RecruitingOBSERVATIONAL

Heidelberg Study on Diabetes and Complications

The 'Heidelberg Study on Diabetes and Complications' is an important research project looking into health problems linked to diabetes. It aims to observe how complications develop in people with type 1 diabetes, type 2 diabetes, and even those with 'pre-diabetes'. The study also includes healthy people who don't have diabetes for comparison. Researchers believe that some current ideas about diabetes and its complications might need a fresh look. They want to find new ways to identify who might be at higher risk of developing problems, like issues with kidneys, nerves, or eyes, by exploring different processes in the body. This study doesn't involve any treatments or new medicines; it's purely about understanding and observing.

At a glance

Status

Recruiting

Sponsor

Heidelberg University

Enrolment target

500

Start

01 Sep 2016

Estimated completion

01 Sep 2028

Diabetes Complications

What is this study about?

This study, called the 'Heidelberg Study on Diabetes and Complications,' is all about understanding why some people with diabetes develop serious health problems, often called 'complications.' You might know that diabetes means having high blood sugar, but the researchers in this study think there's more to it than just sugar levels. They are observing people with type 1 diabetes, type 2 diabetes, and even those who are 'pre-diabetic' (meaning their blood sugar levels are higher than normal but not yet at diabetes levels). They are also including people who don't have diabetes at all, to act as a healthy comparison group.

The main aim is to carefully watch these different groups over time to see who develops complications and who doesn't. The researchers want to uncover new reasons or 'risk factors' that might explain why these complications happen. They are particularly interested in certain substances produced by the body during energy creation, which they believe might play a bigger role than previously thought. The study suggests that defining diabetes might be more complex than just focusing on blood sugar levels, and that understanding these 'other factors' could be key to preventing long-term health issues.

It's important to know that this study is observational, which means participants won't be given any new treatments or medicines as part of the study. Instead, researchers will be gathering information to learn more. Their hope is that by understanding these new mechanisms and risk factors, doctors can one day better identify individuals at high risk and develop more effective ways to prevent or manage diabetic complications.

Key takeaways

The study investigates diabetes complications in type 1, type 2, and pre-diabetes.
It aims to find new causes or risk factors for these complications.
Healthy people are also included for comparison.
No new treatments or medications are given; it's purely observational.
Researchers believe complications might be linked to more than just blood sugar levels.

Who may be eligible?

To join this study, you need to be aged between 18 and 75 years old.

They are looking for people who have been diagnosed with either type 1 or type 2 diabetes, based on specific blood test results. They are also including people with 'pre-diabetes,' which means your blood sugar levels are higher than normal but not yet at the level of full diabetes. Finally, healthy people without diabetes or blood sugar issues are also needed for comparison.

There are some reasons why you might not be able to join. For example, if you are currently pregnant, have certain serious heart, kidney, or liver problems, have had cancer recently, or are taking medicines that affect your immune system. You also can't take part if you are currently involved in another study that involves an intervention or a new treatment. There are also specific reasons related to having an MRI scan, such as having a pacemaker or certain metal implants.

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 75 years old?
Do you have type 1, type 2, or pre-diabetes, or are you healthy without diabetes?
Are you currently pregnant?
Do you have severe heart, kidney, or liver problems?
Have you had cancer in the last 5 years?
Do you have a pacemaker or certain metal implants (if MRI is needed)?

Answer every question to see your result.

What does participation involve?

This is an observational study, which means you won't be given any new medications or treatments. The study aims to monitor your health over time. Specific details about the frequency of visits, assessments (like blood tests or scans), and the total duration of your involvement are not provided in this summary. However, observational studies typically involve regular check-ups where researchers collect health information, possibly through questionnaires, physical examinations, and collecting samples like blood or urine. You may also be asked to have an MRI scan, which is a type of scan that uses magnets and radio waves to look inside your body.

Potential risks and benefits

There are generally no direct medical benefits to joining an observational study like this, as it doesn't involve new treatments. However, your participation will greatly help researchers learn more about diabetes and its complications, which could lead to better ways to prevent and treat these conditions in the future, benefiting many others. Possible risks might include the minor discomforts and very small risks associated with blood tests or the time commitment for study visits. If you are asked to have an MRI, there are specific safety checks, and some people with certain medical devices or conditions cannot have them. 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)

Department of Medicine, University of Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What will researchers be looking for in my body?

They'll be looking for signs of diabetes complications and new factors in your body that might contribute to them, beyond just blood sugar levels.

Do I need to take any new medicines for this study?

No, this is an observational study, so you won't be given any new medicines or treatments.

How long will I be involved in the study?

The summary doesn't specify the exact duration, but observational studies often follow participants over a period of time.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time without giving a reason, and it won't affect your medical care.

Will I get results about my own health from the study?

The information provided doesn't specify if individual results will be shared, but generally, observational studies aim to understand groups rather than provide individual diagnoses.

How to find out more

Stefan Kopf, MD

stefan.kopf@med.uni-heidelberg.de +49-6221-56 Official trial record

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