Obesity Clinical Trial - Modifying Adiposity Through Behavioral Strategies

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05880108
Study type	Interventional
Source	VA Office of Research and Development
Contact	Monica C Serra, PhD
Phone	(814) 332-9939
Email	Monica.Serra@va.gov
Status	Recruiting
Phase	N/A
Start date	June 3, 2024
Completion date	September 30, 2028

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation — MARVEL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms