RecruitingNAINTERVENTIONAL

Intermittent Fasting to Improve Insulin Secretion

This study is investigating if a special eating pattern called intermittent fasting can improve how the body produces insulin in people with prediabetes or recently diagnosed type 2 diabetes. Currently, many diets for diabetes are hard to stick with long-term, and scientists are looking for new, more effective approaches. We know that problems with insulin production are a big part of type 2 diabetes. This research aims to understand if intermittent fasting can help the body make more insulin, which could potentially slow down or even reverse the progression of the condition. It's the first study to look at this in different types of prediabetes and diabetes, offering new hope for better ways to manage blood sugar.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Tuebingen

Enrolment target

200

Start

08 Apr 2021

Estimated completion

01 Mar 2027

PreDiabetes Diabetes type2 Intermittent Fasting Insulin Secretion

What is this study about?

Type 2 diabetes is a growing health concern worldwide, including in the UK. Many people also have prediabetes, which means their blood sugar levels are higher than normal but not yet high enough to be called diabetes. Both conditions can lead to serious health problems like heart disease and kidney issues over time.

Our bodies use a hormone called insulin to control blood sugar. In type 2 diabetes, either your body doesn't make enough insulin, or the insulin it makes doesn't work as well as it should. Current treatments and diet plans can be hard to follow consistently. This research is exciting because it explores a new idea: whether intermittent fasting, a pattern of eating that cycles between periods of eating and not eating, could help the body produce insulin more effectively. Improving insulin production is seen as a key step in managing and preventing diabetes from getting worse.

Scientists have recently found different types of prediabetes and diabetes that might carry higher risks. This study is the first of its kind to look at how intermittent fasting affects insulin production specifically in these different types, as well as in other people with prediabetes or early type 2 diabetes. By understanding this better, we hope to find new and more effective ways to help people living with or at risk of type 2 diabetes.

Key takeaways

This study explores intermittent fasting for prediabetes and type 2 diabetes.
It aims to see if fasting improves the body's insulin production.
This is a new approach to managing blood sugar that could help many people.
Participation involves following a diet for 4 weeks and having medical checks.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, your body mass index (BMI) should be between 25 and 40. You'll also need to have been diagnosed with prediabetes or type 2 diabetes (diagnosed less than 5 years ago). If you have type 2 diabetes, you shouldn't be using insulin or certain other diabetes medications (thiazolidinediones), and any other diabetes medicines you might be taking would need to be stopped for a short time before starting the study.

There are several reasons why you might not be able to join. For example, if you have type 1 diabetes, are pregnant or breastfeeding, or are taking medications that affect your blood sugar (like steroids or some anti-diabetic drugs). We also can't include people who have certain serious health conditions, such as severe heart, kidney, or liver problems, certain blood disorders, or a history of cancer in the last 5 years.

Other reasons for not being able to join include having a pancreatic disease, serious mental health conditions, certain infections, or special medical devices (like a pacemaker) that would prevent you from having an MRI scan. We also can't include people with certain hearing or temperature sensation 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.

Are you between 18 and 70 years old?
Do you have prediabetes or type 2 diabetes diagnosed less than 5 years ago?
Is your BMI between 25 and 40?
Are you not currently pregnant or breastfeeding?
Do you not have type 1 diabetes or a history of certain severe illnesses?
Are you not currently using insulin or certain specific diabetes medications?

Answer every question to see your result.

What does participation involve?

This study will last for about 4 weeks. You will be asked to follow either an intermittent fasting diet or a control diet. During the study, you will have several appointments at the clinic for assessments. These will include blood tests to check your insulin levels and other markers, as well as potentially an MRI scan to gather more detailed information. The total duration of your involvement, including initial screening and follow-up, will be explained fully if you are interested in taking part.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as gaining a better understanding of how intermittent fasting affects your body's insulin production. This research might also contribute to finding new and better ways to manage or prevent type 2 diabetes for others in the future. However, there could be some risks, including potential side effects from the dietary changes (like hunger or changes in energy levels) or discomfort from blood tests and MRI scans. Your safety and well-being are very important, and you will be closely monitored by medical staff. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason.

Locations (8)

Charité Berlin - Department of Endocrinology and Metabolic Diseases
Verified postcode
Berlin, Germany· Recruiting
Universtiy Hospital Carl Gustav Carus
Verified postcode
Dresden, Germany· Recruiting
German Diabetes Center
Verified postcode
Düsseldorf, Germany· Recruiting
Heidelberg University Hospital - Department of Endocrinology and Metabolism
Verified postcode
Heidelberg, Germany· Recruiting
University Hospital Leipzig - Clinic for Endocrinology and Nephrology
Verified postcode
Leipzig, Germany· Recruiting
University of Luebeck - Institute of Endocrinology and Diabetes
Verified postcode
Lübeck, Germany· Recruiting
Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
Verified postcode
Munich, Germany· Recruiting
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is intermittent fasting?

Intermittent fasting is an eating plan where you switch between periods of eating and not eating on a regular schedule. This study will specify the type of fasting.

What is insulin and why is it important?

Insulin is a hormone made by your body that helps turn the food you eat into energy and keeps your blood sugar levels healthy. In type 2 diabetes, the body doesn't use insulin well or doesn't make enough.

What's the difference between prediabetes and type 2 diabetes?

Prediabetes means your blood sugar is higher than normal but not yet high enough for a diabetes diagnosis. Type 2 diabetes means your blood sugar is consistently too high and requires management.

Will I have to stop my current diabetes medication?

Some diabetes medications might need to be stopped before or during the study, depending on what type they are. This will be discussed with you in detail by the study team.

How long will the study last if I join?

The study intervention itself involves following a diet plan for 4 weeks, with additional time for initial checks and follow-up assessments.

How to find out more

Andreas Fritsche, MD

andreas.fritsche@med.uni-tuebingen.de +49 7071 29 80590 Official trial record

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