Effect of metformin on the endometrium of obese, insulin-resistant women

Effect of metformin on the endometrium of obese, insulin-resistant women - Effect of metformin on the endometrium of obese, insulin-resistant women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015470

Enrollment

Registered

2014-10-20

Start date

2014-10-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obese, insulin-resistant women

Interventions

1) Patients will receive a daily dose of metformin (initial dose, 500 mg/day

increasing, weekly, up to 1500 mg/day, in the absence of adverse effects) for 3 months 2) Blood samples and endometrial biopsies will be obtained at baseline and after 3 months.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Normal endometrium or simple hyperplasia, without atypia. 2. BMI 25 and over and a positive test for insulin resistance 3. Menstrual irregularity 4. Aged between 20- and 45-years-old 5. Eastern Cooperative Oncology Group Performance status 0 6. Provided written informed consent

Exclusion criteria

Exclusion criteria: 1. Prior medical history of chemical sensitivity to metformin 2. Women desiring to become pregnant during the study period 3. Serum creatinine level >1.0 mg/dL 4. History of lactic acidosis 5. Requiring dialysis 6. Shock, cardiac arrest, cardiac infarction, pulmonary thrombosis, or severe cardiovascular and/or lung damage 7. Ingestion of excessive amounts of alcohol 8. Liver dysfunction 9. History of thrombosis 10. Mental illness that may require antipsychotic therapy 11. Diabetes mellitus requiring medication 12. Concomitant malignancies 13. Ineligible, as determined by the physician-in-charge for any other reason

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of metformin on phospho-ERK expression in the endometrium	—

Secondary

Measure	Time frame
1. To evaluate the effect of metformin on biomarker expression in the endometrium. Differences in Ki-67 and topoisomeraseIIa; expression will be assessed immunohistochemically.Phospho-AKT, phospho-AMPK, phospho-rpS6, cyclin D1, pRB, and p27 will be assessed using western blot analysis. 2. To evaluate the effect of metformin on serum biomarkers, such as insulin, IGF-1, and adipocytokines, such as leptin and adiponectin. 3. To evaluate the changes in BMI and insulin resistance after metformin treatment. 4. To evaluate the changes in the growth-stimulatory potential of sera after metformin treatment.	—

Measure

Time frame

1. To evaluate the effect of metformin on biomarker expression in the endometrium. Differences in Ki-67 and topoisomeraseIIa; expression will be assessed immunohistochemically.Phospho-AKT, phospho-AMPK, phospho-rpS6, cyclin D1, pRB, and p27 will be assessed using western blot analysis. 2. To evaluate the effect of metformin on serum biomarkers, such as insulin, IGF-1, and adipocytokines, such as leptin and adiponectin. 3. To evaluate the changes in BMI and insulin resistance after metformin treatment. 4. To evaluate the changes in the growth-stimulatory potential of sera after metformin treatment.

—

Countries

Japan

Contacts

Public ContactAKIRA Mitsuhashi

Graduate School of Medicine, Chiba University Reproductive Medicine

antira@faculty.chbia-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026