UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on clinical features and mechanisms of hypoglycemia in non-islet cell tumor hypoglycemia
Title of the study (Brief title)	clinical features of hypoglycemia in non-islet cell tumor hypoglycemia
Region	Japan

Condition
Condition	Insulin-like growth factor-II producing non-islet cell tumor hypoglycemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The pathogenesis of NICTH is thought to be an excessive production by tumors of big IGF-II. Confirmation of big IGF-II in the circulation is important for diagnosing IGF-II producing NICTH. In this study, we investigated whether the profile of glucose-regulatory hormones is helpful for identifying patients with hypoglycemia who need molecular weight analysis of IGF-II.
Basic objectives2	Others
Basic objectives -Others	This study investigated the levels of glucose-regulatory hormones in patients with NICTH with high serum levels of big IGF-II (big IGF-II group) and compared these with profiles of patients with spontaneous hypoglycemia with normal IGF-II levels (normal IGF-II group).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clarification of the characteristics of glucose-regulatory hormone profiles (insulin, GH, IGF-I, ACTH, cortisol) in patients with IGF-II producing NICTH.
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases of a spontaneous hypoglycemia, whose serum samples were sent to the Nippon Medical School from multiple Japanese facilities for the purpose of diagnosis of IGF-II producing tumor after 2015.
Key exclusion criteria	Patients who lacked sufficient medical information for analysis of glucose-regulatory hormone profiles.
Target sample size	28

Research contact person
Name of lead principal investigator	Hitoshi Sugihara
Organization	Nippon Medical School Hospital
Division name	Department of Endocrinology,Diabetes and Metabolism
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL	03-3822-2131
Email	hitoshi@nms.ac.jp

Public contact
Name of contact person	Izumi Fukuda
Organization	Nippon Medical School Hospital
Division name	Department of Endocrinology,Diabetes and Metabolism
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL	03-3822-2131
Homepage URL
Email	i-fukuda@nms.ac.jp

Sponsor
Institute	Nippon Medical School Hospital
Institute
Department

Funding Source
Organization	Nippon Medical School Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 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	Retrospective study

Management information
Registered date	2017 Year 01 Month 31 Day
Last modified on	2017 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029805