Intermittent Fasting to Improve Insulin Secretion

Last updated: May 8, 2024
Sponsor: University Hospital Tuebingen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

Control diet

Intermittent fasting

Clinical Study ID

NCT04607096
596/2020BO1
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) between 25 - 40 kg/m²
  • Understand and voluntarily sign an informed consent document prior to any studyrelated assessments/procedures.
  • Subjects with prediabetes (IFG and/or IGT, HbA1c 5,4 % - 6,4 %, subphenotype cluster 3or 5) or
  • Subjects with diabetes mellitus type 2 (diagnosis < 1 year, HbA1c = 6,5 - 9 %, nomedical treatment, subphenotype SIDD or SIRD)

Exclusion

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 drugsor steroids
  • Subjects with a haemoglobin (Hb) ≤ 11.5 g/dl (for males) and Hb ≤ 10.5 g/dl (forfemales) 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]), AspartateAminotransferase (AST [SGOT]) above 3 x upper limit of normal (ULN) or GlomerularFiltration Rate (eGFR) ≤ 60 ml/min (MDRD formula)
  • Systemic infection (CRP > 1 mg/dl)
  • Severe diabetic complications like chronic kidney disease (CKD), proliferatingretinopathy or symptomatic cardiovascular disease
  • Presence of any contraindication for the conduct of an MRI investigation, such ascardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system,metallic splinters in the eye, ferromagnetic or electronically operated active deviceslike automatic cardioverter defibrillators, cochlear implants, insulin pumps and nervestimulators, prosthetic heart valves etc.
  • Persons with limited temperature sensation and / or elevated sensitivity to warming ofthe 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

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Control diet
Phase:
Study Start date:
April 08, 2021
Estimated Completion Date:
March 01, 2025

Connect with a study center

  • Charité Berlin - Department of Endocrinology and Metabolic Diseases

    Berlin, 10117
    Germany

    Site Not Available

  • Universtiy Hospital Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • German Diabetes Center

    Duesseldorf, 40225
    Germany

    Site Not Available

  • Heidelberg University Hospital - Department of Endocrinology and Metabolism

    Heidelberg, 69120
    Germany

    Site Not Available

  • University Hospital Leipzig - Clinic for Endocrinology and Nephrology

    Leipzig, 04103
    Germany

    Site Not Available

  • University of Luebeck - Institute of Endocrinology and Diabetes

    Luebeck, 23538
    Germany

    Site Not Available

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

    Munich, 80992
    Germany

    Site Not Available

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

    Tuebingen, 72076
    Germany

    Active - Recruiting

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