Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT03811587
- Lead Sponsor
- Leiden University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Concentration of HbA1c 12 months Dosage of antidiabetic medication used 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Leiden University Medical Centre
🇳🇱Leiden, Zuid-Holland, Netherlands
Leiden University Medical Centre🇳🇱Leiden, Zuid-Holland, Netherlands