Article Figures & Data
Figures
- Figure 1.
CONSORT diagram for the study indicating reasons for participant exclusion or ineligibility. *, Abnormal endometrial biopsy showed complex atypical hyperplasia (precancerous lesion). ALT, alanine aminotransferase; QUICKI, quantitative insulin-sensitivity check index; TSH, thyroid-stimulating hormone; DXA, dual energy X-ray absorptiometry.
- Figure 2.
Paired pre- and post-intervention endometrial proliferation by individual treatment group.
Tables
- Table 1.
Demographics and clinical characteristics of study participants
Placebo + no lifestyle (n = 8) Placebo + lifestyle (n = 7) Metformin + no lifestyle (n = 7) Metformin + lifestyle (n = 7) Total N (%) N (%) N (%) N (%) N (%) Age (years), mean (SD), range 60.0 (4.5) (55–66) 57.1 (3.3) (53–61) 55.8 (5.2) (50–65) 57.5 (4.4) (50–61) 57.5 (4.4) (50–66) BMI, mean (SD), range 36.7 (5.5) (29.7–46.6) 39.7 (5.1) (33.7–46.5) 38.3 (5.1) (32.0–46.6) 42.2 (6.7) (32.1–50.7) 39.1 (5.7) (29.7–50.7) Race Black 4 (50.0) 2 (28.6) 1 (14.3) 5 (71.4) 12 (41.4) White 4 (50.0) 4 (57.1) 5 (71.4) 2 (28.6) 15 (51.7) More than one race 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 1 (3.4) Other 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 1 (3.4) Ethnicity Hispanic 2 (25.0) 2 (28.6) 1 (14.3) 0 (0.0) 5 (17.2) Non-Hispanic 6 (75.0) 5 (71.4) 6 (85.7) 7 (100.0) 24 (82.8) Education Finished high school 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 1 (3.4) Technical/vocational degree 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 1 (3.4) Some college or 2-year degree 5 (62.5) 3 (42.9) 1 (14.3) 3 (42.9) 12 (41.4) Bachelors 3 (37.5) 2 (28.6) 4 (57.1) 3 (42.9) 12 (41.4) Masters 0 (0.0) 1 (14.3) 1 (14.3) 1 (14.3) 3 (10.3) Marital status Single 1 (12.5) 1 (14.3) 1 (14.3) 1 (14.3) 4 (13.8) Married 4 (50.0) 4 (57.1) 4 (57.1) 1 (14.3) 13 (44.8) Divorced 1 (12.5) 2 (28.6) 2 (28.6) 3 (42.9) 8 (27.6) Living with a significant other 0 (0.0) 0 (0.0) 0 (0.0) 1 (14.3) 1 (3.4) Widow 2 (25.0) 0 (0.0) 0 (0.0) 1 (14.3) 3 (10.3) Children No 2 (25.0) 1 (14.3) 0 (0.0) 1 (14.3) 4 (13.8) Yes 6 (75.0) 6 (85.7) 7 (100.0) 6 (85.7) 25 (86.2) Comorbidities None 3 (37.5) 5 (71.4) 4 (57.1) 3 (42.9) 15 (51.7) High cholesterol 0 (0.0) 0 (0.0) 0 (0.0) 1 (14.3) 1 (3.4) Hypertension 4 (50.0) 2 (28.6) 1 (14.3) 3 (42.9) 10 (34.5) Othera 1 (12.5) 0 (0.0) 2 (28.6) 0 (0.0) 3 (10.3) NOTE: The table includes all participants that were randomized and started the intervention.
↵aComorbidities reported as “Other” were described as hypothyroid (n = 2) and asymptomatic heart murmur (n = 1).
- Table 3.
