Sarcopenic Obesity in the Elderly

NCT06083909 | Completed

• 1 other identifier: STUDY00003268
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenic Obesity; Diabetes

Outcome Measures

Primary Outcomes (1)

• To explore the correlation of sarcopenia and obesity on insulin resistance

  2 years

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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 We estimate that less than 10% of the consented participants will not meet the inclusionary criteria and will be withdrawn. As this study involves a solitary study visit, we estimate that less than 5% of the participants will withdraw/be withdrawn/ or be lost to follow up prior to study completion.

You may qualify if:

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

You may not qualify if:

• Lack capacity to consent for the study, or have moderate or severe cognitive impairment;
• Have difficulty ambulating as evidenced by any one of the following:
• Difficulty climbing 10 steps without resting;
• Restricted to a wheelchair
• Have difficulty performing basic activities of daily living;
• Have had treatment for cancer in the prior 3 years;
• Have history of cachexia;
• Have a history of heart failure;
• Have a permanent pacemaker in situ (due to magnetic resonance scanning);
• Have an implanted cardioverter-defibrillator (ICD) in situ;
• Have had myocardial infarction within the last 6 months;
• Have any of the following chronic health conditions: peripheral arterial disease prostate cancer, rheumatoid arthritis, autoimmune myositis, chronic obstructive pulmonary disease, and asthma;
• Are receiving therapy with corticosteroids or immunosuppressants.
• Are taking direct insulin sensitizers (PPAR-gamma agonists, or thiazolidinediones).

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: April 6, 2022
• Primary Completion: April 19, 2023
• Study Completion: May 8, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

US (1)