Intermittent Fasting to Improve Insulin Secretion

ConditionsPreDiabetes Diabetes type2 Intermittent Fasting Insulin Secretion

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorUniversity Hospital Tuebingen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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)

Treatment groups

200 Participants

are divided into 4 treatment groups

Group A: Prediabetic subjects - cluster 3Active comparator 2 interventions

Group B: Prediabetic subjects - cluster 5Active comparator 2 interventions

Group C: Patients with type 2 diabetes - subphenotype: Severe insulin-deficient diabetes (SIDD)Active comparator 2 interventions

Group D: Patients with type 2 diabetes - subphenotype: Severe insulin-resistant diabetes (SIRD)Active comparator 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame