Suspended

SleSOBPrefrailty and Sarcopenic Obesity: Insights through Sleep Disturbances and Biomarkers

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Study Aim

This study aims to observe the prevalence of prefrailty, which includes signs such as reduced muscle mass, fatigue, weakness, slowness, and low physical activity, in individuals with sarcopenic obesity, while also considering sleep disturbances and biomarkers.

What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
No DNA Sample
Who is being recruted

Olfaction Disorders+11

+ Mental Disorders

+ Hyperinsulinism

From 55 to 70 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2017
See protocol details

Summary

Principal SponsorIstituto di Fisiologia Clinica CNR
Study ContactRenata De Maria, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2017

Actual date on which the first participant was enrolled.

This study focuses on understanding the link between sleep disturbances and a condition called sarcopenic obesity, which is a combination of muscle loss and obesity, in young-elderly obese individuals. The study aims to detect prefrailty, an early stage of frailty, which can lead to health issues, loss of independence, and poor quality of life. The goal is to explore how sleep problems might contribute to muscle loss and weakness through changes in glucose metabolism and hormone patterns. The study is particularly interested in obese individuals, as obesity is associated with insulin resistance and increased risk for heart diseases and cognitive decline. Participants in this study will visit the clinic in the morning after fasting. They will undergo various tests, including blood samples for routine and specific biochemistry, measurements of height, weight, and body mass index, and assessments of muscle strength and mass. The study will also evaluate glucose metabolism, sympathetic activation, medical history, cognitive function, sleep patterns, and sense of smell. Participants will wear a device for 24 hours to record heart rate, respiratory rate, oxygen saturation, posture, and physical activity. The main outcome of the study is to determine the prevalence of prefrailty among the participants.

Official TitleSleep Disturbances and Biomarkers of Sarcopenic OBesity: Insight Into Mechanisms of Prefrailty
NCT03175601
Principal SponsorIstituto di Fisiologia Clinica CNR
Study ContactRenata De Maria, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 55 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Olfaction DisordersMental DisordersHyperinsulinismInsulin ResistanceMetabolic DiseasesNervous System DiseasesNeurologic ManifestationsNutritional and Metabolic DiseasesSensation DisordersSigns and SymptomsSleep Wake DisordersPathological Conditions, Signs and SymptomsParasomniasGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate
Obesity : body mass index ≥ 30 and <40 kg/m2

Written informed consent

6 exclusion criteria prevent from participating
Claustrophobia

Active neoplasms

Diabetes requiring insulin treatment

Stage IV chronic kidney dysfunction (estimated glomerular filtration rate <15 ml/min)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Istituto di Fisiologia Clinica del CNR UOS Milano

Milan, ItalyOpen Istituto di Fisiologia Clinica del CNR UOS Milano in Google Maps
SuspendedOne Study Center