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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2021-08-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomised to the intervention or control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Only measurements by assessors will be blinded.

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

Fasting Mimicking diet

Intervention Type OTHER

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.

Control group

Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fasting Mimicking diet

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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No