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 |