Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Muscle strength and -mass after bariatric surgery - a possible effect of testosterone replacement therapy? Randomized, placebo-controlled and double-blinded study

This research is investigating whether testosterone replacement therapy can improve muscle strength and size in men. The men taking part are very overweight (have obesity) and also have low testosterone levels, a condition called male hypogonadism. They will have already had or will be having weight-loss surgery. The study will compare a testosterone medicine called Nebido to a dummy treatment (placebo) to see if the testosterone helps build muscle and improve strength. It's a 'double-blind' study, meaning neither the participants nor their doctors will know who is receiving the real medicine and who is getting the placebo. This helps make the results fair and unbiased.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Esbjerg Og Grindsted Sygehus

Enrolment target

Start

20 Sep 2024

Adipositas and male hypogonadism

What is this study about?

This study is designed to understand if giving testosterone replacement therapy to men who are very overweight and also have low testosterone levels can help them regain muscle strength and muscle size. Many men who are very overweight can also have lower testosterone, which can make them feel weak and tired. This study is specifically looking at men who have had or are planning to have weight-loss surgery, as losing a lot of weight quickly can sometimes affect muscle.

The researchers want to see if adding testosterone treatment makes a real difference. They will be comparing the active testosterone medicine (Nebido) with a placebo, which is an inactive substance that looks just like the real medicine. This comparison is very important to make sure any changes seen are truly due to the testosterone and not something else. The study is also 'double-blind,' meaning that neither the patients nor their doctors will know whether they are getting the testosterone or the placebo. This ensures that everyone's expectations don't influence the results.

The main thing the study wants to measure is how strong a person's shoulder muscles become. But they will also look at many other things, like overall body composition (how much fat and muscle someone has), strength in other parts of the body, how well people can perform daily activities like climbing stairs, and even how their body handles sugar. This detailed look will help doctors understand the full picture of how testosterone might help these men.

Key takeaways

This study explores linking testosterone therapy to muscle health in men after weight-loss surgery.
It targets men who are very overweight and also have low testosterone.
Participants will receive either testosterone injections or a dummy injection.
The main goal is to see if testosterone improves muscle strength in the shoulders.
Other measures include body composition, physical function, and metabolism.

Who may be eligible?

To be able to join this study, you need to be a man and at least 18 years old. There's no upper age limit mentioned.

You must also be classed as very overweight, a condition often referred to as obesity. Additionally, it's important that you have a diagnosis of 'male hypogonadism,' which means your body isn't producing enough testosterone.

Since this study relates to weight-loss surgery, you would either need to have already had this surgery or be planning to have it. The research specifically aims to understand the effects of testosterone in men undergoing this type of significant weight loss.

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 a man?
Are you 18 years old or older?
Have you been diagnosed as very overweight (obese)?
Have you been diagnosed with low testosterone (male hypogonadism)?
Have you had or are you planning to have weight-loss surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to either receive the testosterone medicine (Nebido) or a dummy treatment (placebo). Neither you nor your doctor will know which one you're getting. The Nebido medicine is given as an injection, and the placebo will also be an injection that looks similar.

You will have several appointments where doctors will check your progress. They will measure your muscle strength, particularly in your shoulders, and in your arms and legs. They'll also use special scans (like a DXA scan) to see how much muscle and fat you have. You might also be asked to do physical tasks, like climbing stairs, and they will measure how well your body uses oxygen. Blood tests will be taken to check things like your sugar levels and other body functions. The study is considered a Phase IV trial, meaning the medication is already approved for use, but researchers are gathering more information about its effects in this specific group of patients. The total duration of your participation, including follow-up appointments and treatment, would be explained fully by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as improved muscle strength, better overall physical function, and a better understanding of your health, especially if you receive the active testosterone treatment. However, there are also potential risks related to the injections, such as pain or bruising at the injection site, or potential side effects from the testosterone medicine. Any specific risks will be fully explained before you agree to take part. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is 'male hypogonadism'?

This means your body isn't making enough testosterone, a hormone important for men's health, including muscle strength.

What is 'bariatric surgery'?

This is a type of weight-loss surgery for people who are very overweight.

What's a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps compare the effects.

Why is the study 'double-blind'?

Being 'double-blind' means neither you nor the doctors know if you're getting the real medicine or the placebo. This makes the study results more reliable.

How is muscle strength measured?

They will use special equipment to measure the force your muscles can produce, for example, when lifting your arm.