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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022665
Receipt No. 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

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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 Obsterics 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
Email 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
Email hamaihashimototakuya@yahoo.co.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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