PreDiabetesIFISNCT04607096
Intermittent Fasting to Improve Insulin Secretion
A study testing Intermittent fasting in people with PreDiabetes and Diabetes type2, run by University Hospital Tuebingen at 8 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PreDiabetes, Diabetes type2, Intermittent Fasting
- What is being tested?
- Intermittent fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesGermany
- Study dates
- 8 Apr 2021to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Germany8 sites, 8 recruiting
- Recruiting
Charité Berlin - Department of Endocrinology and Metabolic Diseases
Berlin, 10117
Joachim Spranger, MD, +49 30 450 514 252, joachim.spranger@charite.de
- Recruiting
Universtiy Hospital Carl Gustav Carus
Dresden, 01307
Peter Schwarz, MD, +49 (0) 351 458271, peter.schwarz@uniklinikum-dresden.de
- Recruiting
German Diabetes Center
Düsseldorf, 40225
Michael Roden, MD, +49 211 3382 201, michael.roden@ddz.de
- Recruiting
Heidelberg University Hospital - Department of Endocrinology and Metabolism
Heidelberg, 69120
Julia Szendrödi, MD, +49 (0) 6221 56-8601, Julia.Szendrödi@med.uni-heidelberg.de
- Recruiting
University Hospital Leipzig - Clinic for Endocrinology and Nephrology
Leipzig, 04103
Matthias Blüher, MD, +49 (0)341 - 97 13320, Matthias.blüher@medizin.uni-leipzig.de
- Recruiting
University of Luebeck - Institute of Endocrinology and Diabetes
Lübeck, 23538
Svenja Meyhöfer, MD, svenja.meyhoefer@uni-luebeck.de
- Recruiting
Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
Munich, 80992
Hans Hauner, MD, +49 (0) 8928924911, hans.hauner@tum.de
- Recruiting
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
Tübingen, 72076
Andreas Fritsche, MD, +49 7071 29 80590, andreas.fritsche@med.uni-tuebingen.de
About this study
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 therefore urgently needed.
T2D occurs when insulin secretion from pancreatic beta-cells cannot sufficiently be increased to compensate for insulin resistance. Causes of beta-cell dysfunction are heterogeneous. In addition, the most important determinants of diabetes remission are the extend of weight loss and restoration of beta-cell function. In the course of diabetes progression, the inability to recover insulin secretion might identify the state of no return to normal glucose tolerance. It is therefore crucial to improve insulin secretion in treatment and prevention of diabetes. Up to now lifestyle intervention trials in prediabetes or pharmacological intervention trials in diabetes did not show improvement of insulin secretion after intervention. However, one recent small human trial shows that intermittent fasting (early time restricted fasting) is able to improve insulin secretion.Currently, there are no trials that examine the effect of intermittent fasting in individuals with a broad range of impaired glucose metabolism (from prediabetes to diabetes). Recently novel subtypes of diabetes and prediabetes with high risk for the early manifestation of diabetes complications have been identified. Currently, prevention strategies for this high risk individuals have not been examined yet. We will study for the first time the effectiveness of 4 weeks intermittent fasting on changes in insulin secretion capacity in subphenotypes of diabetes and in prediabetes.
- Conditions
- PreDiabetes, Diabetes type2, Intermittent Fasting, Insulin Secretion
- Being tested
- Intermittent fasting, Control diet
- Medical subject headings
- Prediabetic State, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastingBehavioural
The intermittent fasting intervention consists of a decreased daily caloric intake of 400 kcal below individual requirements (Harris Benedict Formula) combined with early time restricted fasting according to the schema 16:8. fasting will be performed over 4 weeks.
Control dietBehavioural
Control group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula)
| Study group | Role | What they receive |
|---|---|---|
| Prediabetic subjects - cluster 3 | Active comparator | Presence of a cluster 3 phenotype will be examined according to the parameters described by Wagner et al.(Nat. Med. 2020). Receives: Behavioral: Intermittent fasting; Behavioral: Control diet |
| Prediabetic subjects - cluster 5 | Active comparator | Presence of a cluster 5 phenotype will be examined according to the parameters described by Wagner et al.(Nat. Med. 2020). Receives: Behavioral: Intermittent fasting; Behavioral: Control diet |
| Patients with type 2 diabetes - subphenotype: Severe insulin-deficient diabetes (SIDD) | Active comparator | Presence of a SIDD phenotype will be examined according to the parameters de-scribed Ahlqvist et al. (Lancet Diabetes Endocrinol. 2018 May;6(5):361-369). Receives: Behavioral: Intermittent fasting; Behavioral: Control diet |
| Patients with type 2 diabetes - subphenotype: Severe insulin-resistant diabetes (SIRD) | Active comparator | Presence of a SIRD phenotype will be examined according to the parameters de-scribed Ahlqvist et al (Lancet Diabetes Endocrinol. 2018 May;6(5):361-369). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in first phase insulin secretion.
Effect of intermittent fasting vs. a control diet on glucose stimulated first phase insulin secretion adjusted for insulin sensitivity during an hyperglycemic clamp.
Measured: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Secondary outcomes (8)
Change in second phase insulin secretion.
Effect of intermittent fasting vs. a control diet on glucose stimulated second phase insulin secretion adjusted for insulin sensitivity during an hyperglycemic clamp.
Measured: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in insulin sensitivity.
Effect of intermittent fasting vs. a control diet on insulin sensitivity using insulin sensitivity index during an hyperglycemic clamp.
Measured: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in BMI.
Effect of intermittent vs. a control diet fasting on BMI.
Measured: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in liver fat content.
Effects of intermittent fasting vs. a control diet on liver fat content (%) measured by magnetic resonance spectroscopy (3 T whole body imaging).
Measured: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in pancreatic fat content.
Effects of intermittent fasting on pancreatic fat content (%) measured by magnetic resonance spectroscopy (3 T whole body imaging).
Measured: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in body fat content.
Effects of intermittent fasting vs. a control diet on total adipose tissue (TAT) measured by magnetic resonance tomography (3 T whole body imaging).
Measured: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in visceral adipose tissue.
Effects of intermittent fasting vs. a control diet on visceral adipose tissue (VAT) measured by by magnetic resonance tomography (3 T whole body imaging)
Measured: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in subcutaneous adipose tissue.
Effects of intermittent fasting vs. a control diet on subcutaneous adipose tissue (SCAT) measured by by magnetic resonance tomography (3 T whole body imaging)
Measured: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start8 Apr 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants wil either receive a control diet or join the intermittent fasting group stratified by glycemia (prediabetes/diabetes) as well as by subphenotype.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Institute of Human Nutrition, Charite University, Berlin, Germany, University Hospital Carl Gustav Carus, University of Leipzig, Ludwig-Maximilians - University of Munich, University Hospital Heidelberg, University of Luebeck, German Diabetes-Center, Leibniz-Institut in Düsseldorf, German Center for Diabetes Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607096
- Sponsor's protocol ID
- 596/2020BO1
- Acronym
- IFIS
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2020
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heilmann G, Trenkamp S, Moser C, Bombrich M, Schon M, Yurchenko I, Strassburger K, Rodriguez MM, Zaharia OP, Burkart V, Wagner R, Roden M. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes. Clin Chem Lab Med. 2023 Oct 24;62(4):762-769. doi: 10.1515/cclm-2023-0770. Print 2024 Mar 25.
PubMed 37870928
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Fasting to Improve Insulin Secretion
- ClinicalTrials.gov ID
- NCT04607096
- Acronym / sponsor ID
- IFIS / 596/2020BO1
- Conditions
- PreDiabetes, Diabetes type2, Intermittent Fasting, Insulin Secretion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Institute of Human Nutrition, Charite University, Berlin, Germany, University Hospital Carl Gustav Carus, University of Leipzig, Ludwig-Maximilians - University of Munich, University Hospital Heidelberg, University of Luebeck, German Diabetes-Center, Leibniz-Institut in Düsseldorf, German Center for Diabetes Research
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 therefore urgently needed.
T2D occurs when insulin secretion from pancreatic beta-cells cannot sufficiently be increased to compensate for insulin resistance. Causes of beta-cell dysfunction are heterogeneous. In addition, the most important determinants of diabetes remission are the extend of weight loss and restoration of beta-cell function. In the course of diabetes progression, the inability to recover insulin secretion might identify the state of no return to normal glucose tolerance. It is therefore crucial to improve insulin secretion in treatment and prevention of diabetes. Up to now lifestyle intervention trials in prediabetes or pharmacological intervention trials in diabetes did not show improvement of insulin secretion after intervention. However, one recent small human trial shows that intermittent fasting (early time restricted fasting) is able to improve insulin secretion.Currently, there are no trials that examine the effect of intermittent fasting in individuals with a broad range of impaired glucose metabolism (from prediabetes to diabetes). Recently novel subtypes of diabetes and prediabetes with high risk for the early manifestation of diabetes complications have been identified. Currently, prevention strategies for this high risk individuals have not been examined yet. We will study for the first time the effectiveness of 4 weeks intermittent fasting on changes in insulin secretion capacity in subphenotypes of diabetes and in prediabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants wil either receive a control diet or join the intermittent fasting group stratified by glycemia (prediabetes/diabetes) as well as by subphenotype.
| Arm | Type | Receives |
|---|---|---|
| Prediabetic subjects - cluster 3 | Active comparator | Behavioral: Intermittent fasting, Behavioral: Control dietPresence of a cluster 3 phenotype will be examined according to the parameters described by Wagner et al.(Nat. Med. 2020). |
| Prediabetic subjects - cluster 5 | Active comparator | Behavioral: Intermittent fasting, Behavioral: Control dietPresence of a cluster 5 phenotype will be examined according to the parameters described by Wagner et al.(Nat. Med. 2020). |
| Patients with type 2 diabetes - subphenotype: Severe insulin-deficient diabetes (SIDD) | Active comparator | Behavioral: Intermittent fasting, Behavioral: Control dietPresence of a SIDD phenotype will be examined according to the parameters de-scribed Ahlqvist et al. (Lancet Diabetes Endocrinol. 2018 May;6(5):361-369). |
| Patients with type 2 diabetes - subphenotype: Severe insulin-resistant diabetes (SIRD) | Active comparator | –Presence of a SIRD phenotype will be examined according to the parameters de-scribed Ahlqvist et al (Lancet Diabetes Endocrinol. 2018 May;6(5):361-369). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent fastingThe intermittent fasting intervention consists of a decreased daily caloric intake of 400 kcal below individual requirements (Harris Benedict Formula) combined with early time restricted fasting according to the schema 16:8. fasting will be performed over 4 weeks. | Behavioural | Patients with type 2 diabetes - subphenotype: Severe insulin-deficient diabetes (SIDD), Prediabetic subjects - cluster 3, Prediabetic subjects - cluster 5 |
| Control dietControl group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula) | Behavioural | Patients with type 2 diabetes - subphenotype: Severe insulin-deficient diabetes (SIDD), Prediabetic subjects - cluster 3, Prediabetic subjects - cluster 5 |
Primary outcome
Change in first phase insulin secretion.
Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Effect of intermittent fasting vs. a control diet on glucose stimulated first phase insulin secretion adjusted for insulin sensitivity during an hyperglycemic clamp.
8 secondary outcomes
Change in second phase insulin secretion.
Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in insulin sensitivity.
Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in BMI.
Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in liver fat content.
Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in pancreatic fat content.
Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in body fat content.
Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in visceral adipose tissue.
Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in subcutaneous adipose tissue.
Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 37870928Heilmann G, Trenkamp S, Moser C, Bombrich M, Schon M, Yurchenko I, Strassburger K, Rodriguez MM, Zaharia OP, Burkart V, Wagner R, Roden M. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes. Clin Chem Lab Med. 2023 Oct 24;62(4):762-769. doi: 10.1515/cclm-2023-0770. Print 2024 Mar 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent fasting in people with PreDiabetes and Diabetes type2, run by University Hospital Tuebingen at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Fritsche, MD (+49 7071 29 80590, andreas.fritsche@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in first phase insulin secretion. (time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.