Table 2.
Investigation schedule
|
Procedure |
Inclusion |
Treatment period |
Follow-up |
|
|---|---|---|---|---|
| |
M0 |
M1 |
M2 |
M3 |
| Week 0 | Week 12 | Week 24 | Week 48 | |
|
Written consent |
X |
|
|
|
|
Medical history |
X |
X |
X |
X |
|
Randomization |
X |
|
|
|
|
Study drug dispensing |
X |
X |
|
|
|
End of study drug treatment |
|
|
X |
|
|
Compliance |
|
X |
X |
X |
|
Adverse events monitoring |
|
X |
X |
X |
|
Previous and concomitant treatment |
X |
X |
X |
X |
|
Vital signs and physical examination |
X |
X |
X |
X |
|
Anthropometry + TANITA® bioimpedance |
X |
X |
X |
X |
|
Abdominal utrasound |
X |
|
X |
X |
|
aLiver biopsy |
X |
|
|
|
|
Dietary assessment: |
|
|
|
|
| - dietetic counseling |
X |
X |
X |
X |
| - 3 day food record |
X |
|
|
|
| - FFQ |
X |
|
X |
|
|
Physical activity: |
|
|
|
|
| - general counselling |
X |
X |
X |
X |
| - IPAQ |
X |
|
X |
|
|
Laboratory tests: |
|
|
|
|
| - hematology |
X |
|
X |
|
| - ALT,AST, GGTP, bilirubin, INR |
X |
X |
X |
X |
| - fasting glucose, insulin |
X |
X |
X |
X |
| - OGTT glucose, insulin 0-240mins |
X |
|
|
|
| - fasting lipids profile |
X |
|
X |
X |
| - adipokines, cytokines, antioxidants |
X |
|
X |
|
| - fatty acid composition of plasma phospholipids |
X |
|
X |
|
|
aDEXA |
X |
|
X |
|
|
aMRI - body fat distribution |
X |
|
X |
|
| a1H-MRS - liver fat content | X | X | ||
aDone in selected patients.
Vital signs: mean BP, HR and temperature.
Anthropometry includes measurements of body weight and height, waist, hips and mid upper arm circumference (IOTF, WHO), triceps, abdominal and subscapular skin fold thickness.
OGTT glucose and insulin measurements were performed in intervals every 30 minutes from 0 to 240 minutes.