Association Between Peripheral Muscle Function and Quality of Life in Obese Subjects

NCT05467020 | Completed DMC

• 1 other identifier: 2021-A03248-33
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The assessment of health status and physical function is fundamental in patients with obesity, as they play an important role among the various factors influencing the quality of life in this population. Several studies have shown an association between high BMI values and a significant deterioration in quality of life, especially in women. Excess body fat in obese patients seems to be responsible for muscle atrophy. This causal link is probably related to dysfunctions in adipose tissue, leading to a decrease in the expression of proteins responsible for muscle contraction. The recent literature highlights an alteration in quality of life, particularly in obese and elderly subjects, for which changes in muscle function are partly responsible. Changes in muscle function can be assessed by simple, rapid and non-invasive tools. They could be used to identify obese subjects at risk of they could be used to identify obese subjects at risk of muscle atrophy, to stratify the risk, and to propose prophylactic intervention or early management. The main objective of this study is to evaluate the association between structural alteration of the quadriceps and quality of life in obese patients. The secondary objectives are to evaluate :

• The association between quadriceps thickness and quality of life ;
• The association between grip strength and quality of life ;
• The association between quadriceps strength and quality of life ;
• The association between quadriceps strength and ultrasound measurements of the quadriceps. This is a prospective, monocenter, observationnal and cohort study. All outpatients for nutrition assessment will be included.

Conditions

Obesity

Keywords

obesity; muscle assessment; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Association between structural alteration of the quadriceps and quality of life in obese patients

  The main outcome is the association between rectus femoris muscle echogenicity in the gray scale and the 36-Item Short Form Survey (SF-36) score

  Through study completion, an average of 9 months

Secondary Outcomes (4)

• The association between quadriceps thickness and quality of life

  Through study completion, an average of 9 months

• Association between grip strength and quality of life

  Through study completion, an average of 9 months

• Association between quadriceps strength and quality of life

  Through study completion, an average of 9 months

• Association between quadriceps strength and ultrasound measurements of the quadriceps

  Through study completion, an average of 9 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatients assessment nutrition will be recruited prospectively and consecutively

You may qualify if:

• Patients with the following criteria will be included:
• Outpatients assessment Nutrition ;
• Obese patients (BMI \> 30);
• Affiliation with a social security scheme or beneficiary of such a scheme ;
• Oral, free, informed and express consent of the patient.

You may not qualify if:

• Patient's refusal to participate in the study ;
• Known pregnancy ;
• Patient whose state of consciousness is not compatible with obtaining consent ;
• Person subject to a legal protection measure ;
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (1)

Hôpital Forcilles

Férolles-Attilly, 77150, France

Location

Related Publications (3)

• Toselli S, Campa F, Spiga F, Grigoletto A, Simonelli I, Gualdi-Russo E. The association between body composition and quality of life among elderly Italians. Endocrine. 2020 May;68(2):279-286. doi: 10.1007/s12020-019-02174-7. Epub 2019 Dec 31.

  PMID: 31893349 BACKGROUND

• Tamura LS, Cazzo E, Chaim EA, Piedade SR. Influence of morbid obesity on physical capacity, knee-related symptoms and overall quality of life: A cross-sectional study. Rev Assoc Med Bras (1992). 2017 Feb;63(2):142-147. doi: 10.1590/1806-9282.63.02.142.

  PMID: 28355375 BACKGROUND

• Kim SR, Kim HN, Song SW. Associations Between Mental Health, Quality of Life, and Obesity/Metabolic Risk Phenotypes. Metab Syndr Relat Disord. 2020 Sep;18(7):347-352. doi: 10.1089/met.2020.0028. Epub 2020 May 19.

  PMID: 32429802 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie VIDAL-JESSEL, MD

  Hopital Forcilles

  STUDY DIRECTOR

• Andreia GOMES LOPES, MSc

  Hopital Forcilles

  PRINCIPAL INVESTIGATOR

• Aymeric Le Neindre, PhD

  Hopital Forcilles

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 20, 2022
• Study Start: April 22, 2022
• Primary Completion: July 22, 2023
• Study Completion: October 2, 2023
• Last Updated: October 11, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At publication for 10 years
• Access Criteria: The data that support the findings of this study will be available from the corresponding author upon reasonable request.

Locations

FR (1)