UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013804
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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
Email 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
Email antira@faculty.chbia-u.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.