Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 15, 2024
Date Accepted: Mar 24, 2025
Metabolic flexibility to predict lifestyle interventions outcomes (MEPHISTO) - a protocol for a predictive validation study and randomized controlled trial
ABSTRACT
Background:
Weight loss is a cornerstone of diabetes mellitus type 2 (T2D) management, but its implementation in clinical practice is limited by its perceived burden and variability in response. Personalising interventions to increase their success rate is an unmet clinical need.
Objective:
Identification of predictive factors associated with successful weight loss after sequential exercise in women with obesity.
Methods:
The study will consist of a two-stage analytical approach including a predictive validation study and a 2:1 randomised cross-over controlled trial. Participants Women aged 25-45 years with obesity (BMI>30) will be included in the study. Intervention The intervention will consist of a progressive protocol of aerobic exercise on a treadmill and a bicycle ergometer. Outcomes FM/FFM weight loss, metabolic flexibility via ΔRQ (change in respiratory quotient (VCO2/VO2) between basal and insulin-stimulated state during glucose clamp), insulin sensitivity, glucose tolerance, HbA1c, microbiome composition, metabolomic signatures will be measured.
Results:
Recruitment for the trial began in January 2024. 12 participants were enrolled and randomised. Six participants have completed the first phase of the A-arm and 6 participants have completed the control period of the B-arm and their intervention is ongoing. Recruitment is ongoing. We expect the preliminary data from this study to be completed in 2026.
Conclusions:
This intervention will investigate whether whole body and gut MetFlex can be further explored and used as ex-ante predictors of successful weight loss following exercise and dietary interventions, providing proof of concept and paving the way for personalised lifestyle interventions. Clinical Trial: NCT06329349
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