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| Name | Class |
|---|---|
| Dutch Diabetes Research Foundation | OTHER |
| Health Holland | OTHER |
| IFOM ETS - The AIRC Institute of Molecular Oncology | OTHER |
| L-Nutra |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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. |
|
| Control group | No Intervention | Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of HbA1c | 12 months | |
| Dosage of antidiabetic medication used | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanno Pijl, MD, PhD | Leiden Univerity Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Centre | Leiden | South Holland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41214519 | Derived | van den Burg EL, van Peet PG, Schoonakker MP, Esmeijer AC, Lamb HJ, Numans ME, Pijl H, van den Akker-van Marle ME. Cost-effectiveness of a periodic fasting-mimicking diet programme in patients with type 2 diabetes: a trial-based analysis and a lifetime model-based analysis. BMC Prim Care. 2025 Nov 10;26(1):351. doi: 10.1186/s12875-025-03027-1. | |
| 40425403 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| UNKNOWN |
Patients will be randomised to the intervention or control group.
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Only measurements by assessors will be blinded.
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| Schoonakker MP, van den Burg EL, van Peet PG, le Cessie S, Penny E, Numans ME, Pijl H, Lamb HJ. A fasting-mimicking diet programme reduces abdominal adipose tissue while preserving abdominal muscle mass in persons with type 2 diabetes. Nutr Metab Cardiovasc Dis. 2025 Oct;35(10):104111. doi: 10.1016/j.numecd.2025.104111. Epub 2025 Apr 30. |
| 40020647 | Derived | van den Burg EL, Schoonakker MP, van Peet PG, le Cessie S, Numans ME, Pijl H, Lamb HJ. A fasting-mimicking diet programme reduces liver fat and liver inflammation/fibrosis measured by magnetic resonance imaging in patients with type 2 diabetes. Clin Nutr. 2025 Apr;47:136-145. doi: 10.1016/j.clnu.2025.02.017. Epub 2025 Feb 18. |
| 39934050 | Derived | Roos PR, van den Burg EL, Schoonakker MP, van Peet PG, Numans ME, Pijl H, Westenberg JJM, Lamb HJ. Fasting-mimicking diet in type 2 diabetes reduces myocardial triglyceride content: A 12-month randomised controlled trial. Nutr Metab Cardiovasc Dis. 2025 Jul;35(7):103860. doi: 10.1016/j.numecd.2025.103860. Epub 2025 Jan 9. |
| 38698355 | Derived | van den Burg EL, Schoonakker MP, Korpershoek B, Sommeling LE, Sturm CA, Lamb HJ, Pijl H, Numans ME, Adriaanse MA, van Peet PG. Self-initiated lifestyle changes during a fasting-mimicking diet programme in patients with type 2 diabetes: a mixed-methods study. BMC Prim Care. 2024 May 2;25(1):148. doi: 10.1186/s12875-024-02405-5. |
| 38546821 | Derived | van den Burg EL, Schoonakker MP, van Peet PG, van den Akker-van Marle EM, Lamb HJ, Longo VD, Numans ME, Pijl H. Integration of a fasting-mimicking diet programme in primary care for type 2 diabetes reduces the need for medication and improves glycaemic control: a 12-month randomised controlled trial. Diabetologia. 2024 Jul;67(7):1245-1259. doi: 10.1007/s00125-024-06137-0. Epub 2024 Mar 28. |
| 32580710 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |