Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

Obesity Clinical Trial

— MARVEL  

Official title:

Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880108
• Other study ID #: F4572-R
• Secondary ID: 1I01RX004572-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: September 30, 2028

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Monica C Serra, PhD
• Phone: (814) 332-9939
• Email: Monica.Serra[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2028
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Obesity

Intervention

Behavioral:
• 12-weeks of Weight Loss
Participants will be asked to participate in a 1x/week center-based nutrition diet class, 2x/week center-based exercise classes, and 1x/week exercise session conducted on their own for 12 weeks.
• 12-weeks of Weight Stability
Participants will be asked to participate in a 1x/week center-based health education class, 2x/week center-based stretching/balance classes, and 1x/week stretching/balance session conducted on their own for 12 weeks.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	South Texas Health Care System, San Antonio, TX	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Baltimore VA Medical Center, South Texas Veterans Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory Fitness (VO2max)	VO2max (ml/kg/min) comparison between lean PCC naïve, lean with PCC, obese PCC naïve, and obese with PCC	Baseline
Secondary	Change in Cardiorespiratory Fitness (VO2max)	Change in VO2max (L/min)	Baseline, After 12 weeks of Weight Loss
Secondary	Change in adipose tissue cellular senescence	Change in adipose tissue chemokine (C-C motif) ligand 3 (CCL3)	Baseline, After 12 weeks of Weight Loss