Assessment of Body Composition and Physical Function (Perform)

Assessment of Body Composition and Physical Function in Older Adults With Obesity

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.

Study Overview

• Status: Completed
• Conditions: Body Composition; Physical Function
• Intervention / Treatment: 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

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 60 - 80 years with obesity.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Body Composition Assessment; Assessment of body composition using bioelectrical impedance analysis.; Other: Modified Physical Performance Test; A test of physical functioning; Other: Hand grip strength; A test of hand grip strength using a hand dynamometer.; Other: 6-minute walk test; Self-paced test of walking capacity.; Procedure: Measurement of blood glucose and insulin; Blood will be drawn for measurement of glucose and insulin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Grip Strength	Assessment of grip strength using a hand dynamometer	One day
6-minute Walk Test	Test of walking capacity assessed as distance covered in 6 minutes	One day
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	Assessment of insulin resistance from blood glucose and insulin. HOMA-IR was calculated as: fasting insulin (μU/mL) × fasting glucose (mmol/L)]/22.5 Higher scores indicate greater insulin resistance and a worse outcome. There is no theoretical minimum and/or maximum value for HOMA-IR. Studies have suggested a variety of values that vary based on factors such as gender and age. For example, a large epidemiologic study found that HOMA-IR score of 1.85 in women and 2.17 in men indicated insulin resistance. In another study, the HOMA-IR cut point was found to be 2.37 and 2.38 in 70-year old men and women respectively (see references).	One day

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Candida J Rebello, Ph.D., Pennington Biomedical Research Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: PBRC 2023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No