UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007359 |
|---|---|
| Receipt number | R000008358 |
| Scientific Title | Incretin response in patients with idiopathic reactive hypoglycemia |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2017/03/15 19:08:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Incretin response in patients with idiopathic reactive hypoglycemia
Acronym
Incretin response in idiopathic reactive hypoglycemia
Scientific Title
Incretin response in patients with idiopathic reactive hypoglycemia
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hitoshi Shimano |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Division of Endocrinology and Metabolism, Department of Internal medicine
Zip code
Address
1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3053
hsimano@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Suzuki |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Division of Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3053
Homepage URL
hirosuzu@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
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)
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
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 |
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
Terminated
Date of protocol fixation
| 2012 | Year | 02 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008358
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
