CompletedNot ApplicableInterventional

Does an infusion of alpha-melanocyte stimulating hormone reduce blood sugar after a sugary drink in healthy people and those with type 1 diabetes mellitus?

People with diabetes often experience sharp blood sugar spikes after meals. Over time, high blood sugar can cause serious complications, such as heart disease and kidney problems. While insulin is an essential treatment, it can sometimes cause blood sugar to drop dangerously low or lead to unwanted weight gain. Scientists recently discovered that a natural hormone called alpha-MSH helps lower blood sugar in animals by helping insulin work better. This study aims to find out if the same is true in humans. Running in London and Northern Ireland, the study welcomes healthy adults and adults with type 1 diabetes aged 18 to 50. Volunteers will receive a drip containing either the hormone or harmless saltwater, drink a sugary drink, and have blood samples taken over several hours. The findings could guide future, gentler treatments for blood sugar control.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

Imperial College London

Enrolment target

Start

15 Sep 2020

Estimated completion

31 Oct 2024

Glucose clearance from the blood

What is this study about?

When we eat, our bodies turn food into sugar (glucose), which travels into the bloodstream. A hormone called insulin acts like a key, letting that sugar into our cells to be used for energy. In people with type 1 diabetes, the body cannot make insulin, causing sugar to build up in the blood. Over many years, high blood sugar can damage delicate blood vessels and harm vital organs, including the heart, kidneys, and eyes.

Insulin injections are life-saving, but balancing the dose can be tricky. Giving slightly too much insulin can lead to 'hypos' (very low blood sugar), which can cause shakiness, confusion, or even fainting. It can also cause gradual weight gain. Because of this, researchers are eager to find new ways to support blood sugar balance without these unwanted side effects.

This trial focuses on a natural hormone produced by the brain, known as alpha-melanocyte stimulating hormone (alpha-MSH). In animal experiments, alpha-MSH helped clear sugar from the blood more effectively by improving sensitivity to insulin. Scientists at Imperial College London and Ulster University are now testing this hormone in humans for the first time.

By comparing what happens in healthy volunteers and people with type 1 diabetes, doctors hope to gain a clear picture of how alpha-MSH affects human metabolism. While taking part will not cure diabetes, the research could lay the groundwork for brand-new medicines in the years ahead.

Key takeaways

Researchers are testing if a natural brain hormone (alpha-MSH) can help manage blood sugar spikes after food.
The study includes both healthy volunteers and people living with type 1 diabetes aged 18 to 50.
Participation involves clinic visits lasting 4 to 6 hours for drips, a sugary drink, and regular blood tests.
Side effects are usually mild and temporary, such as feeling warm in the face or slight nausea.
Taking part is voluntary and does not replace your routine diabetes management.

Who may be eligible?

This study is open to men and women aged 18 to 50. To be eligible, your weight must have been steady for at least the past three months, and your Body Mass Index (BMI) should be between 18 and 30, meaning you are neither underweight nor living with obesity. Healthy volunteers can take part in the first two parts of the trial, while adults with type 1 diabetes are invited to take part in the third part.

Because your safety is the top priority, you cannot take part if you have certain existing health conditions. These include heart disease, high blood pressure, breathing problems, liver or kidney disease, or serious mental health conditions. Healthy volunteers must also have no history of diabetes.

You will also not be able to join if you take regular prescription medicines that could affect blood sugar tests, or if you have known allergies to hormone-like proteins. You must be comfortable speaking, reading, and understanding English so you can follow study instructions and give your informed consent.

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.

I am between 18 and 50 years of age.
My body weight has been stable for the last 3 months.
My Body Mass Index (BMI) is between 18 and 30.
I am either in good health with no diabetes, or I have been diagnosed with type 1 diabetes.
I do not have a history of heart, kidney, liver, or significant mental health conditions.
I am able to read and understand English to complete study forms.

Answer every question to see your result.

What does participation involve?

Taking part involves attending a specialist hospital clinic for between two and six visits, depending on which part of the trial you join. During each visit, you will rest in a comfortable chair while receiving an infusion (a slow drip into a vein in your arm) of either the alpha-MSH hormone or plain saltwater. You will also drink a standard sugary drink. Over the next 4 to 6 hours, the research team will take small blood samples at regular intervals to track your sugar, insulin, and hormone levels. In some sessions, carefully controlled amounts of insulin and glucose may be given through the drip to test your insulin response in detail. A qualified medical doctor will stay with you throughout the test. The whole study is scheduled to run until late 2024.

Potential risks and benefits

There is no direct medical benefit to your own health from joining this study, though you will be helping researchers discover new ways to treat diabetes in the future. The risks are considered very low because alpha-MSH has been tested safely in people before. Some participants may notice brief facial flushing (a warm, red face) or mild sickness (nausea), both of which usually pass within a few minutes. A doctor is present at all times to keep you safe and comfortable. Taking part is entirely your choice, and you are free to stop and leave the study at any point without giving a reason and without affecting your normal NHS care.

Locations (3)

Imperial College Healthcare NHS Trust
City only
London, England
Imperial College London
Approximate
London, England
Ulster University
Approximate
Coleraine, Northern Ireland

Common questions

Will taking part improve or cure my diabetes?

No. This is an early-stage study designed to answer scientific questions about how the body handles sugar, rather than a treatment to cure diabetes.

How is the study hormone given?

The hormone is given gradually into a vein in your arm using a small tube and needle (an intravenous drip).

Will having the blood tests hurt?

You may feel a brief pinch when the small needle (cannula) is placed in your vein. After that, blood samples can usually be taken through the tube without repeated needle pricks.

Are there any side effects from alpha-MSH?

The hormone is generally well tolerated, but it can occasionally cause short-lived facial flushing (feeling warm or red) or mild nausea. These usually wear off quickly.

What happens if I change my mind during the study?

You can withdraw at any time. You do not need to give an explanation, and your decision will not affect your regular medical treatment or relationship with your doctors.

How to find out more

Brett Johnson

Brett.johnson@nhs.net +44 (0)7592589553 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.