UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037997 |
|---|---|
| Receipt number | 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 11:13:27 |
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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
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
k2igarashi@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043313
