Active not recruitingPHASE2INTERVENTIONAL

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

This research is looking into two natural body chemicals called Apelin and Relaxin. We think they might help people with heart and blood vessel problems, especially those with type 2 diabetes. Type 2 diabetes can lead to serious health issues like heart disease, even with current treatments. We hope these substances could improve how your body uses sugar and help your heart work better. This early-stage study will test how Apelin and Relaxin affect blood flow and body processes in healthy volunteers, people who are overweight, and those with type 2 diabetes. The aim is to see if they could be developed into new treatments.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

170

Start

28 Mar 2018

Estimated completion

01 Dec 2026

Cardiovascular Diseases Type 2 Diabetes Mellitus

What is this study about?

Type 2 diabetes is a common, long-term health condition where your body struggles to manage sugar levels in your blood. This can happen if your body doesn't produce enough insulin, or if it can't use the insulin it makes properly. Being overweight or not exercising enough can increase your risk. Over time, high blood sugar can damage small and large blood vessels, leading to serious problems like heart disease, kidney issues, nerve damage, and eye problems.

While there are many treatments for type 2 diabetes, these complications can still happen. This means we urgently need to find new ways to help. This study is exploring two natural substances found in the body, called Apelin and Relaxin. Both have been shown to help blood vessels relax and widen, which could be good for your heart and blood flow. We also think they might help improve how your body handles sugar, which is important for type 2 diabetes.

The main goal of this study is to test these ideas. We want to see how Apelin and Relaxin affect blood flow and other body processes in people. By understanding how these natural substances work, we hope to find new ways to treat type 2 diabetes and prevent its complications, helping people live healthier lives.

Key takeaways

This study explores natural body chemicals (Apelin, Relaxin) for type 2 diabetes and heart health.
It aims to find new ways to improve sugar control and protect the heart.
Participation involves clinic visits, blood tests, and receiving study medications.
The study includes healthy people, those overweight, and people with type 2 diabetes.
It's an early-stage study, focusing on understanding how these substances work.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for volunteers between 18 and 70 years old. We are inviting people from three different groups: healthy individuals, those who are overweight, and people with type 2 diabetes. Everyone must be a non-smoker.

If you're a woman, you'll need to be past menopause or, if you still have periods, be within a certain time of your menstrual cycle and have a negative pregnancy test on the day of your visit. There are also specific weight and body fat requirements depending on which group you fit into. For example, some groups have stricter weight limits than others.

There are also some reasons why you wouldn't be able to join. These include being allergic to any of the study medications, having very high or very low blood pressure, or having known heart disease or an implanted heart device like a pacemaker.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Are you a non-smoker?
Do you have a documented diagnosis of Type 2 Diabetes (if applying for that group)?
Are you able to attend several clinic visits?
Do you have known heart disease or an implanted pacemaker? (If yes, you may not be eligible.)

Answer every question to see your result.

What does participation involve?

This is an early-stage study, which means we are carefully testing new approaches. We'll be looking at how your body responds to Apelin or Relaxin, or other standard treatments, over a short period. Taking part will involve several visits to the study clinic, where you might have your blood pressure checked, blood samples taken, and other tests to see how your blood flow and metabolism are working. You will receive either Apelin, Relaxin, a saline (saltwater) solution as a comparison, or other medications like Verapamil or LN Monomethyl arginine. The total duration of your participation will depend on the specific part of the study you join, but it typically involves a few clinic visits and careful monitoring by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that we might learn valuable information about new ways to treat type 2 diabetes and related heart conditions, which could help future patients. However, there's no guarantee that you will personally benefit from taking part. The substances Apelin and Relaxin are natural body chemicals and have been used in previous studies without significant side effects. Still, as with any medication, there's a chance of side effects or allergic reactions. All risks and benefits will be fully explained before you agree to take part, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom

Common questions

What are Apelin and Relaxin?

They are natural chemicals (peptides) your body produces. We think they might help improve blood flow and how your body uses sugar.

Why is this study important for type 2 diabetes?

Type 2 diabetes can lead to heart problems. We're looking for new treatments that could help manage blood sugar and protect the heart better than current options.

Will I receive treatment for my diabetes if I join?

This is a research study, not a standard treatment. You will receive a study drug, but it's for investigation purposes, not routine care. Your usual diabetes care will continue.

Is there a chance I might not get Apelin or Relaxin?

Yes, some participants will receive a saline (saltwater) solution or other standard medications as a comparison, so we can properly test the effects of Apelin and Relaxin.

Can I leave the study if I change my mind?

Absolutely. You can withdraw from the study at any time, for any reason, without it affecting your current or future medical care.