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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Elena Volpi, MD, PhD
- 電話番号：(210) 562- 6139
- メール：volpi@uthscsa.edu
研究連絡先のバックアップ
- 名前：Eloisa Martinez
- 電話番号：210-562-5078
- メール：martineze42@uthscsa.edu
研究場所
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Texas
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San Antonio、Texas、アメリカ、78229
- South Texas Veterans Health Care System
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コンタクト：
- Dean L Jr. Kellogg, MD, PhD
- 電話番号：210 617 5311
- メール：KelloggD@uthscsa.edu
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San Antonio、Texas、アメリカ、78207
- Texas Diabetes Institute
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コンタクト：
- Renata Belfort De Aguiar, MD, PhD
- 電話番号：210 -358 -7229
- メール：belfortda@uthscsa.edu
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San Antonio、Texas、アメリカ、78229
- Sam and Ann Barshop Institute for Longevity & Aging Studies
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コンタクト：
- Tiffany Cortes, MD
- 電話番号：210 450 8998
- メール：cortest@uthscsa.edu
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San Antonio、Texas、アメリカ、78227
- San Antonio Food Bank
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コンタクト：
- Shreya Rao, MD
- 電話番号：210 567 4600
- メール：raos4@uthscsa.edu
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San Antonio、Texas、アメリカ、78229
- Barshop Institute Mobile Research Clinic
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コンタクト：
- Shreya Rao, MD
- 電話番号：210 567 4600
- メール：raos4@uthscsa.edu
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
Participants will take two placebo pills daily for 36 months
他の名前：
|
|
実験的：Dapagliflozin Arm
Dapagliflozin and semaglutide placebo are administered |
Participants will take two placebo pills daily for 36 months
他の名前：
Participants will take one dapagliflozin plus one placebo pill daily for 36 months
他の名前：
|
|
プラセボコンパレーター：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Continuous Short Physical Performance Battery SPPB
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physiological reserve
時間枠：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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
6-minute Walk Test
時間枠：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
時間枠：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)
|
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Montreal Cognitive Assessment (MOCA)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00002818
- ARPA-H/1AY2AX000159 - 01 (その他の助成金/資金番号：DHHS)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
After study completion and when data are analyzed
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。