The LIMIting AAA with meTformin (LIMIT) Trial
使用二甲双胍限制 AAA (LIMIT) 试验
基本信息
- 批准号:10054902
- 负责人:
- 金额:$ 153.25万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-09-21 至 2022-06-30
- 项目状态:已结题
- 来源:
- 关键词:Abdominal Aortic AneurysmAddressAdultAmericanAnalysis of VarianceAneurysmAortic AneurysmBiological ProcessBlood specimenCaliberCardiovascular DiseasesCardiovascular ManifestationCardiovascular systemCaringCentrifugationCessation of lifeClinical TrialsComputerized Medical RecordConcurrent ReviewDataDiabetes MellitusDiet ModificationDiseaseDisease ManagementDisease ProgressionDoseDrug usageFRAP1 geneGoalsGrowthHealth BenefitHematologyHuman BiologyHypoglycemic AgentsIndividualInterventionLocationMedicalMedical RecordsMedicareMetabolicMetforminMonitorNuclearOperative Surgical ProceduresOralParticipantPathway interactionsPatientsPeriodicityPharmaceutical PreparationsPhysical ExaminationPlacebosPrevalenceProductionProtein FamilyPublic HealthQuality of lifeRandomizedReactive Oxygen SpeciesRetrospective StudiesRiskRuptureRuptured Abdominal Aortic AneurysmSafetySourceStratificationSudden DeathSurveysTest ResultTestingTranslational ResearchUnited States National Institutes of HealthVisionX-Ray Computed Tomographyangiogenesiscostcost estimatediabetes managementdiabeticdiabetic patientdisabilitygastrointestinalhuman diseasemacrophagenon-diabeticnovelnovel therapeuticsprematurepreventprimary endpointprogramsprospectiveprospective testrepairedresilienceresponsescreeningtheoriestreatment effect
项目摘要
Project Summary
Abdominal aortic aneurysm (AAA) disease is a common cause of premature death in adult
Americans. To date, no medical (e.g., non-surgical) therapies have proven effective at limiting AAA disease
progression, or reducing the risk of AAA rupture or aneurysm-related sudden death.
The recognition that diabetic individuals are less likely to develop AAAs and when present in diabetics,
AAAs enlarge less rapidly and rupture less frequently, introduces new possibilities for medical AAA disease
management. Recent retrospective studies suggest that metformin, the world’s most commonly prescribed oral
hypoglycemic agent, may be associated with reduced rates of AAA enlargement. To date, however, the ability
of metformin to suppress AAA disease has not been evaluated in a scientifically rigorous, prospective fashion.
Building off existing observational evidence and novel preliminary data, generated to support this proposal,
it is our fundamental hypothesis that metformin therapy will safely suppress AAA disease progression in non-
diabetic patients. To test this hypothesis, two Specific Aims are proposed. The First Aim will evaluate the
tolerability and safety of metformin in nondiabetic patients with AAA disease. Tolerance will be assessed by the
serial administration of quality of life surveys and tracking participant compliance and retention. Safety will be
assessed by semi-annual examinations, review of the source medical record, supplementary hematologic and
metabolic panel surveys as needed. The Second Aim will test the ability of metformin XR (extended release)
to reduce the average annual rate of enlargement of existing small to intermediate size AAAs by ≥ 30%
compared to placebo. For this Aim, 480 participants will be randomized 1:1 to metformin or placebo. The
primary endpoint will be the increase in mean maximal orthogonal AAA diameter through 24 months, as
determined by computed tomographic aortography (CTA). Successful completion of these Aims will advance
the understanding of AAA disease as well as the translational utility of metformin therapy to treat
cardiovascular diseases in nondiabetic patients.
These Aims specifically address the NIH Strategic Vision Goals of 1) understanding human biology, 2)
reducing human disease, and 3) advancing translational research, as well as Objectives of 1) understanding
normal biologic function and resilience, 2) investigating newly discovered pathobiological mechanisms, and 3)
developing and optimizing novel therapeutic strategies to prevent, treat and cure HLBS diseases.
项目总结
项目成果
期刊论文数量(0)
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{{ truncateString('RONALD L DALMAN', 18)}}的其他基金
The LIMIting AAA with meTformin (LIMIT) Trial
使用二甲双胍限制 AAA (LIMIT) 试验
- 批准号:
10274809 - 财政年份:2020
- 资助金额:
$ 153.25万 - 项目类别:
The LIMIting AAA with meTformin (LIMIT) Trial
使用二甲双胍限制 AAA (LIMIT) 试验
- 批准号:
10650132 - 财政年份:2020
- 资助金额:
$ 153.25万 - 项目类别:
Mechanisms and Significance of Angiogenesis in AAA Disease
AAA 疾病中血管生成的机制和意义
- 批准号:
8228228 - 财政年份:2012
- 资助金额:
$ 153.25万 - 项目类别:
Mechanisms and Significance of Angiogenesis in AAA Disease
AAA 疾病中血管生成的机制和意义
- 批准号:
8403798 - 财政年份:2012
- 资助金额:
$ 153.25万 - 项目类别:
Critical Role of Inflammatory Macrophages in AAA Pathogenesis
炎症巨噬细胞在 AAA 发病机制中的关键作用
- 批准号:
8179456 - 财政年份:2011
- 资助金额:
$ 153.25万 - 项目类别:
Critical Role of Inflammatory Macrophages in AAA Pathogenesis
炎症巨噬细胞在 AAA 发病机制中的关键作用
- 批准号:
8312534 - 财政年份:2011
- 资助金额:
$ 153.25万 - 项目类别:
2008 Stanford AAA Summit: Strategies for Multidisciplinary Research
2008 年斯坦福 AAA 峰会:多学科研究策略
- 批准号:
7614944 - 财政年份:2008
- 资助金额:
$ 153.25万 - 项目类别:
Stanford Career Development in Vascular Medicine
斯坦福血管医学职业发展
- 批准号:
8324232 - 财政年份:2007
- 资助金额:
$ 153.25万 - 项目类别:
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