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Life sciences · Observational Study
ClinicalTrials.gov · November 2, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07908940). This is a study registration, not published results. Lead sponsor: Hospital San Carlos, Madrid. Recruitment status: ENROLLING_BY_INVITATION. Study type: OBSERVATIONAL. Enrollment: 116 participants (ESTIMATED). Conditions: Obesity (BMI Equal to or >30), Weight Regain After Bariatric Surgery. Primary outcome measures: Sarcopenia , From enrollment to the end of treatment at 6 and 12 months; Percentage of total weight loss (TWL) , From enrollment to the end of treatment at 6 and 12 months. Brief summary: Background: Intentional weight loss via various treatments results in a loss of lean mass of approximately 10% for every 10 kg of total weight lost. There is a paucity of data regarding changes in skeletal muscle mass associated with the novel anti-obesity drugs becoming available-specifically concerning not only quantitative changes but also the potential impact on muscle strength and the ability to perform activities of daily living. Objectives: 1) To determine changes in body composition in individuals with obesity treated with semaglutide or tirzepatide for a period exceeding 6 months. 2) To analyze the impact of these changes on muscle strength and function. Methodology: A prospective, multicenter study coordinated by the Obesity Section of the Spanish Society of Endocrinology and Nutrition (SEEN). The study includes individuals with obesity (without diabetes) undergoing pharmacological treatment with semaglutide or tirzepatide. Body composition is analyzed via bioimpedance before and after treatment. Muscle strength is assessed using handgrip dynamometry and the chair-stand test. Exploratory analyses cover weight loss percentage, weight loss categories, changes in fat mass and fat-free mass (kg and %), and estimates of total and appendicular skeletal muscle mass. Optional sub-studies include abdominal ultrasound (to measure subcutaneous and preperitoneal adipose tissue thickness) and ultrasound of the rectus femoris muscle. Data on side effects, diet, exercise, and quality of life are also recorded. Planned analyses include weight loss percentages, changes in variables following pharmacological treatment, adjustments for confounding variables (age, sex, protein intake, structured physical activity, etc.), and exploratory uni- and multivariate logistic regression analyses.