UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022665 |
|---|---|
| Receipt number | R000026126 |
| Scientific Title | Observational study to assess the Ensure-based prediction of women with gestational diabetes mellitus who need insulin therapy |
| Date of disclosure of the study information | 2016/06/08 |
| Last modified on | 2016/06/08 16:30:57 |
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Basic information
Public title
Observational study to assess the Ensure-based prediction of women with gestational diabetes mellitus who need insulin therapy
Acronym
Study to assess the Ensure-based prediction of women with gestational diabetes mellitus who need insulin therapy
Scientific Title
Observational study to assess the Ensure-based prediction of women with gestational diabetes mellitus who need insulin therapy
Scientific Title:Acronym
Study to assess the Ensure-based prediction of women with gestational diabetes mellitus who need insulin therapy
Region
| Japan |
Condition
Condition
Gestational Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether Ensure-load predicts need for insulin therapy in women with gestational diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between values such as plasma glucose, insulin, and C peptide after Ensure-load and self-monitoring of blood glucose
Key secondary outcomes
To establish the cut-off point during Ensure-loading test which can detect women with gestational diabetes mellitus who need insulin therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
500 ml of oral Ensure Liquid (500 kcal)
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Women with gestational diabetes mellitus
Key exclusion criteria
The women who have diabetes before pregnancy; have overt diabetes during pregnancy; use the drug affecting blood glucose; have GAD65 antibody
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morita |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1, Handayama, Higasi-ku Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL
053-435-2263
moritahr@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Hashimoto |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1, Handayama, Higasi-ku Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL
053-435-2263
Homepage URL
hamaihashimototakuya@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
| 2016 | Year | 06 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | 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
Management information
Registered date
| 2016 | Year | 06 | Month | 08 | Day |
Last modified on
| 2016 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026126
