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Completed

NCT Number: NCT03811587

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Centre

Leiden, South Holland, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fasting Mimicking diet

Other

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 outcomes

  1. Concentration of HbA1c

    Time frame: 12 months

  2. Dosage of antidiabetic medication used

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Dutch Diabetes Research Foundation
  • Health Holland
  • IFOM ETS - The AIRC Institute of Molecular Oncology
  • L-Nutra

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2019
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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