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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Контакты исследования
- Имя: Elena Volpi, MD, PhD
- Номер телефона: (210) 562- 6139
- Электронная почта: volpi@uthscsa.edu
Учебное резервное копирование контактов
- Имя: Eloisa Martinez
- Номер телефона: 210-562-5078
- Электронная почта: martineze42@uthscsa.edu
Места учебы
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Texas
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San Antonio, Texas, Соединенные Штаты, 78229
- South Texas Veterans Health Care System
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Контакт:
- Dean L Jr. Kellogg, MD, PhD
- Номер телефона: 210 617 5311
- Электронная почта: KelloggD@uthscsa.edu
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San Antonio, Texas, Соединенные Штаты, 78207
- Texas Diabetes Institute
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Контакт:
- Renata Belfort De Aguiar, MD, PhD
- Номер телефона: 210 -358 -7229
- Электронная почта: belfortda@uthscsa.edu
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San Antonio, Texas, Соединенные Штаты, 78229
- Sam and Ann Barshop Institute for Longevity & Aging Studies
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Контакт:
- Tiffany Cortes, MD
- Номер телефона: 210 450 8998
- Электронная почта: cortest@uthscsa.edu
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San Antonio, Texas, Соединенные Штаты, 78227
- San Antonio Food Bank
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Контакт:
- Shreya Rao, MD
- Номер телефона: 210 567 4600
- Электронная почта: raos4@uthscsa.edu
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San Antonio, Texas, Соединенные Штаты, 78229
- Barshop Institute Mobile Research Clinic
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Контакт:
- Shreya Rao, MD
- Номер телефона: 210 567 4600
- Электронная почта: raos4@uthscsa.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
Другие имена:
Participants will take two placebo pills daily for 36 months
Другие имена:
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Экспериментальный: Dapagliflozin Arm
Dapagliflozin and semaglutide placebo are administered |
Participants will take two placebo pills daily for 36 months
Другие имена:
Participants will take one dapagliflozin plus one placebo pill daily for 36 months
Другие имена:
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Плацебо Компаратор: 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
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Continuous Short Physical Performance Battery SPPB
Временное ограничение: 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)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Physiological reserve
Временное ограничение: 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)
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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6-minute Walk Test
Временное ограничение: Baseline to end of study (approximately 36 months)
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Distance walked at self-selected normal pace over 6 minutes |
Baseline to end of study (approximately 36 months)
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Grip strength
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
|
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Glycosolated hemoglobin (HbA1c)
Временное ограничение: Baseline to end of study (approximately 36 months)
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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
Временное ограничение: Baseline to end of study (approximately 36 months)
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Body weight (kg) |
Baseline to end of study (approximately 36 months)
|
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Body mass index (BMI)
Временное ограничение: Baseline to 36 weeks
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Body mass index is calculated using weight (kg) and height (meters) |
Baseline to 36 weeks
|
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Visual acuity
Временное ограничение: Baseline to end of study (approximately 36 months)
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Measured using Snellen test |
Baseline to end of study (approximately 36 months)
|
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Hearing thresholds (dB)
Временное ограничение: 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)
Временное ограничение: Baseline to 36 months
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Measure of peak expiratory flow (FEV1) using a portable spirometer. |
Baseline to 36 months
|
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Fat free mass
Временное ограничение: Baseline to end of study (approximately 36 months)
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Measured by Bioelectrical Impedance Analysis (BIA) |
Baseline to end of study (approximately 36 months)
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Body fat percentage
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: Baseline to end of study (approximately 36 months)
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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)
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY00002818
- ARPA-H/1AY2AX000159 - 01 (Другой номер гранта/финансирования: DHHS)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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.
Сроки обмена IPD
After study completion and when data are analyzed
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .