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Fasting fix? new study tests 4-Week diet to boost insulin in prediabetes and diabetes

NCT ID NCT04607096

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Charité Berlin - Department of Endocrinology and Metabolic Diseases

    RECRUITING

    Berlin, 10117, Germany

  • German Diabetes Center

    RECRUITING

    Düsseldorf, 40225, Germany

  • Heidelberg University Hospital - Department of Endocrinology and Metabolism

    RECRUITING

    Heidelberg, 69120, Germany

  • Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine

    RECRUITING

    Munich, 80992, Germany

  • University Hospital Leipzig - Clinic for Endocrinology and Nephrology

    RECRUITING

    Leipzig, 04103, Germany

  • University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)

    RECRUITING

    Tübingen, 72076, Germany

  • University of Luebeck - Institute of Endocrinology and Diabetes

    RECRUITING

    Lübeck, 23538, Germany

  • Universtiy Hospital Carl Gustav Carus

    RECRUITING

    Dresden, 01307, Germany

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