Clinical feasiblity and efficacy of intermittent use of a fasting mimicking diet in the treatment of type 2 diabetes

Clinical feasiblity and efficacy of intermittent use of a fasting mimicking diet in the treatment of type 2 diabetes - Fasting in diabetes Treatment (FIT)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55889

Enrollment

100

Registered

2018-09-20

Start date

2018-11-05

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

Patients will be randomized to receive ProLon, a fasting mimicking diet, for 5 days every month in addition to standard treatment according to Dutch guidelines or just standard treatment for one yea

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of type 2 diabetes mellitus - Age > 18 years and 48, or treatment with diet and metformin - BMI * 27

Exclusion criteria

Exclusion criteria: Recent myocardial infarction (

Design outcomes

Primary

Measure	Time frame
HbA1c and medication dosage required to attain HbA1c of 53 mmol/mol. Analysis of primary study parameters: The main outcome will be a binary outcome measure, successful or unsuccessful. A successful outcome is defined as either a lower dose of antidiabetic medication at the end of the study compared to the start or if HbA1c is 5 mmol/mol or more lower at the end compared to study start (or both). In addition, we will analyze the primary study parameters as a categorical outcome measure with the following three categories: 1) Successful - a lower dose or class of antidiabetic medication with an HbA1c not more than 5 mmol/mol higher at the end of the study compared to the start or; - no change in antidiabetic medication with an HbA1c that is *5 mmol/mol lower at the end of the study compared to the start 2) Stable: - no change in antidiabetic medication use and a difference in HbA1c of	—

Measure

Time frame

HbA1c and medication dosage required to attain HbA1c of 53 mmol/mol. Analysis of primary study parameters: The main outcome will be a binary outcome measure, successful or unsuccessful. A successful outcome is defined as either a lower dose of antidiabetic medication at the end of the study compared to the start or if HbA1c is 5 mmol/mol or more lower at the end compared to study start (or both). In addition, we will analyze the primary study parameters as a categorical outcome measure with the following three categories: 1) Successful - a lower dose or class of antidiabetic medication with an HbA1c not more than 5 mmol/mol higher at the end of the study compared to the start or; - no change in antidiabetic medication with an HbA1c that is *5 mmol/mol lower at the end of the study compared to the start 2) Stable: - no change in antidiabetic medication use and a difference in HbA1c of

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Secondary

Measure	Time frame
Bodyweight, waist circumference, body fat percentage (Bioelectrical Impedance Analysis), oral glucose tolerance (OGTT, glucose and insulin response), fasting glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, blood pressure, visceral fat, liver/ pancreas/heart fat (Magnetic Resonance Imaging), metabolomics, high sensitive CRP, gut microbiota architecture, quality of life (EQ-5D-5L), treatment satisfaction (DTSQs and DTSQc questionnaires), cost-effectiveness, feasibility in clinical practice. Additional focus groups: Participant experiences while following a FMD, main focus on adherence and lifestyle changes.	—

Measure

Time frame

Bodyweight, waist circumference, body fat percentage (Bioelectrical Impedance Analysis), oral glucose tolerance (OGTT, glucose and insulin response), fasting glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, blood pressure, visceral fat, liver/ pancreas/heart fat (Magnetic Resonance Imaging), metabolomics, high sensitive CRP, gut microbiota architecture, quality of life (EQ-5D-5L), treatment satisfaction (DTSQs and DTSQc questionnaires), cost-effectiveness, feasibility in clinical practice. Additional focus groups: Participant experiences while following a FMD, main focus on adherence and lifestyle changes.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)