UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034337 |
|---|---|
| Receipt number | R000038940 |
| Scientific Title | Evaluation of glucagon secretion during 75g-OGTT to predict requirement of insulin therapy, perinatal outcome, and development of type 2 diabetes after delivery in Japanese patients with gestational diabetes. |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/04/12 20:12:55 |
* 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
Evaluation of glucagon secretion during 75g-OGTT to predict requirement of insulin therapy, perinatal outcome, and development of type 2 diabetes after delivery in Japanese patients with gestational diabetes.
Acronym
Glucagon secretion in GDM
Scientific Title
Evaluation of glucagon secretion during 75g-OGTT to predict requirement of insulin therapy, perinatal outcome, and development of type 2 diabetes after delivery in Japanese patients with gestational diabetes.
Scientific Title:Acronym
Glucagon secretion in GDM
Region
| Japan |
Condition
Condition
Gestational diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prevalence of gestational diabetes mellitus (GDM) has recently increased all over the world after adoption of the International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria in 2010. It has been reported that 12 % of all the pregnant women develop GDM in Japan and one third of the patients require insulin treatment. Although the GDM patients who are complicated with obesity before pregnancy and/or severe glucose intolerance are more likely to require insulin therapy, there are no useful markers to predict the requirement of insulin therapy during pregnancy, and development of type 2 diabetes after delivery. This study was aimed to evaluate the predictive value of beta- and alpha-cell functions after glucose load in the patients with GDM.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Insulin requirement during pregnancy
Key secondary outcomes
Perinatal mortality.
Development of type 2 diabetes after delivery.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant women diagnosed with gestational diabetes defined by IADPSG criteria during pregnancy.
Key exclusion criteria
Type 1 diabetes.
Type 2 diabetes.
GDM who had been treated with insulin before enrollment of the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University
Division name
Department of Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7200
holy197741@me.com
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University
Division name
Department of Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7200
Homepage URL
holy197741@me.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Study Review Board
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7200
holy197741@me.com
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
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31179612/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31179612/
Number of participants that the trial has enrolled
49
Results
Impaired early-phase suppression of glucagon could be associated with the requirement for insulin treatment during pregnancy in patients with GDM.
Results date posted
| 2021 | Year | 04 | Month | 12 | Day |
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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Impaired early-phase suppression of glucagon could be associated with the requirement for insulin treatment during pregnancy in patients with GDM.
Management information
Registered date
| 2018 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
