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Cancer Prevention Research
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Research Article

Prospective Randomized Biomarker Study of Metformin and Lifestyle Intervention for Prevention in Obese Women at Increased Risk for Endometrial Cancer

Melinda S. Yates, Adriana M. Coletta, Qian Zhang, Rosemarie E. Schmandt, Meena Medepalli, Denise Nebgen, Beth Soletsky, Andrea Milbourne, Erma Levy, Bryan Fellman, Diana Urbauer, Ying Yuan, Russell R. Broaddus, Karen Basen-Engquist and Karen Lu
Melinda S. Yates
1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • For correspondence: msyates@mdanderson.org
Adriana M. Coletta
2Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • ORCID record for Adriana M. Coletta
Qian Zhang
1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Rosemarie E. Schmandt
1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Meena Medepalli
1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Denise Nebgen
1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Beth Soletsky
1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Andrea Milbourne
1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Erma Levy
2Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Bryan Fellman
3Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Diana Urbauer
3Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Ying Yuan
3Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Russell R. Broaddus
4Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Karen Basen-Engquist
2Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Karen Lu
1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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DOI: 10.1158/1940-6207.CAPR-17-0398 Published August 2018
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  • Figure 1.
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    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.

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    Figure 2.

    Paired pre- and post-intervention endometrial proliferation by individual treatment group.

Tables

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  • 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), range60.0 (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), range36.7 (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
     Black4 (50.0)2 (28.6)1 (14.3)5 (71.4)12 (41.4)
     White4 (50.0)4 (57.1)5 (71.4)2 (28.6)15 (51.7)
     More than one race0 (0.0)0 (0.0)1 (14.3)0 (0.0)1 (3.4)
     Other0 (0.0)1 (14.3)0 (0.0)0 (0.0)1 (3.4)
    Ethnicity
     Hispanic2 (25.0)2 (28.6)1 (14.3)0 (0.0)5 (17.2)
     Non-Hispanic6 (75.0)5 (71.4)6 (85.7)7 (100.0)24 (82.8)
    Education
     Finished high school0 (0.0)0 (0.0)1 (14.3)0 (0.0)1 (3.4)
     Technical/vocational degree0 (0.0)1 (14.3)0 (0.0)0 (0.0)1 (3.4)
     Some college or 2-year degree5 (62.5)3 (42.9)1 (14.3)3 (42.9)12 (41.4)
     Bachelors3 (37.5)2 (28.6)4 (57.1)3 (42.9)12 (41.4)
     Masters0 (0.0)1 (14.3)1 (14.3)1 (14.3)3 (10.3)
    Marital status
     Single1 (12.5)1 (14.3)1 (14.3)1 (14.3)4 (13.8)
     Married4 (50.0)4 (57.1)4 (57.1)1 (14.3)13 (44.8)
     Divorced1 (12.5)2 (28.6)2 (28.6)3 (42.9)8 (27.6)
     Living with a significant other0 (0.0)0 (0.0)0 (0.0)1 (14.3)1 (3.4)
     Widow2 (25.0)0 (0.0)0 (0.0)1 (14.3)3 (10.3)
    Children
     No2 (25.0)1 (14.3)0 (0.0)1 (14.3)4 (13.8)
     Yes6 (75.0)6 (85.7)7 (100.0)6 (85.7)25 (86.2)
    Comorbidities
     None3 (37.5)5 (71.4)4 (57.1)3 (42.9)15 (51.7)
     High cholesterol0 (0.0)0 (0.0)0 (0.0)1 (14.3)1 (3.4)
     Hypertension4 (50.0)2 (28.6)1 (14.3)3 (42.9)10 (34.5)
     Othera1 (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 2.
  • Table 3.

