Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-04-08
2025-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prediabetic subjects - cluster 3
Presence of a cluster 3 phenotype will be examined according to the parameters described by Wagner et al.(Nat. Med. 2020).
Intermittent fasting
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 diet
Control group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula)
Prediabetic subjects - cluster 5
Presence of a cluster 5 phenotype will be examined according to the parameters described by Wagner et al.(Nat. Med. 2020).
Intermittent fasting
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 diet
Control group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula)
Patients with type 2 diabetes - subphenotype: Severe insulin-deficient diabetes (SIDD)
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).
Intermittent fasting
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 diet
Control group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula)
Patients with type 2 diabetes - subphenotype: Severe insulin-resistant diabetes (SIRD)
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).
Intermittent fasting
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 diet
Control group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula)
Interventions
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Intermittent fasting
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 diet
Control group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula)
Eligibility Criteria
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Inclusion Criteria
* 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 diabetes mellitus type 2 (diagnosis \< 1 year, HbA1c = 6,5 - 9 %, no medical treatment, subphenotype SIDD or SIRD)
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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German Institute of Human Nutrition
OTHER
Charite University, Berlin, Germany
OTHER
University Hospital Carl Gustav Carus
OTHER
University of Leipzig
OTHER
Ludwig-Maximilians - University of Munich
OTHER
University Hospital Heidelberg
OTHER
University of Luebeck
OTHER
German Diabetes-Center, Leibniz-Institut in Düsseldorf
OTHER
German Center for Diabetes Research
OTHER
University Hospital Tuebingen
OTHER
Responsible Party
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Locations
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Charité Berlin - Department of Endocrinology and Metabolic Diseases
Berlin, , Germany
Universtiy Hospital Carl Gustav Carus
Dresden, , Germany
German Diabetes Center
Düsseldorf, , Germany
Heidelberg University Hospital - Department of Endocrinology and Metabolism
Heidelberg, , Germany
University Hospital Leipzig - Clinic for Endocrinology and Nephrology
Leipzig, , Germany
University of Luebeck - Institute of Endocrinology and Diabetes
Lübeck, , Germany
Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
Munich, , Germany
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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596/2020BO1
Identifier Type: -
Identifier Source: org_study_id
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