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Validation & Intervention Testing for Aging, Longevity and Healthspan (VITAL-H)

3 november 2026 bijgewerkt door: Elena Volpi, The University of Texas Health Science Center at San Antonio

Validation & Intervention Testing for Aging, Longevity and Healthspan (VITAL-H)

The study aims to address the gap between lifespan and healthspan (years of life free of age-related diseases and disabilities) by testing whether 2 approved U.S Food and Drug Administration (FDA) medications, dapagliflozin and semaglutide, can help people stay healthier as they age and delay the age-related functional decline. The study will test these medications over 36 months of treatment plus 6 months of observational follow up to see if they can safely maintain health and function during aging and eventually support their use for extending healthspan.

This study is being done because there are limited ways to slow down the age-related health and functional decline, and few reliable ways to measure early changes in healthspan in humans. The 2 study drugs have shown promising results in laboratory and early human studies, but more evidence is needed.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Phase 2b, hybrid-decentralized, double-blind, randomized placebo-controlled trial to evaluate the independent effects of dapagliflozin, oral semaglutide, and placebo on functional decline in healthy adults aged 60-75 years. 1200 individuals will be randomized to parallel intervention arms and followed for 36 months of intervention plus 6 months post-intervention follow-up to evaluate changes in locomotion (continuous short physical performance battery - primary outcome), vitality (peak oxygen uptake during exercise, VO2 peak - secondary outcome). Exploratory outcomes will include changes in body composition, individual components of intrinsic capacity (IC) across multiple functional geroscience-based domains, and overall intrinsic capacity. This hybrid-decentralized clinical trial integrates wearable technology, deep phenotyping, and biomarker analyses to evaluate if the proposed therapies demonstrate meaningful differences in functional healthy longevity outcomes.

Studietype

Ingrijpend

Inschrijving (Geschat)

1200

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Elena Volpi, MD, PhD
  • Telefoonnummer: (210) 562- 6139
  • E-mail: volpi@uthscsa.edu

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Texas
      • San Antonio, Texas, Verenigde Staten, 78229
        • South Texas Veterans Health Care System
        • Contact:
      • San Antonio, Texas, Verenigde Staten, 78207
        • Texas Diabetes Institute
        • Contact:
      • San Antonio, Texas, Verenigde Staten, 78229
        • Sam and Ann Barshop Institute for Longevity & Aging Studies
        • Contact:
      • San Antonio, Texas, Verenigde Staten, 78227
        • San Antonio Food Bank
        • Contact:
      • San Antonio, Texas, Verenigde Staten, 78229
        • Barshop Institute Mobile Research Clinic
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

60 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Ability to understand and the willingness to sign a written informed consent document.
  2. Males and females; Age 60-75
  3. Willingness to adhere to the study intervention regimen (dapagliflozin or semaglutide).
  4. Body mass index 20-40 kg/m2
  5. Community dwelling

Exclusion Criteria:

  1. Any medical condition that, in the opinion of the investigator, would place the participant at increased risk for participation.

  2. Participation in another treatment or intervention study within 6 months

  3. Use of the following medication or supplements

    • That may be used for weight or appetite control
    • That may be used for glucose lowering
    • Immunosuppressant or biologics

  4. Any of the following conditions

    • Myocardial infarction (MI), cerebrovascular accident (CVA/stroke), congestive heart failure (CHF) or revascularization procedures like percutaneous coronary intervention (stents)
    • Renal impairment with estimated glomerular filtration rate (eGFR<45)
    • Requirement of assistive devices for ambulation
    • Pancreatitis history (if cause has been removed then okay to enroll)
    • Recurrent urinary tract infections (2 or more within 6 months, or 3 or more within past 12 months)
    • Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
    • Active cancer (okay if in remission for ≥ 3 years or had non melanoma skin cancer)
    • Uncontrolled Hypertension above 160/90 (we will include individuals with controlled hypertension and no complications)
    • Diabetes or Hemoglobin A1c ≥6.5%
    • Multiple sclerosis, MS, Parkinson Disease, mild cognitive impairment, dementia
    • History of solid organ transplant

  5. Planned elective orthopedic surgery during the study

  6. Hypersensitivity to any of the study drugs

  7. Prisoner

  8. Females who are pregnant, breastfeeding, or planning to become pregnant

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Semaglutide Arm

Semaglutide and dapagliflozin placebo are administered
Geneesmiddel: Semaglutide oral

Participants will start taking a 1.5 mg semaglutide pill, titrated to 4 mg as tolerated, plus one placebo pill per day for 36 months.

