Table 2.
Changes from baseline values in 500 mcg and 1000 mcg arms after six months (mean change with 95% CI).
| Variable | Group A and B 500 mcg (n=30) | Group A and B Placebo (n=30) | Group C and D 1000 mcg (n=29) | Group C and D Placebo (n=29) |
|---|---|---|---|---|
|
| ||||
| Anthropometric Measures | ||||
| Weight (lb) | -0.1 (-3.1 to 2.8) | -1.4 (-4.3 to 1.6) | 2.6 (-0.5 to 5.7) | 0.4 (-2.7 to 3.5) |
| Waist Circumference (cm) | -0.1 (-2.1 to 1.9) | 0.9 (-1.1 to 2.9) | 0.1 (-2.7 to 2.8) | 1.6 (-1.2 to 4.3) |
| BMI (kg/m2) | -0.1 (-0.6 to 0.5) | -0.3 (-0.8 to 0.2) | 0.4 (-0.1 to 0.9) | -0.0 (-0.6 to 0.5) |
|
| ||||
| Blood Pressure | ||||
| Systolic (mm Hg) | 1.3 (-3.3 to 5.8) | -1.2 (-5.7 to 3.3) | 1.3 (-3.2 to 5.7) | 4.6 (0.2 to 9.0) |
| Diastolic (mm Hg) | 2.8 (-0.6 to 6.1) | 3.4 (-0.1 to 6.8) | 0.1 (-3.0 to 3.3) | 1.6 (-1.6 to 4.7) |
|
| ||||
| Lab Values | ||||
| Fasting Plasma Insulin (μU/ml) | 1.3 (-1.0 to 3.5) | -1.0 (-3.2 to 1.2) | 0.7 (-1.6 to 3.0) | -0.4 (-2.7 to 1.9) |
| 2-hour OGTT Insulin (μU/ml) | -1.0 (-11.6 to 9.6) | -7.4 (-18.0 to 3.1) | 6.3 (-28.5 to 41.2) | 5.1(-29.7 to 39.9) |
| FPG (mg/dL) | -1.0 (-3.9 to 1.9) | -2.8 (-5.7 to 0.1) | -0.3 (-3.8 to 3.1) | -0.5 (-3.9 to 3.0) |
| 2-hour OGTT Glucose (mg/dL) | 0.8 (-13.2 to 14.1) | -0.1 (-14.1 to 13.9) | -2.9 (-15.0 to 9.2) | 5.7 (-6.4 to 17.8) |
| HOMA-IR (1) | 0.3 (-0.4 to 1.1) | -0.4 (-1.1 to 0.4) | 0.2 (-0.4 to 0.8) | -0.1 (-0.7 to 0.5) |
| % Δ AHOMA-IR (1) | 7.1 (-6.7 to 21.0) | -6.9 (-20.8 to 6.9) | 5.8 (-8.8 to 20.2) | 7.1 (-7.5 to 21.6) |
| Whole blood HbA1c (%) | 0.1 (0.0 to 0.2) | 0.1 (0.0 to 0.2) | 0.0 (-0.1 to 0.1) | 0.1 (-0.0 to 0.2) |
| Serum total Cholesterol (mg/dL) | -2.9 (-11.0 to 5.1) | -6.8 (-14.9 to 1.2) | -3.1 (-12.5 to 6.3) | 2.4 (-7.0 to 11.8) |
| Serum HDL (mg/dL) | 1.9 (-0.1 to 4.0) | 0.6 (-1.4 to 2.6) | 3.1 (-2.6 to 8.9) | 0.3 (-5.4 to 6.0) |
| Serum LDL (mg/dL) | -6.4 (-13.2 to 0.4) | -7.1 (-13.9 to -0.3) | -5.9 (-14.6 to 2.8) | 0.03 (-8.7 to 8.8) |
| Serum Triglycerides (mg/dL) | 8.7 (-7.5 to 24.9) | -0.9 (-17.1 to 15.4) | -2.9 (-17.1 to 11.2) | 10.4 (-3.8 to 24.5) |
| Urine microalbumin | -1.4 (-3.9 to 1.2) | -2.5 (-5.1 to 0.1) | 1.2 (-2.8 to 5.2) | 1.6 (-2.4 to 5.6) |
| Serum creatinine (mg/dL) (μU/ml) | 0.1 (-0.0 to 0.0) | 0.0 (-0.0 to 0.0) | 0.0 (-0.0 to 0.0) | 0.0 (-0.0 to -0.0) |
|
| ||||
| Endothelial Function | ||||
| FMD Pre OGTT (% Δ) | 1.0 (-0.2 to 2.3) | 1.0 (-0.3 to 2.7) | -0.1 (-1.1 to 1.4) | -0.2 (-1.1 to 1.5) |
| FMD Pre OGTT Nitro (% Δ) | 1.2 (-1.0 to 3.5) | 0.1 (-2.1 to 2.4) | 0.1 (-1.8 to 1.9) | -0.7 (-1.1 to 2.6) |
| FMD Post OGTT (% Δ) | 0.9 (-0.5 to 2.4) | 0.1 (-1.3 to 1.6) | -1.6 (-3.0 to -0.2) | -0.4 (-1.8 to 1.0) |
| SARM Pre OGTT (2) | 0.0 (-0.0 to 0.0) | 0.0 (-0.0 to 0.0) | 0.0 (-0.0 to 0.0) | 0.0 (-0.0 to 0.0) |
| SARM Post OGTT (2) | -0.0 (-0.1 to 0.1) | 0.0 (-0.0 to 0.1) | 0.0 (-0.0 to 0.0) | 0.0 (-0.0 to 0.0) |
1
Homeostasis Model Assessment Insulin Resistance (HOMA-IR) by using the mathematical approximation, HOMA-IR = Fasting plasma insulin (mU/mL) × fasting plasma glucose (mmol/L)/22.5.
2
SARM = stimulus-adjusted response measure.