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NCT03811587 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03811587
Other study ID # NL63892.058.18 - P18.049
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2018
Est. completion date August 6, 2021

Study information
Verified date April 2022
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 100
Est. completion date August 6, 2021
Est. primary completion date August 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 74 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
Netherlands Leiden University Medical Centre Leiden Zuid-Holland

Sponsors (5)
Lead Sponsor Collaborator
Leiden University Medical Center Dutch Diabetes Research Foundation, Health Holland, IFOM, The FIRC Institute of Molecular Oncology, L-Nutra

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of HbA1c 12 months
Primary Dosage of antidiabetic medication used 12 months
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