Skip to main content

Table 2 Detailed schedule of assessments during follow up

From: 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

Follow up

Screening

Baseline

In the first month

In the second month

In the fourth month

After six months

In the eighth month

In the tenth month

In the twelfth month

After twelve months

 

T0

T1

T2

T3

T4

T5

T6

T7

T8

Participant characteristics

X

         

Medical history

X

         

Anthropometrics

X

X

X

X

X

X

X

X

X

X

Blood pressure

X

X

X

X

X

X

X

X

X

X

Medication dosage

X

X

   

X

   

X

Adverse Events

 

X

   

X

   

X

Serious Adverse Events

 

X

X

X

X

X

X

X

X

X

MRI

 

X

   

X

   

X

Stool sample (including registration form)

 

X

X

  

X

   

X

Finger-stick ketone bodies test

 

X

X

 

X

 

X

 

X

 

Questionnaires

 Cost questionnaire

    

X

X

 

X

 

X

 Quality of Life (EQ-5D-5L)

 

X

  

X

X

 

X

 

X

 Treatment satisfaction (DTSQs)

 

X

  

X

X

 

X

 

X

 Treatment satisfaction (DTSQc)

         

X

 Eating habits (DHD-FFQ)

 

X

   

X

   

X

 Physical activity (SQUASH)

 

X

   

X

   

X

 MRI safety questionnaire

X

X

   

X

   

X

Fasting blood sample

 HbA1c

X

X

   

X

   

X

 Glucose

X

X

X

 

X

X

X

 

X

X

 Creatinin

X

         

 ASAT

X

         

 ALAT

X

         

 Haemoglobin

X

         

 Red cell indices

X

         

 Leucocytes

X

         

 Thrombocytes

X

         

 OGTT (5x glucose and 5x insulin)

 

X

   

X

   

X

 Total cholesterol

 

X

   

X

   

X

 Low-density lipoprotein (LDL)

 

X

   

X

   

X

 High-density lipoprotein (HDL)

 

X

   

X

   

X

 Triglycerides

 

X

   

X

   

X

 High sensitive CRP

 

X

   

X

   

X

 Metabolomics

 

X

       

X

 IGF-1a

 

X

X

 

X

 

X

 

X

 

 Insulin-like growth factor-binding protein (IGF-BP-1)a

 

X

X

 

X

 

X

 

X

 
  1. Laboratory tests with a a will only be performed in the FMD group