RecruitingNAINTERVENTIONAL

Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness

This study aims to understand how a medicine called semaglutide, which is similar to a natural hormone (GLP-1), affects the brain’s response to insulin. Researchers are looking at people with normal weight, overweight, and obesity. Participants will receive either semaglutide or a dummy drug, followed by a special brain scan (fMRI) while receiving insulin or a dummy spray through the nose. The main goal is to see if semaglutide changes how the brain reacts to insulin, specifically looking at blood flow and activity in different brain areas. The study also explores how these changes might affect thinking skills and eating behaviour. This research helps us understand the link between GLP-1, brain function, and managing weight.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Tuebingen

Enrolment target

Start

01 Jul 2024

Estimated completion

31 Dec 2027

Normal Weight Overweight and Obesity Insulin Sensitivity Insulin Resistance

What is this study about?

You might have heard of GLP-1 because it's a natural substance in your body that helps control blood sugar and appetite. Some medicines are designed to act like GLP-1. This study wants to find out if one of these medicines, called semaglutide, changes how your brain responds to insulin. Insulin is a hormone that helps your body use sugar for energy, and it also plays a role in your brain.

To do this, volunteers will be given either semaglutide or a dummy drug. Later, they'll have a special type of brain scan called an fMRI. During this scan, they'll also receive either insulin or a dummy spray through their nose. The researchers will be carefully watching how different parts of the brain react. They're particularly interested in how blood flows in the brain and how active different brain areas are when insulin is given.

Beyond brain scans, the study will also look at how thinking abilities and eating behaviours are affected. By understanding how semaglutide influences the brain's response to insulin, we could learn more about how to help people with their weight and overall health. This research is important because it could lead to new ways of thinking about how our brains, insulin, and weight are connected.

Key takeaways

This study explores how a GLP-1 type medicine affects your brain's response to insulin.
It uses special brain scans (fMRI) with nasal insulin or a dummy spray.
The research aims to understand connections between GLP-1, brain function, and weight.
Participants can be of normal weight, overweight, or have obesity, aged 18-70.
You won't know if you're getting the active drug or a placebo during the study.

Who may be eligible?

This study is looking for both men and women between the ages of 18 and 70. You could be considered if you have a healthy weight (BMI between 18.5 and 24.9) or if you are overweight or have obesity (BMI between 27.5 and 40). You must be willing to give written permission to take part and to be told about any unexpected health findings.

However, there are some reasons why you wouldn't be able to join. For example, if you have type 1 or type 2 diabetes, certain heart conditions, or a history of serious mental or physical health problems. If you are pregnant or breastfeeding, or if you are taking medications that affect your mood or blood sugar, you also wouldn't be able to participate. They can't include you if you have certain metal implants, severe claustrophobia, or if you've had major surgery recently.

It's important that you haven't been in another research study involving lifestyle changes or medicines in the last month. The researchers also need to make sure you don’t have any other health issues, including certain thyroid conditions or previous cancers, that might affect the study or put you at risk.

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?
Is your BMI between 18.5 and 24.9, or between 27.5 and 40?
Do you have type 1 or type 2 diabetes, or serious heart problems?
Are you pregnant or breastfeeding, or could you become pregnant?
Do you have any metal implants that cannot be removed?
Have you recently participated in another research study involving drugs or lifestyle changes within the last 30 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for a specific period. You’ll be assigned to either receive semaglutide (the active drug) or a placebo (a dummy drug) at different times during the study – this is to help researchers compare the effects accurately. You will have several study visits where you will receive your medication.

Key parts of your involvement will include undergoing special brain scans called fMRI (functional Magnetic Resonance Imaging). During these scans, you will receive a small amount of insulin or a placebo through a nasal spray. You will also participate in tasks that test your thinking skills and report on your eating behaviours. The total number of visits and the exact duration of your participation will be explained in detail by the study team, but typically these kinds of studies involve multiple appointments over several days or weeks.

Potential risks and benefits

Taking part in any study has potential benefits and risks. While this study may not directly improve your health, it could provide valuable information that helps many people in the future. Potential risks might include mild side effects from the study medication or nasal spray, discomfort during the fMRI scan (such as lying still in an enclosed space), or the time commitment required. All procedures will be fully explained, and staff will be on hand to answer any questions. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Clinic Tubingen, Department of Internal Medicine IV
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is GLP-1 and semaglutide?

GLP-1 is a natural hormone in your body that helps control blood sugar and appetite. Semaglutide is a medicine that acts like this natural hormone.

What is an fMRI scan?

An fMRI is a special type of brain scan that shows which parts of your brain are active. It uses powerful magnets, not radiation, and usually involves lying very still inside a scanner.

Will I know if I'm getting the real drug or a dummy drug?

No, this is a 'single-blinded' study, meaning you won't know if you're receiving semaglutide or the dummy drug (placebo) at any given time. This helps ensure fair results.

Will I get insulin through my nose?

Yes, during some brain scans, you will receive either a small dose of insulin or a dummy spray through your nose. This helps researchers see how your brain reacts.

Do I need to change my diet?

The study does include assessments of eating behaviour, but you should discuss any specific dietary instructions or requirements directly with the study team.

How to find out more

Stephanie Kullmann, PhD

stephanie.kullmann@med.uni-tuebingen.de 0049707129 Official trial record

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