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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Fasting Mimicking diet
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diet, Fasting

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Leiden University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Control group

Arm Description

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.

Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner.

Outcomes

Primary Outcome Measures

Concentration of HbA1c
Dosage of antidiabetic medication used

Secondary Outcome Measures

Full Information

First Posted
January 13, 2019
Last Updated
April 6, 2022
Sponsor
Leiden University Medical Center
Collaborators
Dutch Diabetes Research Foundation, Health Holland, IFOM ETS - The AIRC Institute of Molecular Oncology, L-Nutra
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1. Study Identification

Unique Protocol Identification Number
NCT03811587
Brief Title
Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
Official Title
Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
August 6, 2021 (Actual)
Study Completion Date
August 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Dutch Diabetes Research Foundation, Health Holland, IFOM ETS - The AIRC Institute of Molecular Oncology, L-Nutra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diet, Fasting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomised to the intervention or control group.
Masking
None (Open Label)
Masking Description
Only measurements by assessors will be blinded.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner.
Intervention Type
Other
Intervention Name(s)
Fasting Mimicking diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Concentration of HbA1c
Time Frame
12 months
Title
Dosage of antidiabetic medication used
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanno Pijl, MD, PhD
Organizational Affiliation
Leiden Univerity Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Centre
City
Leiden
State/Province
Zuid-Holland
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32580710
Citation
van den Burg EL, Schoonakker MP, van Peet PG, van den Akker-van Marle ME, Willems van Dijk K, Longo VD, Lamb HJ, Numans ME, Pijl H. Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes. BMC Endocr Disord. 2020 Jun 24;20(1):94. doi: 10.1186/s12902-020-00576-7. Erratum In: BMC Endocr Disord. 2020 Nov 4;20(1):164.
Results Reference
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Learn more about this trial

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

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