Using intermittent fasting to enhance insulin secretion in diabetes
Intermittent Fasting to Improve Insulin Secretion
This study is testing if intermittent fasting can help people with prediabetes and type 2 diabetes improve their insulin levels and overall health compared to a regular diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 8 sites (Berlin and 7 other locations) |
| Trial ID | NCT04607096 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a body mass index between 25 and 40 kg/m² who have prediabetes or recently diagnosed type 2 diabetes.
Not a fit: Patients with type 1 diabetes, those on medications affecting glucose metabolism, or individuals with severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a sustainable dietary intervention to improve insulin secretion and metabolic health in patients with prediabetes and type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with intermittent fasting in improving metabolic health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Berlin and 7 other locations
- 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)
- Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine — Munich, Germany (Recruiting)
- University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM) — Tübingen, Germany (Recruiting)
Study contacts
- Study coordinator: Andreas Fritsche, MD
- Email: andreas.fritsche@med.uni-tuebingen.de
- Phone: +49 7071 29 80590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.