Andere namen:
  • Weygovy pill
Ander: Placebo

Participants will take two placebo pills daily for 36 months

Andere namen:
  • Inert tablet
Experimenteel: Dapagliflozin Arm

Dapagliflozin and semaglutide placebo are administered
Ander: Placebo

Participants will take two placebo pills daily for 36 months

Andere namen:
  • Inert tablet
Geneesmiddel: Dapagliflozin 10Mg Oral Tablet

Participants will take one dapagliflozin plus one placebo pill daily for 36 months

Andere namen:
  • Farxiga 10 mg
Placebo-vergelijker: Placebo Arm

The placebo arm consists of 2 placebos, one matched to each study drug with the same ingredients for both.
Ander: Placebo

Participants will take two placebo pills daily for 36 months

Andere namen:
  • Inert tablet

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Continuous Short Physical Performance Battery SPPB
Tijdsspanne: Baseline to end of study (approximately 36 months)

This is a well-established objective measure of physical function that assesses standing balance, gait speed test, and repeated chair stands. The SPPB score ranges from 0 to 12, with higher scores indicating better lower extremity physical function.
Baseline to end of study (approximately 36 months)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physiological reserve
Tijdsspanne: Baseline to end of study (approximately 36 months)

Measured as Cardio-Pulmonary Exercise Test (CPET) on a cycle ergometer to measure maximum oxygen consumption rate (VO2 peak) during exercise during a treadmill test on a stationary bicycle.
Baseline to end of study (approximately 36 months)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
6-minute Walk Test
Tijdsspanne: Baseline to end of study (approximately 36 months)

Distance walked at self-selected normal pace over 6 minutes
Baseline to end of study (approximately 36 months)
Grip strength
Tijdsspanne: Baseline to end of study (approximately 36 months)

Isometric hand grip strength during a 3-5 second period
Baseline to end of study (approximately 36 months)
Montreal Cognitive Assessment (MOCA)
Tijdsspanne: Baseline to end of study (approximately 36 months)

Participants will complete the MOCA a brief cognitive screening tool used to assess cognitive function on person or remotely, as applicable. Scores are calculated according to the standardized scoring procedures for the version administered, with higher scores indicating better cognitive function.
Baseline to end of study (approximately 36 months)
Center for Epidemiological Studies Depression Scale (CES-D)
Tijdsspanne: Baseline to end of study (approximately 36 months)

Total scores range from 0 to 60, with higher scores indicating greater depressive symptom burden.
Baseline to end of study (approximately 36 months)
Glycosolated hemoglobin (HbA1c)
Tijdsspanne: Baseline to end of study (approximately 36 months)

Percentage of glucose in hemoglobin averaged over a 3 month period
Baseline to end of study (approximately 36 months)
Body weight
Tijdsspanne: Baseline to end of study (approximately 36 months)

Body weight (kg)
Baseline to end of study (approximately 36 months)
Body mass index (BMI)
Tijdsspanne: Baseline to 36 weeks

Body mass index is calculated using weight (kg) and height (meters)
Baseline to 36 weeks
Visual acuity
Tijdsspanne: Baseline to end of study (approximately 36 months)

Measured using Snellen test
Baseline to end of study (approximately 36 months)
Hearing thresholds (dB)
Tijdsspanne: Baseline to end of study (approximately 36 months)

Hearing is tested using a hand-held portable audiometer at various frequencies.
Baseline to end of study (approximately 36 months)
Pulmonary Function (FEV1)
Tijdsspanne: Baseline to 36 months

Measure of peak expiratory flow (FEV1) using a portable spirometer.
Baseline to 36 months
Fat free mass
Tijdsspanne: Baseline to end of study (approximately 36 months)

Measured by Bioelectrical Impedance Analysis (BIA)
Baseline to end of study (approximately 36 months)
Body fat percentage
Tijdsspanne: Baseline to end of study (approximately 36 months)

Measured by Bioelectrical Impedance Analysis (BIA)
Baseline to end of study (approximately 36 months)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tijdsspanne: Baseline to end of study (approximately 36 months)

calculated from fasting insulin and fasting glucose
Baseline to end of study (approximately 36 months)
Nutritional Status
Tijdsspanne: Baseline to end of study (approximately 36 months)

Mini Nutritional Assessment (MNA) is a 6-item screening tool with total scores ranging from 0 to 14. Scores of 12-14 indicate normal nutritional status, 8-11 indicate risk of malnutrition, and 0-7 indicate malnourished.
Baseline to end of study (approximately 36 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The University of Texas Health Science Center at San Antonio

Medewerkers

Department of Health and Human Services

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

1 december 2030

Studie voltooiing (Geschat)

1 februari 2031

Studieregistratiedata

Eerst ingediend

26 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 november 2026

Eerst geplaatst (Werkelijk)

6 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00002818
  • ARPA-H/1AY2AX000159 - 01 (Ander subsidie-/financieringsnummer: DHHS)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Only deidentified individual participant data (IPD) will be shared with the entitites involved at sites used for the study and possibly the data safety monitoring board if needed. Any public data will be shared as aggregated data on ClinicalTrials.gov or in a peer review journal.

IPD-tijdsbestek voor delen

After study completion and when data are analyzed

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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