    Changes in endometrial proliferation and blood-based biomarkers at 16 weeks by intervention

    EffectMean change95% LB95% UBP
    Ki-67 (%)
     Metformin (ref: no metformin)−2.74−8.753.270.352
     Lifestyle (ref: no lifestyle)−3.68−9.692.340.216
    Estradiol (pg/mL)
     Metformin−0.62−6.955.710.841
     Lifestyle0.29−6.046.620.925
    Estrone (pg/mL)
     Metformin−1.52−8.945.910.675
     Lifestyle−0.20−7.627.230.957
    DHEA-S (mcg/dL)
     Metformin33.6716.1051.250.001
     Lifestyle−6.20−23.7811.370.473
    SHBG (nmol/L)
     Metformin5.06−2.3112.430.169
     Lifestyle9.371.9916.740.015
    Adiponectin (mcg/mL)
     Metformin0.93−0.382.250.155
     Lifestyle0.64−0.671.950.324
    IGF-I (ng/mL)
     Metformin−9.39−21.722.940.129
     Lifestyle−2.90−15.229.430.632
    Omentin (ng/mL)
     Metformin31.82−107.24170.880.640
     Lifestyle62.59−76.47201.660.361
    Insulin (mIU/mL)
     Metformin−2.13−10.125.860.586
     Lifestyle−9.81−17.80−1.820.018
    Glucose (mg/dL)
     Metformin2.51−3.958.960.430
     Lifestyle−1.94−8.394.520.541
    FSH (mIU/mL)
     Metformin0.56−4.765.880.830
     Lifestyle−0.29−5.615.030.912
    Hemoglobin (g/dL)
     Metformin−0.14−0.680.400.600
     Lifestyle−0.18−0.720.370.510
    A1C (%)
     Metformin−0.22−0.42−0.010.036
     Lifestyle0.16−0.040.360.115
    Creatine (mg/dL)
     Metformin−0.02−0.100.050.543
     Lifestyle−0.05−0.120.030.199
    ALT (IU/L)
     Metformin−1.36−11.348.610.780
     Lifestyle−1.35−11.338.630.782
    Triglycerides (mg/dL)
     Metformin−2.83−30.7625.090.836
     Lifestyle−21.03−48.956.900.133
    FGF21 (pg/mL)
     Metformin19.70−82.62122.010.694
     Lifestyle−53.16−155.4849.150.294
    C-peptide (pg/mL)
     Metformin−283.06−530.89−35.220.027
     Lifestyle−211.04−458.8836.790.091
    Leptin (pg/mL)
     Metformin−6746.86−15377.001883.280.119
     Lifestyle−3741.67−12371.814888.470.379
    Visfatin (pg/mL)
     Metformin−70.00−1792.211652.210.934
     Lifestyle−1167.96−2890.17554.250.174
    • 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 lifestylePlacebo + lifestyleMetformin + no lifestyleMetformin + lifestyle
    Adverse eventMonth 1Month 2Month 3Month 4Month 1Month 2Month 3Month 4Month 1Month 2Month 3Month 4Month 1Month 2Month 3Month 4
    Blurred vision0000000000000001
    Fatigue0100000001000000
    Flu like symptoms1010000000000000
    Headache2000300032111002
    Insomnia0001000000000000
    Cough1010000000000000
    Hot flashes0000000011000000
    GI disturbance4120110153213111
    Pain1000000010001000
    Muscle weakness1100000000000000
    Total103414101107325114
    • NOTE: All reported adverse events were grade 1 or 2.

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Cancer Prevention Research: 11 (8)
August 2018
Volume 11, Issue 8
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Prospective Randomized Biomarker Study of Metformin and Lifestyle Intervention for Prevention in Obese Women at Increased Risk for Endometrial Cancer
Melinda S. Yates, Adriana M. Coletta, Qian Zhang, Rosemarie E. Schmandt, Meena Medepalli, Denise Nebgen, Beth Soletsky, Andrea Milbourne, Erma Levy, Bryan Fellman, Diana Urbauer, Ying Yuan, Russell R. Broaddus, Karen Basen-Engquist and Karen Lu
Cancer Prev Res August 1 2018 (11) (8) 477-490; DOI: 10.1158/1940-6207.CAPR-17-0398

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Prospective Randomized Biomarker Study of Metformin and Lifestyle Intervention for Prevention in Obese Women at Increased Risk for Endometrial Cancer
Melinda S. Yates, Adriana M. Coletta, Qian Zhang, Rosemarie E. Schmandt, Meena Medepalli, Denise Nebgen, Beth Soletsky, Andrea Milbourne, Erma Levy, Bryan Fellman, Diana Urbauer, Ying Yuan, Russell R. Broaddus, Karen Basen-Engquist and Karen Lu
Cancer Prev Res August 1 2018 (11) (8) 477-490; DOI: 10.1158/1940-6207.CAPR-17-0398
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