Schedule of study procedures

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

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