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A Series of Pilot Studies to Evaluate the haemoDynamic and mEtabolic Effects oF apelIn aNd rElaxin

Study acronym: DEFINE
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary and study completion dates: Sep 2025 to Dec 2026v6
  2. Notable Primary and study completion dates: Sep 2023 to Sep 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  3. Notable Primary and study completion dates: Feb 2020 to Sep 2023v4 Show 4 more changesShow less
    • Primary endpoints: 29 to 30
    • Enrollment target: 122 to 170
    • Secondary endpoints revised (28)
    • Study arms: 7 to 8
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2018 to Mar 28, 2018
    • Site details revised
    v3
  5. Minor Start date: Feb 2018 to Mar 2018v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Type two diabetes mellitus (T2DM) is a common, long term metabolic disorder characterised by hyperglycaemia (high blood glucose) resulting from insulin resistance and relative insulin insufficiency. The risk of developing insulin resistance and subsequently T2DM is increased by being overweight and also through a sedentary lifestyle. As the onset can be gradual, physiological damage may have occurred prior to diagnosis. Diabetes is associated with the development of microvascular complications (diabetic nephropathy, neuropathy, and retinopathy), and macrovascular complications (coronary artery disease, peripheral arterial disease, and stroke). While there are many treatments available for T2DM, these complications may still arise, leading to significant morbidity and mortality. There is therefore an urgent need to identify novel signalling pathways that may contribute to the development of diabetes related complications. The identification of these pathways may ultimately lead to the development of new therapies targeting better blood glucose control and preventing these subsequent complications. Both animal and human studies have indicated that two endogenous peptides, apelin and relaxin both act as vasodilators in the human cardiovascular system and could also have beneficial action in T2DM. Therefore, we aim to carry out experimental medicine studies to test this hypothesis, and explore the signalling pathway in the human vascular system.
Trial Details
NCT Number NCT03449251
Lead Sponsor Cambridge University Hospitals NHS Foundation Trust
Collaborators: University of Cambridge, AstraZeneca, MedImmune LLC
Conditions
(from sponsor)
Cardiovascular Diseases, Type 2 Diabetes Mellitus
Related terms Cardiovascular Diseases, Diabetes Mellitus, Type 2
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov