Intermittent Fasting to Improve Insulin Secretion
IFIS
1 other identifier
interventional
200
1 country
8
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedStudy Start
First participant enrolled
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 21, 2026
April 1, 2026
5.7 years
October 22, 2020
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Secondary Outcomes (8)
Change in second phase insulin secretion.
Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in insulin sensitivity.
Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in BMI.
Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in liver fat content.
Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in pancreatic fat content.
Before, after 4 weeks and after 24 weeks of lifestyle intervention.
- +3 more secondary outcomes
Other Outcomes (6)
Change in brain insulin sensitivity.
Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in resting energy expenditure (REE).
Before, after 4 weeks and after 24 weeks of lifestyle intervention.
Change in substrate oxidation.
Before, after 4 weeks and after 24 weeks of lifestyle intervention.
- +3 more other outcomes
Study Arms (4)
Prediabetic subjects - cluster 3
ACTIVE COMPARATORPresence 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 COMPARATORPresence 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 COMPARATORPresence 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 COMPARATORPresence 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).
Interventions
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 group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Carl Gustav Caruscollaborator
- University of Leipzigcollaborator
- Ludwig-Maximilians - University of Munichcollaborator
- University Hospital Heidelbergcollaborator
- University of Luebeckcollaborator
- University Hospital Tuebingenlead
- German Institute of Human Nutritioncollaborator
- Charite University, Berlin, Germanycollaborator
- German Diabetes-Center, Leibniz-Institut in Düsseldorfcollaborator
- German Center for Diabetes Researchcollaborator
Study Sites (8)
Charité Berlin - Department of Endocrinology and Metabolic Diseases
Berlin, 10117, Germany
Universtiy Hospital Carl Gustav Carus
Dresden, 01307, Germany
German Diabetes Center
Düsseldorf, 40225, Germany
Heidelberg University Hospital - Department of Endocrinology and Metabolism
Heidelberg, 69120, Germany
University Hospital Leipzig - Clinic for Endocrinology and Nephrology
Leipzig, 04103, Germany
University of Luebeck - Institute of Endocrinology and Diabetes
Lübeck, 23538, Germany
Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
Munich, 80992, Germany
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
Tübingen, 72076, Germany
Related Publications (1)
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.
PMID: 37870928DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2020
First Posted
October 28, 2020
Study Start
April 8, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share