Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Leiden University Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Concentration of HbA1c
- Status
- Completed
- Last Updated
- 4 years ago
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.
Investigators
Hanno Pijl
Clinical Professor
Leiden University Medical Center
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
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)
Outcomes
Primary Outcomes
Concentration of HbA1c
Time Frame: 12 months
Dosage of antidiabetic medication used
Time Frame: 12 months