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 | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
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 | Â | Â | Â | X | Â | Â | Â | X |
Adverse Events | Â | X | Â | Â | Â | X | Â | Â | Â | X |
Serious Adverse Events | Â | X | X | X | X | X | X | X | X | X |
MRI | Â | X | Â | Â | Â | X | Â | Â | Â | X |
Stool sample (including registration form) | Â | X | X | Â | Â | X | Â | Â | Â | X |
Finger-stick ketone bodies test | Â | X | X | Â | X | Â | X | Â | X | Â |
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 |  |