Sarcopenic Obesity in the Elderly

Sarcopenic Obesity as Risk Factor for Insulin Resistance in the Elderly

Ageing is associated with progressive and generalized loss of muscle mass and muscle function, also known as Sarcopenia. Increasingly, obesity has become a compounding factor in ageing-related sarcopenia. The coexistence of obesity and sarcopenia is termed sarcopenic obesity (SO). Older adults with SO are at higher risks of developing diabetes, hypertension, stroke, cardiovascular diseases, and cognitive dysfunction than those older adults who suffer from sarcopenia alone or obesity alone. However, there is insufficient information with regard to the interplay between obesity and sarcopenia. The primary objective of this study is to investigate the impact of SO on insulin resistance in people aged 65-85. Our hypothesis is that SO positively influences insulin resistance in the elderly. We propose to investigate sarcopenia and obesity as risk factors for insulin resistance in the geriatric (65-85 years old) population.

Study Overview

• Status: Completed
• Conditions: Diabetes; Sarcopenic Obesity

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will include both men and women who are aged 65-85. We plan to recruit a minimum of 25 men and 25 women but no more than 60 of each gender. The maximum sample size is 100. We estimate that less than 10% of the consented participants will not meet the inclusionary criteria and will be withdrawn. As this study involves a solitary study visit, we estimate that less than 5% of the participants will withdraw/be withdrawn/ or be lost to follow up prior to study completion.

Description

Inclusion Criteria:

This study will include both male and females aged 65-85 years.

Exclusion Criteria:

1. Lack capacity to consent for the study, or have moderate or severe cognitive impairment;

2. Have difficulty ambulating as evidenced by any one of the following:

   1. Difficulty climbing 10 steps without resting;
   2. Restricted to a wheelchair
3. Have difficulty performing basic activities of daily living;
4. Have had treatment for cancer in the prior 3 years;
5. Have history of cachexia;
6. Have a history of heart failure;
7. Have a permanent pacemaker in situ (due to magnetic resonance scanning);
8. Have an implanted cardioverter-defibrillator (ICD) in situ;
9. Have had myocardial infarction within the last 6 months;
10. Have any of the following chronic health conditions: peripheral arterial disease prostate cancer, rheumatoid arthritis, autoimmune myositis, chronic obstructive pulmonary disease, and asthma;
11. Are receiving therapy with corticosteroids or immunosuppressants.
12. Are taking direct insulin sensitizers (PPAR-gamma agonists, or thiazolidinediones).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To explore the correlation of sarcopenia and obesity on insulin resistance	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To explore the correlation between muscle strength and memory loss	2 years
To explore the correlation of sarcopenic obesity and glucometabolic and cardiovascular risk.	2 years

Collaborators and Investigators

• Sponsor: University of Central Florida
• Investigators: Principal Investigator: Muthu Periasamy, PhD, University of Central Florida; Principal Investigator: Mariana Dangiolo, MD, University of Central Florida; Principal Investigator: Ali Rizvi, MD, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): May 8, 2023

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: STUDY00003268

Drug and device information, study documents

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