UMIN-CTR Clinical Trial

Basic information
Public title	Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Acronym	Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Scientific Title	Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Scientific Title:Acronym	Predictive factors during the postpartum period for glucose intolerance in women with 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 investigate the risk factors for glucose intolerance in women with GDM.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study was to investigate the predictive factor during the postpartum period for glucose intolerance in women with GDM at a singles perinatal center in Japan by comparing the various factors between the patients with normal glucose tolerance and glucose intolerance.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The risk factors for glucose intolerance in women with GDM during the postpartum period
Key secondary outcomes	1) Patient's basic information: age, pre-pregnancy BMI, and previous pregnancy 2) Gestational history of pregnancy and delivery: 75 g OGTT results, weight gain, number of days in pregnancy, maternal perinatal complications 3) Clinical information on the child: child weight, neonatal complications, and Apgar score 4) Treatment: insulin unit count 5) Postpartum information: postpartum 75gOGTT results 6) Patient's medical record information: Family history of diabetes

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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who were diagnosed with GDM between January 1 2015 and May 31 2020 at Yokohama Medical Center, and who had glucose tolerance test within postpartum period.
Key exclusion criteria	Patients were excluded if they had; no measurement for insulin at the postpartum OGTT, been treated with steroid, or overt diabetes.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Kazuki Middle name Last name Tajima
Organization	Yokohama Medical Center
Division name	Department of endocrinology & metabolism
Zip code	245-8575
Address	3-60-2 Harajuku, Totsuka-ku, Yokohama
TEL	045-851-2621
Email	tajima.kazuki.jn@mail.hosp.go.jp

Public contact
Name of contact person	1st name Kazuki Middle name Last name Tajima
Organization	Yokohama Medical Center
Division name	Department of endocrinology & metabolism
Zip code	245-8575
Address	3-60-2 Harajuku, Totsuka-ku, Yokohama
TEL	045-851-2621
Homepage URL
Email	tajima.kazuki.jn@mail.hosp.go.jp

Sponsor
Institute	Yokohama Medical Center
Institute
Department

Funding Source
Organization	This research will be funded by the basic research funds of the department to which the principal investigator belongs.
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	Yokohama Medical Center, Clinical Trial Management Office
Address	3-60-2 Harajuku, Totsuka-ku, Yokohama
Tel	045-851-2621
Email	700-kenkyu@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 25 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	2020 Year 09 Month 02 Day
Date of IRB	2020 Year 09 Month 02 Day
Anticipated trial start date	2020 Year 12 Month 26 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a retrospective observational study using existing medical record information from routine practice, and no burden or risk is expected to arise from participation in this study. The results of the study may be beneficial for future advances in the management of gestational diabetes mellitus.

Management information
Registered date	2020 Year 12 Month 24 Day
Last modified on	2020 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048874