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
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
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
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
