Validation & Intervention Testing for Aging, Longevity and Healthspan (VITAL-H)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Elena Volpi, MD, PhD
- Telefonní číslo: (210) 562- 6139
- E-mail: volpi@uthscsa.edu
Studijní záloha kontaktů
- Jméno: Eloisa Martinez
- Telefonní číslo: 210-562-5078
- E-mail: martineze42@uthscsa.edu
Studijní místa
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Texas
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San Antonio, Texas, Spojené státy, 78229
- South Texas Veterans Health Care System
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Kontakt:
- Dean L Jr. Kellogg, MD, PhD
- Telefonní číslo: 210 617 5311
- E-mail: KelloggD@uthscsa.edu
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San Antonio, Texas, Spojené státy, 78207
- Texas Diabetes Institute
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Kontakt:
- Renata Belfort De Aguiar, MD, PhD
- Telefonní číslo: 210 -358 -7229
- E-mail: belfortda@uthscsa.edu
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San Antonio, Texas, Spojené státy, 78229
- Sam and Ann Barshop Institute for Longevity & Aging Studies
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Kontakt:
- Tiffany Cortes, MD
- Telefonní číslo: 210 450 8998
- E-mail: cortest@uthscsa.edu
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San Antonio, Texas, Spojené státy, 78227
- San Antonio Food Bank
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Kontakt:
- Shreya Rao, MD
- Telefonní číslo: 210 567 4600
- E-mail: raos4@uthscsa.edu
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San Antonio, Texas, Spojené státy, 78229
- Barshop Institute Mobile Research Clinic
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Kontakt:
- Shreya Rao, MD
- Telefonní číslo: 210 567 4600
- E-mail: raos4@uthscsa.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent document.
- Males and females; Age 60-75
- Willingness to adhere to the study intervention regimen (dapagliflozin or semaglutide).
- Body mass index 20-40 kg/m2
- Community dwelling
Exclusion Criteria:
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Any medical condition that, in the opinion of the investigator, would place the participant at increased risk for participation.
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Participation in another treatment or intervention study within 6 months
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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
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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
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Planned elective orthopedic surgery during the study
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Hypersensitivity to any of the study drugs
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Prisoner
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Females who are pregnant, breastfeeding, or planning to become pregnant
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Semaglutide Arm
Semaglutide and dapagliflozin placebo are administered |
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.
Ostatní jména:
Participants will take two placebo pills daily for 36 months
Ostatní jména:
|
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Experimentální: Dapagliflozin Arm
Dapagliflozin and semaglutide placebo are administered |
Participants will take two placebo pills daily for 36 months
Ostatní jména:
Participants will take one dapagliflozin plus one placebo pill daily for 36 months
Ostatní jména:
|
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Komparátor placeba: Placebo Arm
The placebo arm consists of 2 placebos, one matched to each study drug with the same ingredients for both. |
Participants will take two placebo pills daily for 36 months
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Continuous Short Physical Performance Battery SPPB
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Physiological reserve
Časové okno: 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)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
6-minute Walk Test
Časové okno: 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)
|
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Grip strength
Časové okno: Baseline to end of study (approximately 36 months)
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Isometric hand grip strength during a 3-5 second period |
Baseline to end of study (approximately 36 months)
|
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Montreal Cognitive Assessment (MOCA)
Časové okno: 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)
|
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Center for Epidemiological Studies Depression Scale (CES-D)
Časové okno: 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)
Časové okno: 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)
|
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Body weight
Časové okno: Baseline to end of study (approximately 36 months)
|
Body weight (kg) |
Baseline to end of study (approximately 36 months)
|
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Body mass index (BMI)
Časové okno: Baseline to 36 weeks
|
Body mass index is calculated using weight (kg) and height (meters) |
Baseline to 36 weeks
|
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Visual acuity
Časové okno: Baseline to end of study (approximately 36 months)
|
Measured using Snellen test |
Baseline to end of study (approximately 36 months)
|
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Hearing thresholds (dB)
Časové okno: 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)
|
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Pulmonary Function (FEV1)
Časové okno: Baseline to 36 months
|
Measure of peak expiratory flow (FEV1) using a portable spirometer. |
Baseline to 36 months
|
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Fat free mass
Časové okno: Baseline to end of study (approximately 36 months)
|
Measured by Bioelectrical Impedance Analysis (BIA) |
Baseline to end of study (approximately 36 months)
|
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Body fat percentage
Časové okno: Baseline to end of study (approximately 36 months)
|
Measured by Bioelectrical Impedance Analysis (BIA) |
Baseline to end of study (approximately 36 months)
|
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Časové okno: Baseline to end of study (approximately 36 months)
|
calculated from fasting insulin and fasting glucose |
Baseline to end of study (approximately 36 months)
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Nutritional Status
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00002818
- ARPA-H/1AY2AX000159 - 01 (Jiné číslo grantu/financování: DHHS)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení IPD
After study completion and when data are analyzed
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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