Clinical trial NCT05784571: Assessment of Body Composition and Physical Function
Official title: Assessment of Body Composition and Physical Function in Older Adults With Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Composition
Physical Function
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 60 - 80 years with obesity.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fat Mass
timeFrame: One day
measure: Fat-free Mass
timeFrame: One day
measure: Modified Physical Performance Test
timeFrame: One day
Secondary outcomes:
measure: Hand Grip Strength
timeFrame: One day
measure: 6-minute Walk Test
timeFrame: One day
measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: One day
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Candida J Rebello, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.