UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015470
Receipt number R000017984
Scientific Title Effect of metformin on the endometrium of obese, insulin-resistant women
Date of disclosure of the study information 2014/10/20
Last modified on 2019/04/23 09:20:28

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Basic information

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

obese, insulin-resistant women

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study will investigate the antiproliferative effects of metformin on the endometrium of obese, insulin-resistant women. The changes in serum levels of insulin, insulin-like growth factor-1 (IGF-1), adipocytokines (leptin and adiponectin); body mass index (BMI); and insulin resistance will be evaluated after metformin intake.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate the effect of metformin on phospho-ERK expression in the endometrium

Key secondary outcomes

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.



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

45 years-old >=

Gender

Female

Key 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

Key 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

Target sample size

15


Research contact person

Name of lead principal investigator

1st name AKIRA
Middle name
Last name Mitsuhashi

Organization

Graduate School of Medicine, Chiba University,

Division name

Reproductive Medicine

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan

TEL

043-222-7171

Email

antira@faculty.chiba-u.jp


Public contact

Name of contact person

1st name AKIRA
Middle name
Last name Mitsuhashi

Organization

Graduate School of Medicine, Chiba University

Division name

Reproductive Medicine

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan

TEL

043-222-7171

Homepage URL


Email

antira@faculty.chbia-u.jp


Sponsor or person

Institute

Graduate School of Medicine, Chiba University

Institute

Department

Personal name



Funding Source

Organization

The Japan Society for Promotion
of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Hospital

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan

Tel

043-222-7171

Email

hanaoka.hideki@faculty.chiba-u.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 10 Month 14 Day

Date of IRB

2014 Year 10 Month 14 Day

Anticipated trial start date

2014 Year 10 Month 20 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 19 Day

Last modified on

2019 Year 04 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017984


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name