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

2026年11月3日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

1200

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Elena Volpi, MD, PhD
  • 电话号码：(210) 562- 6139
  • 邮箱：volpi@uthscsa.edu

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Semaglutide Arm

Semaglutide and dapagliflozin placebo are administered
药品：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.

其他名称：
  • Weygovy pill
其他：Placebo

Participants will take two placebo pills daily for 36 months

其他名称：
  • 惰性药片
实验性的：Dapagliflozin Arm

Dapagliflozin and semaglutide placebo are administered
其他：Placebo

Participants will take two placebo pills daily for 36 months

其他名称：
  • 惰性药片
药品：Dapagliflozin 10Mg Oral Tablet

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

其他名称：
  • 法西加 10 毫克
安慰剂比较：Placebo Arm

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

Participants will take two placebo pills daily for 36 months

其他名称：
  • 惰性药片

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Continuous Short Physical Performance Battery SPPB
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Physiological reserve
大体时间：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)

其他结果措施

结果测量
措施说明
大体时间
6-minute Walk Test
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：Baseline to end of study (approximately 36 months)

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

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

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

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The University of Texas Health Science Center at San Antonio

合作者

Department of Health and Human Services

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2030年12月1日

研究完成 (估计的)

2031年2月1日

研究注册日期

首次提交

2026年10月26日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00002818
  • ARPA-H/1AY2AX000159 - 01 (其他赠款/资助编号：DHHS)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

After study completion and when data are analyzed

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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