Using intermittent fasting to enhance insulin secretion in diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of intermittent fasting on insulin secretion in individuals with prediabetes and type 2 diabetes. The study aims to determine whether this dietary approach can improve metabolic health and insulin sensitivity compared to a control diet. Participants will be selected based on specific criteria, including body mass index and diabetes status, and will undergo assessments to evaluate the impact of intermittent fasting on their condition. The trial is conducted across multiple prominent institutions in Germany.

Why it matters

Who can join: the full rules

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

Where it's running

• Charité Berlin - Department of Endocrinology and Metabolic Diseases
  Berlin, Germany Recruiting
• Universtiy Hospital Carl Gustav Carus
  Dresden, Germany Recruiting
• German Diabetes Center
  Düsseldorf, Germany Recruiting
• Heidelberg University Hospital - Department of Endocrinology and Metabolism
  Heidelberg, Germany Recruiting
• University Hospital Leipzig - Clinic for Endocrinology and Nephrology
  Leipzig, Germany Recruiting
• University of Luebeck - Institute of Endocrinology and Diabetes
  Lübeck, Germany Recruiting

Study contacts

• Study coordinator: Andreas Fritsche, MD
• Email: andreas.fritsche@med.uni-tuebingen.de
• Phone: +49 7071 29 80590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.