Assessment of Body Composition and Physical Function

NCT05784571 | Completed Results

• 1 other identifier: PBRC 2023-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Composition; Physical Function

Outcome Measures

Primary Outcomes (3)

• Fat Mass

  Measurement of fat mass

  One day

• Fat-free Mass

  Measurement of fat-free mass

  One day

• Modified Physical Performance Test

  Test for assessing physical performance. The scale ranges from 0 to 36 and higher score indicates a better outcome

  One day

Secondary Outcomes (3)

• Hand Grip Strength

  One day

• 6-minute Walk Test

  One day

• Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  One day

Study Arms (1)

Older Adults

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

Other: Body Composition Assessment; Other: Modified Physical Performance Test; Other: Hand grip strength; Other: 6-minute walk test; Procedure: Measurement of blood glucose and insulin

Interventions

Body Composition Assessment OTHER

Assessment of body composition using bioelectrical impedance analysis.

Older Adults

Modified Physical Performance Test OTHER

A test of physical functioning

Older Adults

Hand grip strength OTHER

A test of hand grip strength using a hand dynamometer.

Older Adults

6-minute walk test OTHER

Self-paced test of walking capacity.

Older Adults

Measurement of blood glucose and insulin PROCEDURE

Blood will be drawn for measurement of glucose and insulin.

Older Adults

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 60 - 80 years with obesity.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

• 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.

  PMID: 24131857 BACKGROUND

• 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.

  PMID: 25794879 BACKGROUND

MeSH Terms

Interventions

Hand Strength; Insulin

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Candida Rebello
• Organization: Pennington Biomedical Research Center, Baton Rouge, LA

Candida.Rebello@pbrc.edu

2257633159

Study Officials

• Candida J Rebello, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 27, 2023
• Study Start: March 13, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 30, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)