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NCT Number: NCT04607096

Intermittent Fasting to Improve Insulin Secretion

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.

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Key information

Conditions

PreDiabetes Behavior Diabetes Mellitus Diabetes type2 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Insulin Secretion Intermittent Fasting Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Berlin - Department of Endocrinology and Metabolic Diseases, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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 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

Treatment and study plan

Intermittent fasting

Behavioral

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

Behavioral

Control group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in second 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 second phase insulin secretion adjusted for insulin sensitivity during an hyperglycemic clamp.

  2. Change in insulin sensitivity.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effect of intermittent fasting vs. a control diet on insulin sensitivity using insulin sensitivity index during an hyperglycemic clamp.

  3. Change in BMI.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effect of intermittent vs. a control diet fasting on BMI.

  4. Change in liver fat content.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effects of intermittent fasting vs. a control diet on liver fat content (%) measured by magnetic resonance spectroscopy (3 T whole body imaging).

  5. Change in pancreatic fat content.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effects of intermittent fasting on pancreatic fat content (%) measured by magnetic resonance spectroscopy (3 T whole body imaging).

  6. Change in body fat content.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effects of intermittent fasting vs. a control diet on total adipose tissue (TAT) measured by magnetic resonance tomography (3 T whole body imaging).

  7. Change in visceral adipose tissue.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effects of intermittent fasting vs. a control diet on visceral adipose tissue (VAT) measured by by magnetic resonance tomography (3 T whole body imaging)

  8. Change in subcutaneous adipose tissue.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effects of intermittent fasting vs. a control diet on subcutaneous adipose tissue (SCAT) measured by by magnetic resonance tomography (3 T whole body imaging)

Other outcomes

  1. Change in brain insulin sensitivity.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effects of intermittent fasting vs. a control diet on brain insulin sensitivity measured by functional magnetic resonance imaging (fMRI) combined with nasal insulin administration.

  2. Change in resting energy expenditure (REE).

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effects of intermittent fasting vs. a control diet on resting energy expenditure measured by indirect calorimetry.

  3. Change in substrate oxidation.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effects of intermittent fasting vs. a control diet on substrate oxidation measured by indirect calorimetry.

  4. Change in proinsulin processing.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effect of intermittent fasting vs. a control diet on first phase proinsulin processing during an hyperglycemic clamp.

  5. Change in glucagon suppression.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effect of intermittent fasting vs. a control diet on glucagon suppression during an hyperglycemic clamp.

  6. Change in insuin clearance.

    Time frame: Before, after 4 weeks and after 24 weeks of lifestyle intervention.

    Effect of intermittent fasting vs. a control diet on insulin clearance during an hyperglycemic clamp.

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Fritsche, MD

CONTACT

[email protected]

+49 7071 29 80590

Michael Roden, MD

CONTACT

[email protected]

+49 211 3382 201

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Charite University, Berlin, Germany
  • German Center for Diabetes Research
  • German Diabetes-Center, Leibniz-Institut in Düsseldorf
  • German Institute of Human Nutrition
  • Ludwig-Maximilians - University of Munich
  • University Hospital Carl Gustav Carus
  • University Hospital Heidelberg
  • University of Leipzig
  • University of Luebeck

Registry information

Acronym: IFIS

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 28, 2020
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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