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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Elena Volpi, MD, PhD
- 전화번호: (210) 562- 6139
- 이메일: volpi@uthscsa.edu
연구 연락처 백업
- 이름: Eloisa Martinez
- 전화번호: 210-562-5078
- 이메일: martineze42@uthscsa.edu
연구 장소
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Texas
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San Antonio, Texas, 미국, 78229
- South Texas Veterans Health Care System
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연락하다:
- Dean L Jr. Kellogg, MD, PhD
- 전화번호: 210 617 5311
- 이메일: KelloggD@uthscsa.edu
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San Antonio, Texas, 미국, 78207
- Texas Diabetes Institute
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연락하다:
- Renata Belfort De Aguiar, MD, PhD
- 전화번호: 210 -358 -7229
- 이메일: belfortda@uthscsa.edu
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San Antonio, Texas, 미국, 78229
- Sam and Ann Barshop Institute for Longevity & Aging Studies
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연락하다:
- Tiffany Cortes, MD
- 전화번호: 210 450 8998
- 이메일: cortest@uthscsa.edu
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San Antonio, Texas, 미국, 78227
- San Antonio Food Bank
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연락하다:
- Shreya Rao, MD
- 전화번호: 210 567 4600
- 이메일: raos4@uthscsa.edu
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San Antonio, Texas, 미국, 78229
- Barshop Institute Mobile Research Clinic
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연락하다:
- Shreya Rao, MD
- 전화번호: 210 567 4600
- 이메일: raos4@uthscsa.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
Participants will take two placebo pills daily for 36 months
다른 이름들:
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실험적: Dapagliflozin Arm
Dapagliflozin and semaglutide placebo are administered |
Participants will take two placebo pills daily for 36 months
다른 이름들:
Participants will take one dapagliflozin plus one placebo pill daily for 36 months
다른 이름들:
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위약 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Continuous Short Physical Performance Battery SPPB
기간: Baseline to end of study (approximately 36 months)
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physiological reserve
기간: Baseline to end of study (approximately 36 months)
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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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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6-minute Walk Test
기간: 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
기간: 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)
기간: Baseline to end of study (approximately 36 months)
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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)
기간: Baseline to end of study (approximately 36 months)
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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)
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: Baseline to end of study (approximately 36 months)
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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)
기간: 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
기간: 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
기간: 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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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
기간: Baseline to end of study (approximately 36 months)
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calculated from fasting insulin and fasting glucose |
Baseline to end of study (approximately 36 months)
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Nutritional Status
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00002818
- ARPA-H/1AY2AX000159 - 01 (기타 보조금/기금 번호: DHHS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
After study completion and when data are analyzed
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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