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

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Fasting Mimicking diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03811587

NL63892.058.18 - P18.049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Treatment group

Experimental group

Description:

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.

Treatment:

Other: Fasting Mimicking diet

Control group

No Intervention group

Description:

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