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

April 6, 2022 updated by: Hanno Pijl, Leiden University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands
        • Leiden University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment group
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.
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.
NO_INTERVENTION: Control group
Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of HbA1c
Time Frame: 12 months
12 months
Dosage of antidiabetic medication used
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Health Holland
Dutch Diabetes Research Foundation
IFOM, The FIRC Institute of Molecular Oncology
L-Nutra

Investigators

  • Principal Investigator: Hanno Pijl, MD, PhD, Leiden Univerity Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 5, 2018

Primary Completion (ACTUAL)

August 6, 2021

Study Completion (ACTUAL)

August 6, 2021

Study Registration Dates

First Submitted

January 13, 2019

First Submitted That Met QC Criteria

January 17, 2019

First Posted (ACTUAL)

January 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL63892.058.18 - P18.049

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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