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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034337
Receipt No. R000038940
Scientific Title Evaluation of glucagon secretion during 75g-OGTT to predict requirement of insulin therapy, perinatal outcome, and development of type 2 diabetes after delivery in Japanese patients with gestational diabetes.
Date of disclosure of the study information 2018/10/01
Last modified on 2019/04/09

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Basic information
Public title Evaluation of glucagon secretion during 75g-OGTT to predict requirement of insulin therapy, perinatal outcome, and development of type 2 diabetes after delivery in Japanese patients with gestational diabetes.
Acronym Glucagon secretion in GDM
Scientific Title Evaluation of glucagon secretion during 75g-OGTT to predict requirement of insulin therapy, perinatal outcome, and development of type 2 diabetes after delivery in Japanese patients with gestational diabetes.
Scientific Title:Acronym Glucagon secretion in GDM
Region
Japan

Condition
Condition Gestational diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The prevalence of gestational diabetes mellitus (GDM) has recently increased all over the world after adoption of the International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria in 2010. It has been reported that 12 % of all the pregnant women develop GDM in Japan and one third of the patients require insulin treatment. Although the GDM patients who are complicated with obesity before pregnancy and/or severe glucose intolerance are more likely to require insulin therapy, there are no useful markers to predict the requirement of insulin therapy during pregnancy, and development of type 2 diabetes after delivery. This study was aimed to evaluate the predictive value of beta- and alpha-cell functions after glucose load in the patients with GDM.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Insulin requirement during pregnancy
Key secondary outcomes Perinatal mortality.
Development of type 2 diabetes after delivery.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
50 years-old >=
Gender Female
Key inclusion criteria Pregnant women diagnosed with gestational diabetes defined by IADPSG criteria during pregnancy.
Key exclusion criteria Type 1 diabetes.
Type 2 diabetes.
GDM who had been treated with insulin before enrollment of the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Horie
Organization Nagasaki University
Division name Department of Endocrinology and Metabolism
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7200
Email holy197741@me.com

Public contact
Name of contact person
1st name Ichiro
Middle name
Last name Horie
Organization Nagasaki University
Division name Department of Endocrinology and Metabolism
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7200
Homepage URL
Email holy197741@me.com

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
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 Nagasaki University Hospital Clinical Study Review Board
Address 1-7-1 Sakamoto, Nagasaki
Tel 095-819-7200
Email holy197741@me.com

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
2018 Year 10 Month 01 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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 31 Day
Date of IRB
2014 Year 03 Month 31 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information On going

Management information
Registered date
2018 Year 10 Month 01 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038940

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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