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ACTIVE NOT RECRUITING
NCT03449251
PHASE2

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

Sponsor: Cambridge University Hospitals NHS Foundation Trust

View on ClinicalTrials.gov

Summary

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.

Official title: A Series of Pilot Studies to Evaluate the Haemodynamic and Metabolic Effects of Apelin and Relaxin in Healthy Humans, Subjects With Increased Weight and Patients With Type 2 Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2018-03-28

Completion Date

2026-12

Last Updated

2026-09-30

Healthy Volunteers

Yes

Interventions

DRUG

Apelin

Apelin is an endogenous peptide that activate a single G-protein couple receptor. Apelin inhibits insulin secretion, decreases glucose levels and increases insulin sensitivity.

DRUG

Relaxin

Relaxin is RLN2 encoded endogenous peptide hormone, which binds to G protein coupled receptor RXFP1.

DRUG

Normal saline

Vehicle

DIAGNOSTIC_TEST

Verapamil

NO independent challenge agent

DIAGNOSTIC_TEST

LN Monomethyl arginine

Basal NO synthase inhibitor

Locations (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom