Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
In this randomized, controlled, assessor blinded and prospective intervention study the investigators will evaluate the clinical feasibility and effectiveness of intermittent use of a fasting mimicking diet in patients with type 2 diabetes mellitus compared to usual care.

Detailed Description
-----------------
100 individuals (men or women, ethnicity not specified) with type 2 diabetes and a BMI≥ 27, who are treated with diet only and have a HbA1c > 48, or who are treated with diet and a dose of metformin can participate in the study. Participants will use a fasting-mimicking diet for 5 consecutive days per month. For the other days, there are no regulations. During follow-up of one year, several study parameters will be measured including HbA1c and antidiabetic medication dosage.

Official Title
-----------------
Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Fasting Mimicking diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes Age > 17 years and <75 years Treatment with diet only and have a HbA1c > 48, or treatment with diet and metformin BMI ≥ 27 Exclusion Criteria: Recent myocardial infarction (< 6 months) Creatinine clearance < 30 ml/min/1,73m2 (MDRD) Pregnancy Contraindications for MRI Allergy for nuts, sesame, soya or another ingredient of the diet History of syncope with calorie restriction in the past Any significant other disease (at the discretion of the investigator)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomised to the intervention or control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Diabetes type 2 patients will take a fasting mimicking diet of 5 consecutive days a month, for a duration of 12 months. Besides this, they will receive usual diabetes care from the general practitioner. | Other: Fasting Mimicking diet<br>* The fasting mimicking diet is though to activate the metabolism as fasting would do, although the diet does include several meals a day and more calories than conventional fasting diets.<br>|
| No Intervention: Control group<br>Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of HbA1c |  | 12 months | 
| Dosage of antidiabetic medication used |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, Fasting