Actively Recruiting
Intermittent Fasting to Improve Insulin Secretion
Led by University Hospital Tuebingen · Updated on 2026-04-21
200
Participants Needed
8
Research Sites
307 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
G
German Institute of Human Nutrition
Collaborating Sponsor
AI-Summary
What this Trial Is About
Type 2 diabetes (T2D) mellitus is a challenge for health care systems as the numbers increases constantly. In 2014, 422 million people had been living with diabetes worldwide. The absolute numbers of people with prediabetes have also grown substantially over 25 years worldwide. In Germany, about 10% of the population has T2D and another 21 % of the population has prediabetes.Overall, 16% of all deaths in Germany are attributable to type 2 diabetes. Macro- and microvascular complications of diabetes imply a significant threat for the patients and are already present in the prediabetic state. Short term and long term complications, the burden of treatment, and reduced quality of life are major burdens of the disease. Accumulating data indicate that currently recommended therapeutic diet regimens in patients with obesity and diabetes are not sustainable on the long term. Novel concepts are therefore urgently needed. T2D occurs when insulin secretion from pancreatic beta-cells cannot sufficiently be increased to compensate for insulin resistance. Causes of beta-cell dysfunction are heterogeneous. In addition, the most important determinants of diabetes remission are the extend of weight loss and restoration of beta-cell function. In the course of diabetes progression, the inability to recover insulin secretion might identify the state of no return to normal glucose tolerance. It is therefore crucial to improve insulin secretion in treatment and prevention of diabetes. Up to now lifestyle intervention trials in prediabetes or pharmacological intervention trials in diabetes did not show improvement of insulin secretion after intervention. However, one recent small human trial shows that intermittent fasting (early time restricted fasting) is able to improve insulin secretion.Currently, there are no trials that examine the effect of intermittent fasting in individuals with a broad range of impaired glucose metabolism (from prediabetes to diabetes). Recently novel subtypes of diabetes and prediabetes with high risk for the early manifestation of diabetes complications have been identified. Currently, prevention strategies for this high risk individuals have not been examined yet. We will study for the first time the effectiveness of 4 weeks intermittent fasting on changes in insulin secretion capacity in subphenotypes of diabetes and in prediabetes.
CONDITIONS
Official Title
Intermittent Fasting to Improve Insulin Secretion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 25 - 40 kg/m²
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
- Subjects with prediabetes (IFG and/or IGT, HbA1c 5.4% - 6.4%, subphenotype cluster 3 or 5)
- Subjects with type 2 diabetes mellitus diagnosed less than 5 years prior to screening, HbA1c 6.0% - 9.5%, not receiving insulin or thiazolidinediones, with an appropriate washout period for other antidiabetic medications
You will not qualify if you...
- Subjects with type 1 diabetes mellitus (GAD-, IA2-AB positive)
- Women during pregnancy and lactation
- Treatment with any medication affecting glucose metabolism such as anti-diabetic drugs or steroids
- Hemoglobin (Hb) ≤ 11.5 g/dl for males and ≤ 10.5 g/dl for females at screening
- Any pancreatic disease
- Medical history or treatment for cancer within the last 5 years
- Known severe neurological or psychiatric diseases including schizophrenia and bipolar disorder
- History of bariatric surgery
- Severe liver or kidney diseases (ALT or AST above 3 times upper limit of normal or eGFR ≤ 60 ml/min)
- Systemic infection (CRP > 1 mg/dl)
- Severe diabetic complications such as chronic kidney disease, proliferating retinopathy, or symptomatic cardiovascular disease
- Contraindications for MRI such as pacemakers, ferromagnetic clips, metallic splinters in the eye, active electronic devices, or prosthetic heart valves
- Persons with limited temperature sensation or increased sensitivity to body warming
- Persons with hearing disorders or increased sensitivity to loud noises
- Claustrophobia
- Participation in other clinical or competing trials within 30 days prior
- Refusal to be informed of unexpected pathological findings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Charité Berlin - Department of Endocrinology and Metabolic Diseases
Berlin, Germany, 10117
Actively Recruiting
2
Universtiy Hospital Carl Gustav Carus
Dresden, Germany, 01307
Actively Recruiting
3
German Diabetes Center
Düsseldorf, Germany, 40225
Actively Recruiting
4
Heidelberg University Hospital - Department of Endocrinology and Metabolism
Heidelberg, Germany, 69120
Actively Recruiting
5
University Hospital Leipzig - Clinic for Endocrinology and Nephrology
Leipzig, Germany, 04103
Actively Recruiting
6
University of Luebeck - Institute of Endocrinology and Diabetes
Lübeck, Germany, 23538
Actively Recruiting
7
Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
Munich, Germany, 80992
Actively Recruiting
8
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
Tübingen, Germany, 72076
Actively Recruiting
Research Team
A
Andreas Fritsche, MD
CONTACT
M
Michael Roden, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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