Table 3.
Visit number (month) |
Screening visit |
1 (Baseline) |
2 (3) |
3 (6) |
4 (9) |
5 (12) |
6 (15) |
7 (18) |
8 (21) |
9 (24) |
10 (27) |
11 (30) |
12 (33) |
13 (36) |
14 (39) |
15 (42) |
16 (45) |
17 (48) |
18 (51) |
19 (54) |
20 (57) |
21 (60) |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Informed consent | X | |||||||||||||||||||||
Review inclusion/exclusion | X | |||||||||||||||||||||
Initial medical history | X | |||||||||||||||||||||
Interval medical history | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Vital signs: (blood pressure, pulse, temperature, respiratory rate) | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Measurement of height | X | |||||||||||||||||||||
Weight, BMI, waist circumference | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Physical examination | X | X | ||||||||||||||||||||
Oral glucose tolerance test | X | X | X | X | X | X | ||||||||||||||||
HbA1c, electrolytes, hematology, lipid profile | X | X | X | X | X | X | ||||||||||||||||
Fasting plasma glucose & insulin | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Urine microalbumin/ creatinine ratio | X | X | X | X | X | X | ||||||||||||||||
Adipocytokines (TNF-alpha, IL-1, IL-6, leptin, adiponectin, resistin) | X | X | X | X | X | X | ||||||||||||||||
Block Food Frequency Questionnaire | X | X | X | X | X | X | ||||||||||||||||
NHANES III Physical Activity Questionnaire | X | |||||||||||||||||||||
Modifiable Activities Questionnaire | X | X | X | X | X | X | ||||||||||||||||
Socioeconomic Status Questionnaire | X | X | X | X | X | X | ||||||||||||||||
Body composition (DEXA) | X | X | X | X | X | |||||||||||||||||
Indirect calorimetry | X | X | X | |||||||||||||||||||
Intravenous glucose tolerance test | X | X | X | X | X | |||||||||||||||||
Insulin sensitivity test (euglycemic clamp) | X | X | X | |||||||||||||||||||
Leptin secretion test | X | X | ||||||||||||||||||||
Genetic repository blood sample | X |