Ludlova Monika, Koudelková Kateřina, Pallova Jitka, Koudelkova Barbora, Siklova Michaela, Cahova Monika, Vetrovsky Tomas, Steffl Michal, Gojda Jan
Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.
Clinical Research Department, Kralovske Vinohrady University Hospital and Third Faculty of Medicine, Charles University, Prague, Czech Republic.
JMIR Res Protoc. 2025 May 8;14:e67570. doi: 10.2196/67570.
Weight loss is a cornerstone of obesity treatment and diabetes mellitus type 2 (T2D) prevention, but its implementation in clinical practice is limited by its perceived burden and variability in response. Personalizing interventions to increase their success rate is an unmet clinical need.
Identification of predictive factors associated with successful weight loss after sequential exercise in women with obesity.
The study will consist of a 2-stage analytical approach, including a predictive validation study and a 2:1 randomized cross-over controlled trial. Women aged 25-45 years with obesity (BMI>30) will be included in the study. The intervention will consist of a progressive protocol of aerobic exercise on a treadmill and a bicycle ergometer. We will measure weight loss in terms of fat mass (FM) and fat-free mass (FFM), metabolic flexibility (MetFlex) as ΔRQ (change in respiratory quotient (VCO2/VO2) between basal and insulin-stimulated state during glucose clamp), insulin sensitivity, glucose tolerance, hemoglobin A, microbiome composition, and metabolomic signatures.
Recruitment for the trial began in January 2024. A total of 12 participants were enrolled and randomized. Among them 6 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.
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 intervention, providing proof of concept and paving the way for personalized lifestyle interventions.
ClinicalTrials.gov NCT06329349; https://clinicaltrials.gov/study/NCT06329349.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67570.
体重减轻是肥胖症治疗和2型糖尿病（T2D）预防的基石，但其在临床实践中的应用受到其感知负担和反应变异性的限制。个性化干预措施以提高其成功率是一项未满足的临床需求。
确定肥胖女性连续运动后成功减重的预测因素。
该研究将采用两阶段分析方法，包括预测性验证研究和2:1随机交叉对照试验。纳入年龄在25 - 45岁、患有肥胖症（BMI>30）的女性。干预措施将包括在跑步机和自行车测力计上进行的有氧运动渐进方案。我们将从脂肪量（FM）和去脂体重（FFM）、代谢灵活性（MetFlex）（以葡萄糖钳夹期间基础状态和胰岛素刺激状态之间的呼吸商变化（ΔRQ，即VCO2/VO2）衡量）、胰岛素敏感性、葡萄糖耐量、糖化血红蛋白、微生物群组成和代谢组学特征等方面测量体重减轻情况。
该试验于2024年1月开始招募。共招募了12名参与者并进行了随机分组。其中6名参与者完成了A组的第一阶段，6名参与者完成了B组的对照期，其干预仍在进行中。招募工作正在进行。我们预计这项研究的初步数据将于2026年完成。
这项干预措施将研究全身和肠道MetFlex是否可以进一步探索并用作运动干预后成功减重的事前预测指标，提供概念验证并为个性化生活方式干预铺平道路。
ClinicalTrials.gov NCT06329349；https://clinicaltrials.gov/study/NCT06329349。
国际注册报告识别码（IRRID）：DERR1-10.2196/67570。
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