Sarcopenic Obesity in the Elderly

Diabetes Clinical Trial

Official title:

Sarcopenic Obesity as Risk Factor for Insulin Resistance in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06083909
• Other study ID #: STUDY00003268
• Status: Completed
• Start date: April 6, 2022
• Est. completion date: May 8, 2023

Study information

• Verified date: October 2023
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 8, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Sarcopenic Obesity

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore the correlation of sarcopenia and obesity on insulin resistance		2 years
Secondary	To explore the correlation between muscle strength and memory loss		2 years
Secondary	To explore the correlation of sarcopenic obesity and glucometabolic and cardiovascular risk.		2 years