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Randomized Controlled Trial
. 2023 Oct:147:155655.
doi: 10.1016/j.metabol.2023.155655. Epub 2023 Jun 30.

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

Ann-Cathrin Koschker  1 , Bodo Warrings  2 , Caroline Morbach  3 , Florian Seyfried  4 , Pius Jung  5 , Ulrich Dischinger  6 , Frank Edelmann  7 , Martin J Herrmann  2 , Christine Stier  8 , Stefan Frantz  3 , Uwe Malzahn  9 , Stefan Störk  3 , Martin Fassnacht  10 ; WAS study group
Affiliations
Free article
Randomized Controlled Trial

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

Ann-Cathrin Koschker et al. Metabolism. 2023 Oct.
Free article

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.

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Conflict of interest statement

Declaration of competing interest SF, SS, MF have received funding from the German Federal Ministry for Education and Research for the presented study (Grants #01E01004, #01E01504). ACK has received a grant from Bayern Innovativ (MED-1811-0027), consulting fees from Daiichi-Sankyo, and payment for presentations from AstraZeneca, Sanofi, Novartis, NovoNordisk, Amarin, Amgen. CM has received consulting fees from Boehringer Ingelheim and lecture fees from Amgen, TOMTEC Imaging Systems GmbH, Alnylam, AKCEA, Sobi, Alexion, Janssen, Pfizer. UD has received grants from NovoNordisk and the IZKF Würzburg, honoraria for lectures from Alnylam, and participated on the Recordati Rare Diseases Advisory Board. SF has received a grant from the DFG, fees for lectures and support for attending meetings and/or travel from Abbott, Abiomed, Amarin, Amgen, AstraZeneca, Bayer, Berlin-Chemie, Biotronik, Boehringer, Bristol-Myers Squibb, Daiichi-Sankyo, Edwards, Lilly, Novartis, Pfizer, Sanofi-Aventis, Siemens, Vifor, Zoll, participated on an advisory board of Boehringer and the guideline committee of the German Cardiac Society and the German Society of Internal Medicine. The other authors declare that no conflicts of interest exist.

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