Table 1.
Baseline Characteristics by Treatment Group
| Characteristics |
Leuprolide Group (n=12) |
Metformin Group (n=12) |
Placebo Group (n=11) |
Total (n=35) |
|---|---|---|---|---|
| Age, yr |
58 (7) |
56 (4) |
62 (7) |
58 (7) |
| Race, no. (%) | ||||
| White | 6 (50) | 6 (50) | 8 (73) | 20 (57) |
| African-American | 5 (42) | 6 (50) | 3 (27) | 14 (40) |
| Asian |
1 (8) |
0 |
0 |
1 (3) |
| Current smoking, no. (%) |
3 (25) |
3 (25) |
1 (9) |
7 (20) |
| Alcohol intake, no. (%) | ||||
| 0-1 drinks/day | 12 (100) | 11 (92) | 11 (91) | 33 (94) |
| 2 drinks/day | 0 (0) | 1 (8) | 1 (9) | 2 (6) |
| Weight, kg |
108.7 (33.7) |
96.5 (19.6) |
93.3 (11.1) |
99.7(23.9)a |
| BMI, kg/m2 |
41.2 (12.1) |
34.4 (6.1) |
34.0 (3.6) |
36.6 (8.6) |
| Waist circumference, cm |
109.9 (19.3) |
95.9 (13.0) |
98.0 (6.4) |
101.4 (15.1) |
| PCOS, no. (%) |
5 (42) |
5 (42) |
4 (36) |
14 (40) |
| Metabolic Syndrome, no. (%) | 7 (58) | 9 (75) | 8 (73) | 24 (69) |
|
Biochemical Measurements b | ||||
| Glucose (mg/dL) |
96 (90-117) |
98 (92-106) |
96 (91-110) |
97 (91-108) |
| Insulin (uIU/mL)c |
29.8 (17.8-38.5) |
21.6 (17.1-31.7) |
21.4 (10.8-22.1) |
21.9 (11.8-32.4) |
| HOMA-IR (mg/dL × uIU/mL)c |
7.06 (4.43-10.28) |
5.30 (4.46-7.86) |
4.91 (2.31-5.89) |
5.37 (2.99-8.17) |
| Total testosterone (ng/dL)c |
26 (19-35) |
19 (15-20) |
22 (17-34) |
20 (15-29) |
| SHBG (nmol/L) |
43 (32-76) |
43 (38-53) |
50 (31-54) |
43 (35-55) |
| Free testosterone (pg/mL)c |
2.8 (2.2-3.8) |
2.3 (1.8-2.7) |
3.0 (2.0-3.5) |
2.6 (2.0-3.5) |
| LH (mIU/mL)c |
28.7 (20.9-31.1) |
26.1 (17.3-29.1) |
29.8 (19.9-36.7) |
26.7 (17.9-32.6) |
| FSH (mIU/mL) |
60.9 (45.5-67.6) |
58.4 (45.9-84.7) |
80.3 (54.6-91.5) |
62.6 (49.2-80.3) |
| Estradiol (pg/mL) |
18.4 (13.5-22.1) |
10.1 (6.6-14.2) |
5.0 (5.0-18.0) |
12.4 (5.3-20.6)a |
| DHEAS (ug/dL)c |
60.4 (30.8-75.3) |
72.1 (46.3-104.9) |
39.8 (31.7-106.9) |
65.2 (37.1-89.1) |
| Total cholesterol (mg/dL) | 177 (155-194) | 209 (156-230) | 180 (152-196) | 181 (152-212) |
| LDL (mg/dL) | 97 (84-117) | 117 (85-138) | 95 (73-110) | 100 (81-132) |
| HDL (mg/dL) | 52 (47-57) | 48 (45-51) | 51 (49-61) | 51 (47-57) |
| Triglycerides (mg/dL) | 121 (84-164) | 153 (104-185) | 150 (86-173) | 132 (85-173) |
Abbreviations: BMI, body mass index; LDL, low-density lipoprotein; HDL, high-density lipoprotein; PCOS, polycystic ovary syndrome; HOMA-IR, homeostasis model assessment of insulin resistance; SHBG, sex hormone binding globulin
Data are presented as mean (SD) unless otherwise indicated. ANOVA was performed to assess differences in all continuous variables except for BMI, SHBG, estradiol, HDL, and triglycerides, for which the Kruskall-Wallis test was performed due to non-normal distribution.
Multiply by 0.0347 to convert total testosterone concentrations from ng/dl to nmol/l. Multiply by 3.47 to convert free testosterone concentrations from pg/ml to pmol/l. Multiply by 3.671 to convert estradiol from pg/mL to pmol/L.
p<0.05 for differences among groups
median (IQR)
log-transformed values were used in statistical comparisons