Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880108
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-05-25
Brief Title:
Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MARVEL
Brief Summary:
The research in this VA Merit will examine the effects of obesity and Post-COVID Conditions PCC on physical functioning health-related quality of life and adipose tissue inflammatory and cellular senescence profiles in older Veterans Further it will evaluate whether a weight loss intervention including dietary modification and exercise in obese Veterans with and without PCC will reduce systemic and adipose tissue inflammation and senescence and promote PCC recovery
Detailed Description:
Findings of post-acute sequelae of Post-COVID Conditions PCC manifestations of fatigue pain dyspnea and muscle weakness provide a strong rationale for rehabilitation yet few formal studies exist and the effects of severe acute respiratory syndrome coronavirus-2 infection on function are not well described Notably two-thirds of Veterans are overweight and obese rendering excess adiposity a significant risk factor and a high-priority area related to PCC prevention and care Obesity increases the risk of severe illness in Veterans recovering from PCC but how it does so is not fully understood
Recent research suggests that excess adipose tissue is associated with adverse changes in adipose cellular function and that these variations may be involved in the biology of aging and the etiology of aging-related diseases Adipose tissue contains cells that have undergone cellular senescence which induces inflammation cytotoxicity and metabolic dysfunction in other cells and tissues However the precise role of adipose tissue cellular composition on PCC recovery is limited
Thus the investigators propose to evaluate the role of obesity and PCC on physical functioning health-related quality of life HRQOL and systemic and adipose tissue inflammatory and cellular senescence profiles in ethnically diverse older Veterans from the Audie Murphy San Antonio and Baltimore VA Medical Centers Further the investigators propose a randomized controlled trial to determine whether a reduction in body weight and increased physical function by a weight loss intervention WL including dietary modification and exercise in obese Veterans with PCC will reduce systemic and adipose tissue inflammation and senescence which will have important implications for PCC recovery
Recent research suggests that excess adipose tissue is associated with adverse changes in adipose cellular function and that these variations may be involved in the biology of aging and the etiology of aging-related diseases Adipose tissue contains cells that have undergone cellular senescence which induces inflammation cytotoxicity and metabolic dysfunction in other cells and tissues However the precise role of adipose tissue cellular composition on PCC recovery is limited
Thus the investigators propose to evaluate the role of obesity and PCC on physical functioning health-related quality of life HRQOL and systemic and adipose tissue inflammatory and cellular senescence profiles in ethnically diverse older Veterans from the Audie Murphy San Antonio and Baltimore VA Medical Centers Further the investigators propose a randomized controlled trial to determine whether a reduction in body weight and increased physical function by a weight loss intervention WL including dietary modification and exercise in obese Veterans with PCC will reduce systemic and adipose tissue inflammation and senescence which will have important implications for PCC recovery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1I01RX004572-01A1 | NIH | None | httpsreporternihgovquickSearch1I01RX004572-01A1 |