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RecruitingNot ApplicableInterventional

Investigating the impact of glucagon timing and protein replacement on metabolism

Obesity and fatty liver disease affect millions of people across the UK. Scientists are developing new medicines based on glucagon, a natural hormone that helps the body burn calories and clears fat from the liver. However, glucagon can also reduce levels of amino acids in the blood, which are vital for maintaining healthy muscles. This trial at Hammersmith Hospital in London tests whether giving glucagon at specific times, or adding extra protein to meals, can protect these muscle-building blocks. Volunteers aged 18 to 65 with a BMI between 25 and 45 and normal blood sugar may be able to join. Taking part involves four separate hospital stays of three nights each. Volunteers receive either glucagon or a dummy treatment through a small tube in their arm. The results will help doctors design safer, more effective weight-management treatments.

At a glance

Status
Recruiting
Phase
Not Applicable
Sponsor
Imperial College London
Enrolment target
10
Start
06 Jun 2024
Estimated completion
01 Jul 2027

What is this study about?

Obesity and fatty liver disease are very common in the UK, affecting roughly one in three adults. Having excess fat in the liver can increase the risk of serious health conditions, including type 2 diabetes. To tackle this, researchers are studying treatments based on natural body hormones. One key hormone is glucagon, which helps boost calorie burning and clears fat from both the liver and the bloodstream.

However, earlier research shows that glucagon treatments can lower the amount of amino acids circulating in the blood. Amino acids are the basic building blocks your body uses to build and repair muscle. Doctors are concerned that if amino acid levels stay low for too long, a person might lose muscle mass, which is vital for strength, mobility, and long-term metabolic health.

This clinical study aims to solve that problem. Researchers want to find out whether changing the time of day glucagon is given can keep amino acid levels steady. They are also testing whether eating extra protein can help shield muscle tissue. By fine-tuning how glucagon is given, scientists hope to create weight-loss treatments that burn body fat without causing unwanted muscle loss.

Key takeaways

  • Tests whether changing glucagon timing or adding protein prevents muscle-building blocks from dropping.
  • Glucagon is a natural hormone that helps clear liver fat and burn calories.
  • Requires four separate 3-night stays at Hammersmith Hospital in London.
  • Open to adults aged 18 to 65 with a BMI between 25 and 45 and normal blood sugar.
  • Participants receive either glucagon or a harmless dummy treatment through an arm drip.

Who may be eligible?

You may be able to join this trial if you are between 18 and 65 years old and have a body mass index (BMI) between 25 and 45 kg/m². Your weight must have been stable for at least three months, and your blood sugar levels must be within the normal range.

You will not be able to take part if you have diabetes, have had weight-loss surgery, or are pregnant or breastfeeding. The study is also not suitable for people who drink more than 14 units of alcohol per week, have donated blood in the last three months, or have ongoing liver, pancreas, or severe stomach problems.

In addition, you cannot join if you take most regular prescription drugs (other than stable blood pressure medicine), or if you have severe allergies, regular asthma flare-ups, frequent migraines, or recent substance abuse issues.

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.

  1. Are you between 18 and 65 years old?
  2. Is your BMI between 25 and 45, with a stable weight for the past 3 months?
  3. Do you have normal blood sugar levels and no diagnosis of diabetes?
  4. Are you free from serious liver, pancreas, or gut diseases?
  5. Do you drink 14 units of alcohol or less per week?
  6. Are you able to stay in hospital in London for four separate 3-night visits?
Answer every question to see your result.

What does participation involve?

Taking part begins with a screening visit to check your general health and confirm your eligibility. If suitable, you will attend the Clinical Research Facility at Hammersmith Hospital four separate times. Each visit requires a stay from Monday morning until Thursday afternoon (four days and three nights).

During each hospital stay, you will receive an infusion (a liquid given slowly through a soft plastic tube into a vein in your arm). This will contain either glucagon or a placebo (a dummy liquid with no active medicine). During one of your stays, your meals will also include extra protein.

Throughout your stays, the medical team will take blood samples to measure amino acids, fats, and blood sugar. They will also track your appetite and calculate how much energy your body burns. The whole study runs over several weeks to allow enough time between each visit.

Potential risks and benefits

You will not receive any direct medical benefit from joining this study, but you will receive a thorough health check. The findings will help doctors develop safer, better treatments for obesity and liver health in the future. The most common side effects of glucagon infusions are mild, temporary nausea and vomiting. You may also have minor bruising or tenderness where the drip is inserted into your arm. Taking part is completely voluntary, and you can withdraw at any point without your standard NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • NIHR Imperial Clinical Research Facility
    City only
    London, England

Common questions

Does taking part cost anything?

No. All study-related health checks, meals, and hospital stays are provided free of charge.

Will I lose weight during the study?

The study involves short hospital stays to look at blood markers, so you should not expect noticeable long-term weight loss.

What is a placebo?

A placebo is a harmless dummy treatment that looks just like the real medicine. It helps researchers make a fair comparison.

Where does the trial take place?

All visits take place at the Imperial Clinical Research Facility at Hammersmith Hospital in West London.

Can I leave the study early if I want to?

Yes. You have the right to withdraw at any time, for any reason, and your normal medical care will continue as usual.

How to find out more

Tricia Tan

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

Interested in taking part?

Register your interest

Share your details and the research team for "Investigating the impact of glucagon timing and protein repl…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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