Sarcopenic Obesity in the Elderly

Sponsor
University of Central Florida (Other)
Overall Status
Completed
CT.gov ID
NCT06083909
Collaborator
(none)
97
1
13
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    97 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Sarcopenic Obesity as Risk Factor for Insulin Resistance in the Elderly
    Actual Study Start Date :
    Apr 6, 2022
    Actual Primary Completion Date :
    Apr 19, 2023
    Actual Study Completion Date :
    May 8, 2023

    Outcome Measures

    Primary Outcome Measures

    1. To explore the correlation of sarcopenia and obesity on insulin resistance [2 years]

    Secondary Outcome Measures

    1. To explore the correlation between muscle strength and memory loss [2 years]

    2. To explore the correlation of sarcopenic obesity and glucometabolic and cardiovascular risk. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    3. Difficulty climbing 10 steps without resting;

    4. Restricted to a wheelchair

    5. Have difficulty performing basic activities of daily living;

    6. Have had treatment for cancer in the prior 3 years;

    7. Have history of cachexia;

    8. Have a history of heart failure;

    9. Have a permanent pacemaker in situ (due to magnetic resonance scanning);

    10. Have an implanted cardioverter-defibrillator (ICD) in situ;

    11. Have had myocardial infarction within the last 6 months;

    12. Have any of the following chronic health conditions: peripheral arterial disease prostate cancer, rheumatoid arthritis, autoimmune myositis, chronic obstructive pulmonary disease, and asthma;

    13. Are receiving therapy with corticosteroids or immunosuppressants.

    14. Are taking direct insulin sensitizers (PPAR-gamma agonists, or thiazolidinediones).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Central Florida Orlando Florida United States 32816

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Central Florida
    ClinicalTrials.gov Identifier:
    NCT06083909
    Other Study ID Numbers:
    • STUDY00003268
    First Posted:
    Oct 16, 2023
    Last Update Posted:
    Oct 19, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2023