Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Cohort of Adult Obese Patients and Longitudinal Follow-up

Обзор

Context: Obesity, defined as excessive body fat, can lead to disability and loss of autonomy. If there is concomitant quantitative and qualitative muscle loss, sarcopenic obesity (SO) is suspected in this context. Although this clinical entity was defined several years ago, it is only very recently that precise assessment criteria have been established for screening and diagnosing this pathology (Donini et al. 2022). Defined by the ESPEN/EASO consensus, SO has various consequences for health, particularly in terms of mobility and worsening of co-morbidities. It is therefore necessary to screen for SO, to determine its prevalence in the general population and to identify the determining factors in the loss of muscle mass during obesity. Most studies on the prevalence of sarcopenic obesity focus on the elderly population, bearing in mind that the prevalence of this syndrome in the elderly will increase rapidly as a result of the shift in the incidence of obesity from adults to this population in the coming decades. The aim of this project is to determine the prevalence and determining or predisposing factors for sarcopenic obesity in a population of obese people in a broad age range (18-70 years). Longitudinal follow-up of this cohort is planned in order to assess multifactorial changes (body composition, muscle function and physical performance) at 5 and 10 years after their inclusion in the OBESAR-2 study. In addition, patients who have undergone bariatric surgery will also be followed in the shorter term to analyse the phenotypic changes induced by rapid weight loss on muscle loss.

Вмешательства

• Другое Collection of fluid samples
  \- Blood sampling, urine sampling and tissue sampling

Первичные конечные точки

• To estimate the prevalence of sarcopenia in a population of adult subjects with obesity, at baseline and at 5 and 10 years. [Срок оценки: Day 1 / 5 years /10 years]

Вторичные конечные точки (11)

• % of patients with the factors associated with sarcopenia [Срок оценки: Day 1 / 5 years /10 years]
• concentration of biomarkers in a group of obese patients with sarcopenia using the biobank. [Срок оценки: Day 1 / 5 years /10 years]
• Evaluate the degree of severity of sarcopenic obesity over time using the ESPEN/EASO consensus staging system. [Срок оценки: Day 1 / 5 years /10 years]
• % change of parameters measured to identify the group at risk of accelerated decline [Срок оценки: 5 years /10 years]
• % of evolution of biomarkers [Срок оценки: Day 1 / 5 years /10 years]
• % of risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients. [Срок оценки: Day 1 / 5 years /10 years]
• % of patients with the factors associated with sarcopenia in the subgroup of patients undergoing bariatric surgery. [Срок оценки: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]]
• concentration of biomarkers in a group of obese patients with sarcopenia using the biobank in the subgroup of patients undergoing bariatric surgery. [Срок оценки: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]]
• Evaluate the degree of severity of sarcopenic obesity over time using the ESPEN/EASO consensus staging system in the subgroup of patients undergoing bariatric surgery. [Срок оценки: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]]
• % of evolution of biomarkers in the subgroup of patients undergoing bariatric surgery. [Срок оценки: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
• % of risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients in the subgroup of patients undergoing bariatric surgery. [Срок оценки: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]]

Критерии участия

Критерии включения

• Age: 18-70
• Sex: men and women
• Clinical nutrition patient receiving a metabolic assessment to optimise clinical and paraclinical management
• Patient meeting obesity criteria defined by BMI > 30 kg/m².
• Patient of legal age who has given free, informed and signed consent
• Patient covered by social security

Non-inclusion criteria :

• Patients with cancer or severe chronic disease (renal failure, respiratory failure, liver failure)
• Patients with neuromuscular disease
• Patient with total walking disability
• Patients who are minors
• Patient refusing to take part in the study
• Pregnant or breast-feeding women
• Under guardianship, curatorship, deprived of liberty or under court protection
• Patient who has taken part in the OBESAR study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 1 центр

• CHU Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT06880432 · RBHP 2024 BOIRIE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