UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for investigating the secretion of incretin and glucagon in pregnant women with gestational diabetes mellitus
Title of the study (Brief title)	Study for investigating the secretion of incretin and glucagon in pregnant women with gestational diabetes mellitus
Region	Japan

Condition
Condition	Gestational Diabetes Mellitus
Classification by specialty	Endocrinology and Metabolism Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the secretion of GLP-1, GIP, and glucagon in pregnant women with gestational diabetes mellitus
Basic objectives2	Others
Basic objectives -Others	To assess the secretion of endogenic hormone in vivo
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The secretion of incretin, and glucagon during 75g oral glucose tolerance test
Key secondary outcomes	Identification of risk factor of gestational diabetes mellitus that needs insulin therapy or not

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	The pregnant woman with 24 to 30 weeks of gestational age who are scheduled 75g oral glucose tolerance test
Key exclusion criteria	The woman who has diabetes before pregnancy; has overt diabetes during pregnancy; uses the drug affecting blood glucose; has GAD65 antibody
Target sample size	250

Research contact person
Name of lead principal investigator	Hiroshi Morita
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1, Handayama, Higasi-ku Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL	053-435-2263
Email	moritahr@hama-med.ac.jp

Public contact
Name of contact person	Takuya Hashimoto
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1, Handayama, Higasi-ku Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL	053-435-2263
Homepage URL
Email	hamaihashimototakuya@yahoo.co.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	浜松医科大学医学部附属病院（静岡県）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 04 Month 23 Day
Anticipated trial start date	2013 Year 04 Month 23 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To assess the secretion of incretin, glucagon, and somatostatin during 75g oral glucose tolerance test in pregnant women with gestational diabetes mellitus

Management information
Registered date	2013 Year 04 Month 23 Day
Last modified on	2016 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012366