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

Table 2 Detailed schedule of assessments during follow up

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
Follow up		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-1^a		X	X		X		X		X
Insulin-like growth factor-binding protein (IGF-BP-1)^a		X	X		X		X		X

ISSN: 1472-6823