Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
Recruiting · NCT05880108 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
12-weeks of Weight Loss12-weeks of Weight Stability
What this trial is about
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.
Who can take part
Age range
Up to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- U.S. Veteran
- Self-reported COVID-19 naïve or COVID-19 \> 90 days ago for lean and obese PCC naïve or documented COVID-19 for the lean and obese PCC groups (At least one PCC symptom \>4 weeks)
- Body Mass Index: 19-25 or 30-50 kg/m2
Exclusion criteria
- Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments
- Active inflammatory, COVID-19, autoimmune, infectious, hepatic (LFTs \> 2.5 x WNL), renal (eGFR\<45), gastrointestinal, malignant, and psychiatric disease
- Uncontrolled diabetes (HbA1c \>10% or the current use of insulin)
- Weight change within the past month of \>5 kg
- Self-reported alcohol or drug abuse
- Anti-coagulant medication usage
Where it is running
2 locations listed across 2 US 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, United States