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Intermittent Fasting to Improve Insulin Secretion

RecruitingNAAges 18 Years - 70 YearsAllUniversity Hospital Tuebingen
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) or * Subjects with type 2 diabetes mellitus (diagnosed \<5 years prior to screening), HbA1c 6.0% - 9.5%, not receiving insulin or thiazolidinediones, and with an appropriate washout period for all other antidiabetic medications) Exclusion Criteria: * Subjects with diabetes mellitus type 1 (GAD-, IA2-AB positive) * Women during pregnancy and lactation * Treamtent with any medication effecting on glucose metabolism like anti-diabetic drugs or steroids * Subjects with a haemoglobin (Hb) ≤ 11.5 g/dl (for males) and Hb ≤ 10.5 g/dl (for females) at screening * Any pancreatic disease * Medical history of cancer and/or treatment for cancer within the last 5 years. * Known current presence or history of severe neurological or psychiatric diseases, schizophrenia, bipolar disorder * Known history of bariatric surgery * Severe liver or kidney diseases (Alanine Aminotransferase (ALT \[SGPT\]), Aspartate Aminotransferase (AST \[SGOT\]) above 3 x upper limit of normal (ULN) or Glomerular Filtration Rate (eGFR) ≤ 60 ml/min (MDRD formula) * Systemic infection (CRP \> 1 mg/dl) * Severe diabetic complications like chronic kidney disease (CKD), proliferating retinopathy or symptomatic cardiovascular disease * Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc. * Persons with limited temperature sensation and / or elevated sensitivity to warming of the body * Persons with a hearing disorder or a increased sensitivity for loud noises * Claustrophobia * Participation in other clinical trials or observation period of competing trials up to 30 days prior to this study * Refusal to get informed of unexpected detected pathological findings
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What it tests

  • Intermittent fasting
  • Control diet
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Where

8 sites
Charité Berlin - Department of Endocrinology and Metabolic Diseases
Berlin, Germany
Universtiy Hospital Carl Gustav Carus
Dresden, Germany
German Diabetes Center
Düsseldorf, Germany
Heidelberg University Hospital - Department of Endocrinology and Metabolism
Heidelberg, Germany
University Hospital Leipzig - Clinic for Endocrinology and Nephrology
Leipzig, Germany
University of Luebeck - Institute of Endocrinology and Diabetes
Lübeck, Germany
Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
Munich, Germany
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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