TABLE 1.
Baseline Characteristics of treatment groups.
| Units (), Normal range or cutoff [] | Metformin (n=55) | Placebo (n=59) | ||
|---|---|---|---|---|
| Race | n | % | n | % |
| Black | 20 | 36% | 21 | 36% |
| White | 33 | 60% | 38 | 64% |
| Other | 2 | 4% | 0 | 0% |
| Biometric | Mean (SD) | Mean (SD) | ||
| Age (years) | 55 | 29.0 (4.5) | 59 | 28.8 (4.6) |
| Weight (kg) | 55 | 102.7 (22.7) | 59 | 104.1 (23.2) |
| BMI (kg/m2) [<25] | 55 | 38.0 (7.8) | 59 | 38.3 (8.0) |
| Waist (inches) [<35] | 54 | 42.7 (6.9) | 59 | 42.2 (7.3) |
| Ferriman-Gallwey Score [< 6] | 55 | 17.7 (8.3) | 59 | 19.1 (8.9) |
| Total Acne Lesion Count | 43 | 4.4 (7.4) | 46 | 2.6 (4.1) |
| Systolic Blood Pressure (mmHg) [<130] | 55 | 122.1 (17.6) | 59 | 120.0 (14.9) |
| Diastolic Blood Pressure (mmHg) [<85] | 55 | 79.5 (11.7) | 59 | 76.8 (10.2) |
| Hormones | ||||
| Testosterone (ng/dL) [< 50] | 54 | 73.6 (36.9) | 59 | 77.3 (36.9) |
| SHBG (nmol/L) [20 – 130] | 54 | 28.1 (25.4) | 56 | 26.5 (12.9) |
| Free Androgen Index [<1.5] | 53 | 13.7 (14.5) | 56 | 12.5 (8.8) |
| Estradiol (pg/ml) [20–350] | 50 | 45.7 (33.5) | 57 | 45.2 (32.2) |
| LH (mIU/ml) [0.6 – 16.3] | 54 | 8.7 (4.0) | 58 | 9.4 (8.3) |
| FSH (mIU/ml) [1.09 – 10.0] | 53 | 5.0 (1.9) | 58 | 5.0 (2.0) |
| Lipid Parameters | ||||
| Cholesterol (mg/dl) [<200] | 53 | 187.4 (55.4) | 55 | 173.0 (32.6) |
| HDL (mg/dl) [>50] | 53 | 37.1 (15.8) | 55 | 36.7 (13.2) |
| LDL (mg/dl) [<100] | 52 | 123.9 (45.7) | 55 | 114.8 (32.2) |
| Triglycerides (mg/dl) [<150] | 54 | 128.5 (87.4) | 55 | 107.8 (48.1) |
| Glycemic Parameters from OGTT | ||||
| Fasting Glucose (mg/dl) [< 100] | 55 | 89.4 (11.0) | 55 | 88.4 (8.6) |
| Fasting Insulin (μU/ml) [<35] | 51 | 12.9 (9.4) | 49 | 16.6 (13.9) |
| AUC Glucose (μU · min/mL) | 54 | 15,808 (4,089) | 55 | 15,754 (3,354) |
| AUC Insulin (mg · min/dL) | 51 | 11,242 (6,395) | 50 | 11,030 (6,565) |
| Insulinogenic Index | 50 | 2.2 (2.0) | 43 | 2.0 (3.2) |
| Insulin Sensitivity Index | 50 | 4.9 (4.5) | 44 | 5.5 (5.6) |
| Ultrasound Parameters | ||||
| Left Ovarian Volume (cm3) [< 10] | 54 | 10.3 (4.8) | 53 | 11.7 (5.7) |
| Right Ovarian Volume (cm3) [< 10] | 53 | 12.0 (6.6) | 54 | 13.0 (7.8) |
| Largest Follicle Diameter (mm) | 50 | 8.2 (3.9) | 52 | 9.8 (5.9) |
| DXA Parameters | ||||
| BMD (g/cm2) [1.00–1.17] | 49 | 1.22 (0.12) | 53 | 1.21 (0.12) |
| Total Lean (g) | 49 | 55,867 (8,340) | 53 | 56,455 (8,122) |
| Total Fat (g) | 49 | 40,923 (12,082) | 53 | 40,165 (11,523) |
| Central Abdominal Fat (g) | 47 | 3,188 (1,061) | 52 | 3,051 (952) |
| Abdominal Fat (g) | 47 | 7,208 (2,299) | 52 | 6,985 (2,072) |
| Central-to-total body fat ratio | 47 | 0.08 (0.01) | 52 | 0.08 (0.01) |
| % Body fat [25–31] | 49 | 41.4 (6.0) | 53 | 40.8 (5.8) |
| Submaximal Exercise Testing | ||||
| Estimated VO2 max ml/kg/min [31–43] | 49 | 24.3 (4.7) | 54 | 23.8 (5.8) |
| PCOS QOL Parameters | ||||
| Domain: Emotion Mean Score | 55 | 4.30 (1.25) | 59 | 3.63 (1.17) |
| Domain: Body Hair Mean Score | 55 | 3.47 (1.87) | 59 | 2.98 (1.55) |
| Domain: Weight Mean Score | 55 | 2.32 (1.43) | 59 | 1.98 (1.16) |
| Domain: Menstrual Problems Mean Score | 55 | 3.69 (1.07) | 59 | 3.36 (1.08) |
| Overall Physical Well-Being | 55 | 3.75 (1.48) | 59 | 3.46 (1.33) |
| Overall Emotional Well-Being | 55 | 4.16 (1.58) | 59 | 3.61 (1.33) |
| Overall General Well-Being | 55 | 4.31 (1.33) | 59 | 3.88 (1.22) |