Intermittent Fasting to Improve Insulin Secretion

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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 diabetes mellitus type 2 (diagnosis \< 1 year, HbA1c = 6,5 - 9 %, no medical treatment, subphenotype SIDD or SIRD)

Locations
Other Locations
Germany
Charité Berlin - Department of Endocrinology and Metabolic Diseases
NOT_YET_RECRUITING
Berlin
Universtiy Hospital Carl Gustav Carus
NOT_YET_RECRUITING
Dresden
German Diabetes Center
NOT_YET_RECRUITING
Düsseldorf
Heidelberg University Hospital - Department of Endocrinology and Metabolism
NOT_YET_RECRUITING
Heidelberg
University Hospital Leipzig - Clinic for Endocrinology and Nephrology
NOT_YET_RECRUITING
Leipzig
University of Luebeck - Institute of Endocrinology and Diabetes
NOT_YET_RECRUITING
Lübeck
Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
NOT_YET_RECRUITING
Munich
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
RECRUITING
Tübingen
Contact Information
Primary
Andreas Fritsche, MD
andreas.fritsche@med.uni-tuebingen.de
+49 7071 29 80590
Backup
Michael Roden, MD
michael.roden@ddz.de
+49 211 3382 201
Time Frame
Start Date: 2021-04-08
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 200
Treatments
Active_comparator: 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).
Active_comparator: 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).
Active_comparator: 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).
Active_comparator: 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).
Related Therapeutic Areas
Sponsors
Collaborators: Ludwig-Maximilians - University of Munich, University Hospital Carl Gustav Carus, German Institute of Human Nutrition, University of Leipzig, Charite University, Berlin, Germany, German Diabetes-Center, Leibniz-Institut in Düsseldorf, University of Luebeck, German Center for Diabetes Research, University Hospital Heidelberg
Leads: University Hospital Tuebingen

This content was sourced from clinicaltrials.gov