UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013804 |
|---|---|
| Receipt number | R000016115 |
| Scientific Title | Prospective evaluation of diabetes/ impaired glucose tolerance and insulin resistance among patients with endometrial cancer |
| Date of disclosure of the study information | 2014/04/25 |
| Last modified on | 2014/04/25 01:21:06 |
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Basic information
Public title
Prospective evaluation of diabetes/ impaired glucose tolerance and insulin resistance among patients with endometrial cancer
Acronym
Prospective evaluation of diabetes/ impaired glucose tolerance and insulin resistance among patients with endometrial cancer
Scientific Title
Prospective evaluation of diabetes/ impaired glucose tolerance and insulin resistance among patients with endometrial cancer
Scientific Title:Acronym
Prospective evaluation of diabetes/ impaired glucose tolerance and insulin resistance among patients with endometrial cancer
Region
| Japan |
Condition
Condition
Atypical endometrial hyperplasia
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the prevalence of obesity, insulin resistance and diabetes/ impaired glucose tolerance, among Japanese patients with atypical endometrial hyperplasia and endometrial cancer, as well as their associations with clinical characteristics
Basic objectives2
Others
Basic objectives -Others
epidemiologic study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the prevalence of obesity, insulin resistance and diabetes/ impaired glucose tolerance among Japanese patients with atypical endometrial hyperplasia and endometrial cancer
Key secondary outcomes
To evaluate the association with clinical characteristics and obesity,insulin resistance and diabetes/ impaired glucose tolerance
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
All patients, except those with a confirmed diagnosis of DM, underwent the 75-g oral glucose tolerance test
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
AEH and EC who received planned treatment at Chiba University Hospital.
The case that written informed consent was obtained before participation
Key exclusion criteria
Mental illness
Contraindication of glucose tolerance test
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Mitsuhashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Reproductive Medicine
Zip code
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 | |
| Middle name | |
| Last name | Akira Mitsuhashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Reproductive Medicine
Zip code
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
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 04 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 25 | Day |
Last modified on
| 2014 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016115
