Table 2

Schedule of study-related procedures and assessments

	Enrolment	Baseline		Intervention period
Study visits		V₀	V₁	V₂	V₃	V₄	V₅	V₆
Time points (month)		−1	0	3	6	9	11	12
Enrolment
Eligibility screening	√
Informed consent	√
Optimising medications	(√)
Randomisation			√
Assessments
Demographics	√
Continuous glucose monitoring		√					√
Diurnal urine collection		√		√	√	√	√
Diurnal blood pressure		√					√
Holter monitoring		√					√
MR imaging		√					√
DXA scan		√					√
Muscle strength tests		√					√
Anthropometry including body weight	√		√	√	√	√		√
Fasting blood sampling			√	√	√	√		√
Oral glucose tolerance test			√					√
Questionnaires		√	√	√	√	√		√
Interviews		√	√		√			√
Adherence to study protocol
Food records		√		√	√	√		√
Diet history interviews and FFQ		√		√	√	√	√
Query of adverse events				√	√	√	√	√
Query of medication changes	√	√		√	√	√	√
Query of alcohol consumption	√	√		√	√	√	√

Overview of study-related procedures and assessments conducted during the study duration. Baseline (V₀–V₁) and end of treatment (V₅–V₆) measurements were performed over a 3-week period for logistic reasons.
DXA, dual-energy X-ray absorptiometry; FFQ, Food Frequency Questionnaire.