UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025917 |
|---|---|
| Receipt number | R000029805 |
| Scientific Title | Studies on clinical features and mechanisms of hypoglycemia in non-islet cell tumor hypoglycemia |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2017/01/31 10:54:43 |
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Basic information
Public title
Studies on clinical features and mechanisms of hypoglycemia in non-islet cell tumor hypoglycemia
Acronym
clinical features of hypoglycemia in non-islet cell tumor hypoglycemia
Scientific Title
Studies on clinical features and mechanisms of hypoglycemia in non-islet cell tumor hypoglycemia
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sugihara |
Organization
Nippon Medical School Hospital
Division name
Department of Endocrinology,Diabetes and Metabolism
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
hitoshi@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Izumi Fukuda |
Organization
Nippon Medical School Hospital
Division name
Department of Endocrinology,Diabetes and Metabolism
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
Homepage URL
i-fukuda@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029805
