VITAL-H is a research study exploring new therapies to help people maintain their health and independence as they age.
Researchers are studying two medications already approved by the U.S. Food and Drug Administration (FDA) – dapagliflozin and semaglutide – to learn whether they may help slow age-related declines in physical function in generally healthy older adults.
Participants in the trial will be followed for 3.5 years (42 months) and randomly assigned to one of three study groups:
- Dapagliflozin (Farxiga)
- Oral semaglutide (Wegovy)
- Placebo (a pill that does not contain active study medication)
Neither participants nor the study team will know which treatment a participant is receiving during the study. Participants will take their assigned treatment for 3 years.
Throughout the study, researchers will assess several aspects of health and aging, including physical function, memory and thinking, hearing, vision, nutrition, fitness and body composition. Participants will also wear a study-provided ring that measures information such as heart rate, physical activity and sleep.
The main goal of VITAL-H is to find out if dapagliflozin or semaglutide can help older adults maintain physical function and slow age-related declines in health as they age. The study will also help researchers better understand how these medications may affect other aspects of health and aging.
You may be able to participate in VITAL-H if you:
- Are 60-75 years old
- Have a body mass index (BMI) between 20 and 40 kg/m2
- Live independently in South Texas
- Are willing to take the assigned study treatment and complete study visits and procedures
- Are able and willing to provide informed consent
Additional eligibility requirements apply and will be reviewed with you by the study team. If you are unsure if meet any of the above criteria, our team will work with you to determine whether the study may be a good fit.
- A history of a heart attack, stroke, or procedures such as a stent placement or surgery to improve blood flow to the heart.
- Significant kidney disease
- Type 1 or 2 diabetes or a hemoglobin A1c of 6.5% or higher
- Elevated blood pressure that is not well controlled on therapies (greater than 160/90 mmHg)
- The need for a cane, walker, wheelchair, or other assistive device to help with walking
- Certain neurological conditions, including multiple sclerosis, Parkinson Disease, mild cognitive impairment, or dementia
- A history of pancreatitis history (inflammation of the pancreas), unless the cause has been identified and resolved
- A history of frequent urinary tract infections
- A personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
- Active cancer or recent cancer diagnosis (within the past 3 years). Individuals with current or prior non-melanoma skin cancer may still be eligible.
- A history of solid organ transplant
- Planned elective orthopedic surgery (such as a joint replacement) during the study
- A known allergy or serious reaction to one of the study medications
- Current incarceration
This is not a complete list of eligibility requirements. The study team will review your medical history and other eligibility criteria to determine whether the study may be appropriate for you.
Participation in the study lasts about 42 months (3.5 years).
During the trial, participants will undergo comprehensive in-person testing annually and shorter assessments every 6 months. Additional remote or virtual check-ins with study staff may be used to support participants, monitor their health and safety, and help them stay on track with study activities. Study visits and assessments may include:
- Physical examinations
- Blood draws
- Memory and thinking tests
- Physical function and mobility testing
- 6-minute walking tests
- Handgrip strength testing
- Lung function testing
- Cardiopulmonary exercise testing
- DXA scans to measure body composition
- Nutritional assessments
- Questionnaires to capture information about your physical and mental health and social support
- Hearing tests
- Vision tests
Participants may receive up to $450 for completing study-related visits.
In-person study activities may take place at:
- Sam and Ann Barshop Institute for Longevity and Aging Studies
- Barshop Institute Mobile Research Clinic
- South Texas Veterans Health Care System (STVHCS)
- Texas Diabetes Institute
- San Antonio Food Bank
In some cases, the study team may be able to travel to your home or another convenient location near you to complete certain study activities. If transportation or travel to a study site may be difficult, please let a member of our study team know. We will work with you to identify options that may make participation easier.
