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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037997
Receipt No. R000043313
Scientific Title Effect of mailed outreach invitation for a 75 g oral glucose tolerance test in women with previous gestational diabetes
Date of disclosure of the study information 2020/01/01
Last modified on 2019/09/12

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Basic information
Public title Effect of mailed outreach invitation for a 75 g oral glucose tolerance test in women with previous gestational diabetes
Acronym Effect of mailed outreach invitation for a 75 g oral glucose tolerance test in women with previous gestational diabetes
Scientific Title Effect of mailed outreach invitation for a 75 g oral glucose tolerance test in women with previous gestational diabetes
Scientific Title:Acronym Effect of mailed outreach invitation for a 75 g oral glucose tolerance test in women with previous gestational diabetes
Region
Japan

Condition
Condition Gestational diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether mailing a letter for outreach invitation to women with a history of gestational diabetes is become a recommendation for a 75 g oral glucose tolerance test as a postpartum glucose tolerance assessment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of women achieving a 75 g OGTT
Key secondary outcomes 1. Proportion of a 75 g OGTT abnormal (Borderline type or diabetic type).
75gOGTT results are based on diabetes diagnostic criteria,
(i) Diabetic type: fasting plasma glucose level of more than 126 mg/dl or 2-h value of more than 200 mg/dl in 75gOGTT.
(ii)Normal type; fasting plasma glucose level of<110 mg/dl and 2-h value of<140mg/dl in OGTT.
(iii) Borderline type (neither diabetic nor normal type); falling between the diabetic and normal values.
2.Comparison of AUC-glucose, AUC-IRI, HOMA-IR, and Insulinogenic index during the OGTT calculated at 3 months after delivery.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 Mail a letter for outreach invitation to women with a history of gestational diabetes and perform a 75 g OGTT to the applicants.
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 Female
Key inclusion criteria Inclusion criteria:
1. Women with a history of GDM who underwent glycemic control during the pregnancy in our hospital
2. Normal glucose tolerance was confirmed by a 75 g OGTT at 3 months after delivery
3. More than one year after delivery
4. No appointment for the next visit
Key exclusion criteria Exclusion criteria:
1. Chronic or severe illnesses that the investigator judges to be difficult to perform
2. During pregnancy
3. Having already been diagnosed with diabetes
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasushi
Middle name
Last name Tanaka
Organization St.Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology,Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao,Miyamae-ku,Kawasaki,Kanagawa 216-8511,Japan
TEL 0449778111
Email smu.tainai@gmail.com

Public contact
Name of contact person
1st name Kana
Middle name
Last name Igarashi
Organization St.Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology,Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao,Miyamae-ku,Kawasaki,Kanagawa 216-8511,Japan
TEL 0449778111
Homepage URL
Email k2igarashi@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization St.Marianna University School of Medicine
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 Institutional Review Board,St.Marianna University School of Medicine
Address 2-16-1 Sugao,Miyamae-ku,Kawasaki,Kanagawa 216-8511,Japan
Tel 0449778111
Email k-sienbu.mail@marianna-u.ac.jp

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 聖マリアンナ医科大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 01 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 09 Month 24 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 09 Month 12 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043313

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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