UMIN-CTR Clinical Trial

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	https://pubmed.ncbi.nlm.nih.gov/31179612/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/31179612/
Number of participants that the trial has enrolled	49
Results	Impaired early-phase suppression of glucagon could be associated with the requirement for insulin treatment during pregnancy in patients with GDM.
Results date posted	2021 Year 04 Month 12 Day
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 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	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information	Impaired early-phase suppression of glucagon could be associated with the requirement for insulin treatment during pregnancy in patients with GDM.

Management information
Registered date	2018 Year 10 Month 01 Day
Last modified on	2021 Year 04 Month 12 Day

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