Table 1.
Participant demographics, anthropometrics, body composition, cardiometabolic risk factors, and quality of life expressed as mean (SD) or frequency (%) where indicated.
| All Enrolled Participants (pre-MRT) | All Randomized Participants (post-MRT) | Randomized to Exenatide XR | Randomized to Placebo | |
|---|---|---|---|---|
| N = 100 | N = 66 | N = 33 (50%) | N = 33 (50%) | |
| Male | 47 (47%) | 35 (53%) | 15 (45%) | 20 (61%) |
| Age (years) | 15.8 (1.5) | 16 (1.5) | 15.9 (1.6) | 16.1 (1.5) |
| Tanner Stage | ||||
| Stage 2 | 3 (3%) | 2 (3%) | 1 (3%) | 1 (3%) |
| Stage 3 | 8 (8%) | 3 (5%) | 1 (3%) | 2 (6%) |
| Stage 4 | 20 (20%) | 9 (14%) | 4 (12%) | 5 (15%) |
| Stage 5 | 69 (69%) | 49 (74%)1 | 24 (73%) | 25 (76%) |
| Race/Ethnicity | ||||
| Non-Hispanic | 85 (85%) | 58 (88%) | 27 (82%) | 31 (94%) |
| Hispanic2 | 13 (13%) | 7 (11%) | 5 (15%) | 2 (6%) |
| White | 74 (74%) | 54 (82%) | 26 (79%) | 28 (85%) |
| Black | 8 (8%) | 5 (8%) | 3 (9%) | 2 (6%) |
| Asian | 1 (1%) | 0 (0%) | 0 (0%) | 0 (0%) |
| American Indian | 1 (1%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Race - Multiple | 10 (10%) | 5 (8%) | 3 (9%) | 2 (6%) |
| Race - missing | 4 (4%) | 2 (3%) | 1 (3%) | 1 (3%) |
| Race - Other | 2 (2%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Highest Level of Parent/Guardian Education3 | ||||
| Some High School | 4 (4%) | 2 (3%) | 2 (6%) | 0 (0%) |
| High School/GED | 32 (32%) | 21 (32%) | 7 (21%) | 14 (42%) |
| College Graduate | 52 (52%) | 35 (53%) | 20 (61%) | 15 (45%) |
| Postgraduate | 9 (9%) | 6 (9%) | 4 (12%) | 2 (6%) |
| Eligible for Free or Reduced Lunch4 | 26 (26%) | 14 (21%) | 7 (21%) | 7 (21%) |
| Height (cm) | 169.5 (8.8) | 171.2 (8.2) | 169.7 (8) | 172.7 (8.3) |
| Weight (kg) | 113.5 (20.4) | 108.5 (17.6) | 105.6 (17.7) | 111.4 (17.2) |
| BMI (kg/m2) | 39.4 (4.9) | 36.9 (4.4) | 36.5 (4.3) | 37.3 (4.6) |
| Percent of 95th BMI percentile | 140.4 (16.7) | 131.1 (14.5) | 129.5 (13.2) | 132.6 (15.8) |
| Body Composition5 | ||||
| Total Body Fat Mass (kg) | 53.1 (12.2) | 50.1 (11.1) | 48.8 (10.1) | 51.4 (11.9) |
| Percent Body Fat (%) | 49.1 (5.1) | 47.5 (5.5) | 47.7 (4.8) | 47.4 (6.1) |
| Visceral Adipose Tissue (kg) | 1.49 (0.77) | 1.29 (0.65) | 1.23 (.72) | 1.35 (0.57) |
| Subcutaneous Adipose Tissue (kg) | 51.60 (11.8) | 48.8 (10.6) | 47.5 (9.5) | 50.0 (11.6) |
| Total Lean Muscle Mass (kg) | 55.2 (9.9) | 54.9 (9.6) | 53.5 (10.1) | 56.4 (9.1) |
| SBP (mmHg) | 121(10) | 117(9) | 117(10) | 117(8) |
| DBP (mmHg) | 70 (8) | 66 (9) | 67 (8) | 65 (9) |
| Heart rate (bpm) | 78 (12) | 74 (12) | 73 (10) | 74 (14) |
| Total Cholesterol (mg/dL) | 159.5 (31.1) | 133.6 (24.6) | 130.7 (22.6) | 136.5 (26.5) |
| LDL-Cholesterol (mg/dL) | 95 (28.6) | 78.5 (23.4) | 75.6 (22.2) | 81.3 (24.6) |
| HDL-Cholesterol (mg/dL) | 43.8 (12.4) | 37.9 (14.6) | 37.8 (9.4) | 37.9 (18.6) |
| Triglycerides (mg/dL) | 105.9 (45.7) | 95.7 (33.1) | 90 (28.1) | 101.4 (37) |
| Triglyceride/HDL ratio | 2.7 (1.6) | 2.8 (1.4) | 2.6 (1.3) | 3 (1.5) |
| Glucose (mg/dL) | 78.5 (10.9) | 76.7 (8.9) | 76.7 (8.1) | 76.7 (9.7) |
| Insulin (μIU/mL)6 | 19.6 (11.5) | 11.6 (6.7) | 11.1 (4.8) | 12.1 (8.3) |
| Hemoglobin A1c (%) | 5.5 (0.3) | 5.2 (0.2) | 5.2 (0.2) | 5.2 (0.3) |
| IWQOL-Kids Total | 78.9 (14.5) | 82 (17.7) | 84.3 (11.1) | 79.8 (22.3) |
3 participants did not have Tanner stage readings following meal replacement therapy
2 participants did not indicate their ethnicity
3 participants did not indicate their highest level of parent/guardian education
2 participants did not indicate their eligibility for free or reduced lunch
1 participant did not have body composition readings at enrollment
3 participants did not have insulin readings at enrollment; 4 participants did not have insulin readings following meal replacement therapy.
To convert cholesterol to mmol/L, multiply values by 0.0259
To convert triglycerides to mmol/L, multiply values by 0.0113
To convert glucose to mmol/L, multiply values by 0.0555
To convert insulin to pmol/L, multiply values by 6.945