UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Incretin response in patients with idiopathic reactive hypoglycemia
Title of the study (Brief title)	Incretin response in idiopathic reactive hypoglycemia
Region	Japan

Condition
Condition	idiopathic reactive hypoglycemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate incretin response in patients with idiopathic reactive hypoglycemia.
Basic objectives2	Others
Basic objectives -Others	To investigate incretin response after 75g oral glucose tolerance test.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Area under the curve of plasma GLP-1 level after 75g oral glucose tolerance test
Key secondary outcomes	Areas under the curve of plasma levels of gulcagon, GIP, glucose and serum insulin concentration

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Idiopathic reactive hypoglycemia
Interventions/Control_2	Normal Control
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients group, idiopathic reactive hypoglycemia Normal control
Key exclusion criteria	1. Age < 20 years old 2. Hb <12.0g/dl (male) or <11.0g/dl (female) 3. Other condition
Target sample size	15

Research contact person
Name of lead principal investigator	Hitoshi Shimano
Organization	Faculty of Medicine, University of Tsukuba
Division name	Division of Endocrinology and Metabolism, Department of Internal medicine
Address	1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3053
Email	hsimano@md.tsukuba.ac.jp

Public contact
Name of contact person	Hiroaki Suzuki
Organization	Faculty of Medicine, University of Tsukuba
Division name	Division of Endocrinology and Metabolism, Department of Internal Medicine
Address	1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3053
Homepage URL
Email	hirosuzu@md.tsukuba.ac.jp

Sponsor
Institute	Department of Endocrinology and Metabolism, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Pediatrics, Faculty of Medicine, University of Tsukuba
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	筑波大学附属病院（茨城県）

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 02 Month 20 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date
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

Management information
Registered date	2012 Year 02 Month 22 Day
Last modified on	2017 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008358