Status:
COMPLETED
Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Dutch Diabetes Research Foundation
Health Holland
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-74 years
Phase:
NA
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 mimickin...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03811587
Start Date
November 5 2018
End Date
August 6 2021
Last Update
April 7 2022
Active Locations (1)
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1
Leiden University Medical Centre
Leiden, South Holland, Netherlands