|
Procedure |
Visit 1 (Information & Screening at CIM) Pre-study |
Visit 2 (Run-in visit at CIM or MECNRU) Week -2 |
Visit 3 (visit at CIM) Week 0 |
Visit 4 (visit at CIM or MECNRU) Week 4 |
Visit 5 (visit at CIM or MECNRU) Week 8 |
Visit 6 (visit at CIM) Week 12 |
Visit 7 (visit at CIM) Week 13 |
|---|---|---|---|---|---|---|---|
|
Informed consent |
X |
|
|
|
|
|
|
|
Questionnaires |
X |
|
X |
X |
X |
X |
X |
|
Blood draw |
X |
|
X |
X |
X |
X |
X |
|
Urine sample |
X |
|
|
|
X |
||
|
Chest X-ray |
X |
|
|
|
|
||
|
Electrocardiogram |
X |
|
|
|
|
|
|
|
Physical exam |
X |
|
|
|
if needed |
||
|
Weight, height, waist circumference, blood pressure & pulse |
X |
|
X |
X |
X |
X |
X |
|
Oral glucose tolerance test |
X |
|
|
|
|
|
X |
|
Dual energy X-ray absorptiometry |
|
X |
|
X |
|
||
|
Insulin sensitivity test |
|
X |
|
X |
|
||
|
Resting energy expenditure |
|
X |
|
X |
|
||
|
Fat biopsy |
|
X |
|
X |
|
||
|
Dietary counseling & dairy product distribution |
|
X |
X |
X |
X |
|
|
|
24-hour food recall |
X |
|
|
|
|
|
|
|
3-day food diaries (2 weekdays and 1 weekend day) |
|
|
X |
X |
X |
X |
|
|
Accelerometer / step counter (2 weekdays and 1 weekend day) |
|
|
X |
|
|
X |
|
|
Duration of Visit |
4 hours |
1 hour |
6 hours |
1 hour |
1 hour |
6 hours |
3 hours |
|
Special Preparation |
Fasting Overnight |
|
Fasting Overnight Hold Medications |
Fasting Overnight |
Fasting Overnight |
Fasting Overnight Hold Medications |
Fasting Overnight |