Assessment of Body Composition and Physical Function

NCT ID: NCT05784571

Last Updated: 2024-07-30

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-13

Study Completion Date

2023-06-01

Brief Summary

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Sarcopenia, which is the loss of muscle mass and strength or physical function, naturally occurs in aging. In sarcopenic obesity, growth of muscle mass and increments in strength do not parallel weight gain, and places older adults at increased risk of falls, fractures, physical disability, frailty, and mortality from too low muscle strength relative to body size. The goal of the study is to assess body composition and physical function in older adults with obesity.

Detailed Description

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This is a cross-sectional study in 40 adults aged 60 to 80 years with obesity. Body composition, physical function, and insulin resistance will be measured. Subjects who satisfy the eligibility criteria and sign the informed consent will be enrolled. Subjects will complete an assessment of body composition by bioelectrical impedance analysis and tests of physical performance. Blood will be drawn for measurement of fasting glucose and insulin.

Conditions

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Body Composition Physical Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Older Adults

Adults 60-80 years of age with body mass index \> 30kg/m2

Body Composition Assessment

Intervention Type OTHER

Assessment of body composition using bioelectrical impedance analysis.

Modified Physical Performance Test

Intervention Type OTHER

A test of physical functioning

Hand grip strength

Intervention Type OTHER

A test of hand grip strength using a hand dynamometer.

6-minute walk test

Intervention Type OTHER

Self-paced test of walking capacity.

Measurement of blood glucose and insulin

Intervention Type PROCEDURE

Blood will be drawn for measurement of glucose and insulin.

Interventions

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Body Composition Assessment

Assessment of body composition using bioelectrical impedance analysis.

Intervention Type OTHER

Modified Physical Performance Test

A test of physical functioning

Intervention Type OTHER

Hand grip strength

A test of hand grip strength using a hand dynamometer.

Intervention Type OTHER

6-minute walk test

Self-paced test of walking capacity.

Intervention Type OTHER

Measurement of blood glucose and insulin

Blood will be drawn for measurement of glucose and insulin.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Body mass index \> 30kg/m2
* Age 60 - 80 years

Exclusion Criteria

* self-reported history of diabetes, or cancer or significant cardiovascular or hepatic or renal disease or dysfunction.
* clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac disease.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Candida Rebello

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Candida J Rebello, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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Gayoso-Diz P, Otero-Gonzalez A, Rodriguez-Alvarez MX, Gude F, Garcia F, De Francisco A, Quintela AG. Insulin resistance (HOMA-IR) cut-off values and the metabolic syndrome in a general adult population: effect of gender and age: EPIRCE cross-sectional study. BMC Endocr Disord. 2013 Oct 16;13:47. doi: 10.1186/1472-6823-13-47.

Reference Type BACKGROUND
PMID: 24131857 (View on PubMed)

Ghasemi A, Tohidi M, Derakhshan A, Hasheminia M, Azizi F, Hadaegh F. Cut-off points of homeostasis model assessment of insulin resistance, beta-cell function, and fasting serum insulin to identify future type 2 diabetes: Tehran Lipid and Glucose Study. Acta Diabetol. 2015 Oct;52(5):905-15. doi: 10.1007/s00592-015-0730-3. Epub 2015 Mar 22.

Reference Type BACKGROUND
PMID: 25794879 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PBRC 2023-001

Identifier Type: -

Identifier Source: org_study_id

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