Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

3 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

1200

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Elena Volpi, MD, PhD
  • Numéro de téléphone: (210) 562- 6139
  • E-mail: volpi@uthscsa.edu

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

60 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Semaglutide Arm

Semaglutide and dapagliflozin placebo are administered
Médicament: 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.

Autres noms:
  • Weygovy pill
Autre: Placebo

Participants will take two placebo pills daily for 36 months

Autres noms:
  • Comprimé inerte
Expérimental: Dapagliflozin Arm

Dapagliflozin and semaglutide placebo are administered
Autre: Placebo

Participants will take two placebo pills daily for 36 months

Autres noms:
  • Comprimé inerte
Médicament: Dapagliflozin 10Mg Oral Tablet

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

Autres noms:
  • Farxiga 10 mg
Comparateur placebo: Placebo Arm

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

Participants will take two placebo pills daily for 36 months

Autres noms:
  • Comprimé inerte

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Continuous Short Physical Performance Battery SPPB
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Physiological reserve
Délai: 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)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
6-minute Walk Test
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: Baseline to end of study (approximately 36 months)

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

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The University of Texas Health Science Center at San Antonio

Collaborateurs

Department of Health and Human Services

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 janvier 2027

Achèvement primaire (Estimé)

1 décembre 2030

Achèvement de l'étude (Estimé)

1 février 2031

Dates d'inscription aux études

Première soumission

26 octobre 2026

Première soumission répondant aux critères de contrôle qualité

3 novembre 2026

Première publication (Réel)

6 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STUDY00002818
  • ARPA-H/1AY2AX000159 - 01 (Autre subvention/numéro de financement: DHHS)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

After study completion and when data are analyzed

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner