Fasting fix? new study tests 4-Week diet to boost insulin in prediabetes and diabetes
NCT ID NCT04607096
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether intermittent fasting can improve how the body releases insulin in people with prediabetes or early type 2 diabetes. About 200 adults with a BMI between 25 and 40 will follow a 4-week fasting plan or a control diet. The goal is to see if fasting can boost the first burst of insulin after eating, which is often impaired in these conditions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Charité Berlin - Department of Endocrinology and Metabolic Diseases
RECRUITINGBerlin, 10117, Germany
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German Diabetes Center
RECRUITINGDüsseldorf, 40225, Germany
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Heidelberg University Hospital - Department of Endocrinology and Metabolism
RECRUITINGHeidelberg, 69120, Germany
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Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
RECRUITINGMunich, 80992, Germany
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University Hospital Leipzig - Clinic for Endocrinology and Nephrology
RECRUITINGLeipzig, 04103, Germany
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University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
RECRUITINGTübingen, 72076, Germany
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University of Luebeck - Institute of Endocrinology and Diabetes
RECRUITINGLübeck, 23538, Germany
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Universtiy Hospital Carl Gustav Carus
RECRUITINGDresden, 01307, Germany
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Other studies related to the condition(s) this trial covers.
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- Can a 9-Hour eating window reset blood sugar and body rhythms?