Validation of an Algorithm for the Diagnosis of Sarcopenic Obesity

Официальное название

Validation of ESPEN-EASO Algorithm for the Diagnosis of Sarcopenic Obesity (SO)

Обзор

The proposed research project aims to investigate sarcopenic obesity (SO), a condition characterized by the combination of high body fat and low skeletal muscle mass, with a focus on muscle function. SO has been defined according to the ESPEN-EASO algorithm, and this study aims to evaluate its validity, exploring associations with circulating biomarkers and functional outcomes. By enrolling 75 subjects with SO and a control sample of 75 subjects with non-sarcopenic obesity, the primary objective of this study is to examine the consistency of the proposed diagnostic criteria with respect to circulating biomarkers and functional outcomes. Secondary objectives include the assessment of additional variables and the detailed profiling of SO subjects through questionnaires and multidimensional tests. The ethical aspect of the present study will be guaranteed through written informed consent and protection of privacy, respecting international regulatory standards. The investigators believe that this work provides significant contributions to the understanding of sarcopenic obesity and to the validation of diagnostic criteria, with possible implications for public health. The investigators are available for further clarifications and approvals required by the Ethics Committee.

Вмешательства

• Диагностический тест DXA
  Dual energy X-ray absorptiometry
• Диагностический тест ultrasonography
  ultrasonography
• Диагностический тест indirect calorimetry
  indirect calorimetry
• Диагностический тест MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
  MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
• Диагностический тест bioimpedentiometry
  bioimpedentiometry

Первичные конечные точки

• Association between diagnostic criteria for Sarcopenic Obesity and hemochrome in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and ferritin in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and transferrin in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and iron in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and AST in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and ALT in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and GGT in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and alkaline phosphatase in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and total bilirubin in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and fractionated bilirubin in Odd Ratios as assessed by Multivariate analysis [Срок оценки: baseline, 6 month]

Вторичные конечные точки (7)

• Association between diagnostic criteria for Sarcopenic Obesity and Energy expenditure in Odd Ratios as assessed by multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by DXA) in Odd Ratios as assessed by multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and body fat percentage (assessed by BIA) in Odd Ratios as assessed by multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and skeletal muscle mass (assessed by BIA) in Odd Ratios as assessed by multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and appendicular lean mass to weight in Odd Ratios as assessed by multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and bone mineral density in Odd Ratios as assessed by multivariate analysis [Срок оценки: baseline, 6 month]
• Association between diagnostic criteria for Sarcopenic Obesity and visceral adipose tissue (assessed by DXA) in Odd Ratios as assessed by multivariate analysis [Срок оценки: baseline, 6 month]

Критерии участия

Критерии включения

• BMI equal more than 30
• Caucasians

Критерии исключения

• any disease or medication that can significantly affect body composition (eg.malignant diseases in the last 5 years, autoimmune diseases, neurological diseases, syndromic obesity),
• level of physical activity more than 3 METS
• alcohol intake more than 140g/wk for M and 70g/wk for F
• participation in a weight-reducing program (last 3 months),
• impossibility to perform DXA exam
• pregnancy and breast-feeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Италия · 1 центр

• Azienda Policlinico Umberto I — Rome

Идентификаторы

NCT: NCT06815978 · PRIN-202229ET3S

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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