Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P50-P75 for all trials

Timeline

10mo left

Started May 2024

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Progress71%

May 2024Mar 2027

Study Start

First participant enrolled

May 24, 2024

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed

3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

November 7, 2024

Last Update Submit

February 4, 2025

Conditions

Sarcopenic Obesity

Keywords

Sarcopenic obesityobesitynutritiongut microbiomediagnostic ciriteria

Outcome Measures

Primary Outcomes (70)

Association between diagnostic criteria for Sarcopenic Obesity and hemochrome in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and ferritin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and transferrin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and iron in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and AST in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and ALT in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and GGT in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and alkaline phosphatase in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and total bilirubin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and fractionated bilirubin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and triglyceride in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and free fatty acid (FFA) in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and total cholesterol in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and HDL-Cholesterol in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and LDL-Cholesterol in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Apo A1 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Apo B in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and serum creatinine in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and blood urea nitrogen in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and total proteins in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and albumin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and pseudocholinesterase in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and vitamin D3 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Vitamin B12 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Vitamin B6 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Hs-CRP in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Atrial Natriuretic Peptide (ANP) in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Brain Natriuretic Peptide in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and standard OGTT glycaemia in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and standard OGTT insulin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and C-peptide in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and TSH in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and FT3 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and FT4 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and GH in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and IGF-1 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and acylated ghrelin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and unacylated ghrelin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and testosterone (in men) in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and estradiol (in women) in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and adrenal-derived dehydroepiandrosterone in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and myostatin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and leptin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and adiponectin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Irisin in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and parathormone in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and cortisol in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and sodium in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and potassium in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and calcium in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and phosphorus in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and chloride in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and magnesium in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and TNF-α in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 6 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 8 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 10 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 15 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and interleukine 18 in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and hand-grip strength test in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and 5- time sit-to-stand test in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and balance test in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Gait speed 4m in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and 6-minute walk test in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Knee extension strenght in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Sit and reach test in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Time up and go test in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and One-Leg Standing balance in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and 30s chair stand test in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and Joint mobility test in Odd Ratios as assessed by Multivariate analysis
baseline, 6 month

Secondary Outcomes (7)

Association between diagnostic criteria for Sarcopenic Obesity and Energy expenditure in Odd Ratios as assessed by multivariate analysis
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
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
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
baseline, 6 month
Association between diagnostic criteria for Sarcopenic Obesity and appendicular lean mass to weight in Odd Ratios as assessed by multivariate analysis
baseline, 6 month
+2 more secondary outcomes

Other Outcomes (94)

weight in Kilograms
on enrollment day and at the end of the intervention (6 month)
Height in meters
on enrollment day and at the end of the intervention (6 month)
calf circumference in centimeters
on enrollment day and at the end of the intervention (6 month)
+91 more other outcomes

Study Arms (2)

Patient with sarcopenic obesity

Diagnostic Test: DXADiagnostic Test: ultrasonographyDiagnostic Test: indirect calorimetryDiagnostic Test: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)Diagnostic Test: bioimpedentiometry