Clinical trial NCT05880108: Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
Official title: Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-COVID Conditions
Obesity
Keywords: COVID-19
Obesity
Senescence
Weight Loss
Exercise
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: South Texas Veterans Health Care System
name: Baltimore VA Medical Center
First posted: 2023-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Weight Loss Program (Diet and Exercise)
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. U.S. Veteran
2. No Post-COVID symptoms or at least one Post-COVID symptom lasting \>4 weeks
3. Body Mass Index: 19-25 or 30-40 kg/m2
4. Postmenopausal status for women

Exclusion Criteria:

1. Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments
2. Active inflammatory, COVID-19, autoimmune, infectious, hepatic (LFTs \> 2.5 x WNL), renal (eGFR\<45), gastrointestinal, malignant, and psychiatric disease
3. Uncontrolled diabetes (HbA1c \>10% or the current use of insulin)
4. Weight change within the past month of \>5 kg
5. History of keloid formation
6. Self-reported alcohol or drug abuse
7. Anti-coagulant medication usage

Primary outcomes:
measure: Cardiorespiratory Fitness (VO2max)
timeFrame: Baseline
Secondary outcomes:
measure: Change in Cardiorespiratory Fitness (VO2max)
timeFrame: Baseline, After 12 weeks of Weight Loss
measure: Change in adipose tissue cellular senescence
timeFrame: Baseline, After 12 weeks of Weight Loss
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
Study officials:
affiliation: South Texas Health Care System, San Antonio, TX
name: Monica C Serra, PhD
role: PRINCIPAL_INVESTIGATOR
References: