Table 1.

Trial design, visits and end points

Visit	Visit 0	Visit 1	Visit 2	Visit 3	Visit 4	Visit*	Visit 5
Time (days from the start of intervention)	−14	−6	30	90	180	270	360
Informed consent	×
History	×
Inclusion/exclusion criteria	×
Height	×	×	×	×	×	×	×
Body weight	×	×	×	×	×	×	×
Waist circumference	×	×	×	×	×	×	×
Hip circumference	×	×	×	×	×	×	×
Blood pressure	×	×	×	×	×	×	×
Glycosylated haemoglobin	×	×		×	×	×	×
Fasting plasma glucose		×					×
Liver function	×	×		×	×	×	×
Renal function	×	×		×	×	×	×
Blood lipid profiles		×		×	×	×	×
Urinary albumin/creatinine ratio		×		×	×	×	×
Fasting blood samples		×					×
Urine samples		×					×
Visual acuity		×	×	×	×	×	×
Retinal photographs	×	×		×	×	×	×
Retinal vascular calibre		×		×	×	×	×
Adverse events			×	×	×	×	×
Drug accountability		×	×	×	×	×	×

The maximum allowed time interval between screening (visit 0) and baseline examination (visit 1) will be 2 weeks (=14 days). Otherwise, a new screening will be conducted before the participants are included in the study.

*Additional visit at 9 months is warranted for patient with type 1 diabetes.