Changes in endometrial proliferation and blood-based biomarkers at 16 weeks by intervention
Effect Mean change 95% LB 95% UB P Ki-67 (%) Metformin (ref: no metformin) −2.74 −8.75 3.27 0.352 Lifestyle (ref: no lifestyle) −3.68 −9.69 2.34 0.216 Estradiol (pg/mL) Metformin −0.62 −6.95 5.71 0.841 Lifestyle 0.29 −6.04 6.62 0.925 Estrone (pg/mL) Metformin −1.52 −8.94 5.91 0.675 Lifestyle −0.20 −7.62 7.23 0.957 DHEA-S (mcg/dL) Metformin 33.67 16.10 51.25 0.001 Lifestyle −6.20 −23.78 11.37 0.473 SHBG (nmol/L) Metformin 5.06 −2.31 12.43 0.169 Lifestyle 9.37 1.99 16.74 0.015 Adiponectin (mcg/mL) Metformin 0.93 −0.38 2.25 0.155 Lifestyle 0.64 −0.67 1.95 0.324 IGF-I (ng/mL) Metformin −9.39 −21.72 2.94 0.129 Lifestyle −2.90 −15.22 9.43 0.632 Omentin (ng/mL) Metformin 31.82 −107.24 170.88 0.640 Lifestyle 62.59 −76.47 201.66 0.361 Insulin (mIU/mL) Metformin −2.13 −10.12 5.86 0.586 Lifestyle −9.81 −17.80 −1.82 0.018 Glucose (mg/dL) Metformin 2.51 −3.95 8.96 0.430 Lifestyle −1.94 −8.39 4.52 0.541 FSH (mIU/mL) Metformin 0.56 −4.76 5.88 0.830 Lifestyle −0.29 −5.61 5.03 0.912 Hemoglobin (g/dL) Metformin −0.14 −0.68 0.40 0.600 Lifestyle −0.18 −0.72 0.37 0.510 A1C (%) Metformin −0.22 −0.42 −0.01 0.036 Lifestyle 0.16 −0.04 0.36 0.115 Creatine (mg/dL) Metformin −0.02 −0.10 0.05 0.543 Lifestyle −0.05 −0.12 0.03 0.199 ALT (IU/L) Metformin −1.36 −11.34 8.61 0.780 Lifestyle −1.35 −11.33 8.63 0.782 Triglycerides (mg/dL) Metformin −2.83 −30.76 25.09 0.836 Lifestyle −21.03 −48.95 6.90 0.133 FGF21 (pg/mL) Metformin 19.70 −82.62 122.01 0.694 Lifestyle −53.16 −155.48 49.15 0.294 C-peptide (pg/mL) Metformin −283.06 −530.89 −35.22 0.027 Lifestyle −211.04 −458.88 36.79 0.091 Leptin (pg/mL) Metformin −6746.86 −15377.00 1883.28 0.119 Lifestyle −3741.67 −12371.81 4888.47 0.379 Visfatin (pg/mL) Metformin −70.00 −1792.21 1652.21 0.934 Lifestyle −1167.96 −2890.17 554.25 0.174 NOTE: P value cutoff for statistical significance = 0.0025. P value showed in bold (0.001) indicating significant difference. Table only includes participants completing the 16-week intervention. LB, lower bound; UB, upper bound.
- Table 4.
Adverse events reported by individual treatment group
Placebo + no lifestyle Placebo + lifestyle Metformin + no lifestyle Metformin + lifestyle Adverse event Month 1 Month 2 Month 3 Month 4 Month 1 Month 2 Month 3 Month 4 Month 1 Month 2 Month 3 Month 4 Month 1 Month 2 Month 3 Month 4 Blurred vision 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 Fatigue 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Flu like symptoms 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 Headache 2 0 0 0 3 0 0 0 3 2 1 1 1 0 0 2 Insomnia 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 Cough 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 Hot flashes 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 GI disturbance 4 1 2 0 1 1 0 1 5 3 2 1 3 1 1 1 Pain 1 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 Muscle weakness 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Total 10 3 4 1 4 1 0 1 10 7 3 2 5 1 1 4 NOTE: All reported adverse events were grade 1 or 2.
Volume 11, Issue 8
