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

• Sponsor: Leiden University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03811587
• Collaborator: Dutch Diabetes Research Foundation (Other), Health Holland (Other), IFOM, The FIRC Institute of Molecular Oncology (Other), L-Nutra (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 33
• Patients Per Site Per Month: 3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Other: Fasting Mimicking diet	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomised to the intervention or control group.Patients will be randomised to the intervention or control group.
• Masking: None (Open Label)
• Masking Description: Only measurements by assessors will be blinded.
• Primary Purpose: Treatment
• Official Title: Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
• Actual Study Start Date: Nov 5, 2018
• Actual Primary Completion Date: Aug 6, 2021
• Actual Study Completion Date: Aug 6, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Concentration of HbA1c [12 months]

2. Dosage of antidiabetic medication used [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leiden University Medical Centre	Leiden	Zuid-Holland	Netherlands

Sponsors and Collaborators

• Leiden University Medical Center
• Dutch Diabetes Research Foundation
• Health Holland
• IFOM, The FIRC Institute of Molecular Oncology
• L-Nutra

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanno Pijl, Clinical Professor, Leiden University Medical Center
• ClinicalTrials.gov Identifier: NCT03811587
• Other Study ID Numbers: NL63892.058.18 - P18.049
• First Posted: Jan 22, 2019
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hanno Pijl, Clinical Professor, Leiden University Medical Center: Diet; Fasting
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 7, 2022