Measurements | Time points | ||||
---|---|---|---|---|---|
Baseline/Screening | Trial 6 m | Trial 12 m | Trial 24 m | Trial 36 m | |
Clinical Assessment | |||||
Medical History | X | X | X | X | |
Medication History | X | X | X | X | |
Physical Exam | X | X | X | X | |
Cardiovascular Risk Score | X | X | X | X | X |
Presence of Metabolic Syndrome | X | X | X | X | X |
Anthropometric | |||||
3 x Blood Pressure | X | X | X | X | X |
Height | X | X | |||
Weight | X | X | X | X | X |
Waist Circumference | X | X | X | X | X |
Blood Tests | |||||
Oral Glucose Tolerance Test | X | X | X | X | |
HbA1c | X | X | X | X | X |
Lipids | X | X | X | X | X |
Urea & Electrolytes | X | X | X | X | |
Liver Function Tests | X | X | X | X | |
Questionnaires & Lifestyle Measures | |||||
IPAQ – SF [31] | X | X | X | X | X |
DINE [27] | X | X | X | X | X |
BIPQ [30] | X | X | X | X | X |
HADS [29] | X | X | X | X | X |
15D [28] | X | X | X | X | X |
Health care resource use | X | ||||
EQ-5D [38] | X | ||||
Sleep questions | X | X | X | X | X |
7 Day Step Count | X | X | X | X | X |
Urine Sample | X | X | X | X |