < 0·0001. Left ventricular mass decreased after RYGB, but not with PELI: -32 g (-46, -17) vs 0 g (-13,13); p < 0·0001. In the non-randomized follow-up, 34 patients were assessed. Favorable changes were sustained in the RYGB group and were repeated in the 15 evaluated patients that opted for surgery after PELI.

Conclusions: Among adults with severe obesity, RYGB in comparison to PELI resulted in improved cardiopulmonary capacity and quality of life. The observed effect sizes suggest that these changes are clinically relevant.

Keywords: Cardiopulmonary exercise testing; Lifestyle intervention; Morbid obesity; Quality of life; Roux-en-Y gastric bypass.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Bariatric Surgery*
Female
Gastric Bypass*
Humans
Life Style
Male
Obesity / complications
Obesity / surgery
Obesity, Morbid* / surgery
Quality of Life
Retrospective Studies
Treatment Outcome