UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059531 |
|---|---|
| Receipt number | R000068001 |
| Scientific Title | The Effect of a Remote-Supported Anti-Inflammatory Dietary Intervention on Glycemic Control from Pregnancy to the Postpartum Period in Women with Gestational and Pre-Existing Diabetes |
| Date of disclosure of the study information | 2025/10/31 |
| Last modified on | 2025/10/24 14:21:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Effect of a Remote-Supported Anti-Inflammatory Dietary Intervention on Glycemic Control from Pregnancy to the Postpartum Period in Women with Gestational and Pre-Existing Diabetes
Acronym
Remote-Supported Anti-Inflammatory Dietary Intervention and Glycemic Control in Pregnancy and Postpartum
Scientific Title
The Effect of a Remote-Supported Anti-Inflammatory Dietary Intervention on Glycemic Control from Pregnancy to the Postpartum Period in Women with Gestational and Pre-Existing Diabetes
Scientific Title:Acronym
Remote-Supported Anti-Inflammatory Dietary Intervention and Glycemic Control in Pregnancy and Postpartum
Region
| Japan |
Condition
Condition
Gestational diabetes mellitus (GDM), overt diabetes in pregnancy, type 1 diabetes (T1DM), and type 2 diabetes (T2DM)
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the impact of online-supported anti-inflammatory dietary counseling from pregnancy to the postpartum period on postpartum glycemic control and inflammatory/oxidative stress markers in women with gestational diabetes mellitus (GDM), overt diabetes in pregnancy, or pregnancies complicated by type 1 or type 2 diabetes (T1DM/T2DM).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of all women with prior GDM who meet both fasting plasma glucose <100 mg/dL and 2-hour plasma glucose <140 mg/dL on 75g-OGTT at 12 months postpartum.
Key secondary outcomes
To evaluate the effects of anti-inflammatory dietary intake on immune, inflammatory, and oxidative stress biomarkers.
Biomarkers include immune parameters (WBC, neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count), inflammatory stress markers (CRP, IL-6, hepcidin), and oxidative stress markers (8-OHdG).
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dietary Assessment and Nutrition Counseling Based on the Dietary Inflammatory Index (DII)
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1, Pregnant or postpartum women diagnosed with one of the following: gestational diabetes mellitus (GDM), overt diabetes first recognized during pregnancy, type diabetes mellitus (T1DM), or type 2 diabetes mellitus (T2DM)
2, Singleton pregnancy
3, Individuals expected to continue regular follow-up visits at the diabetes outpatient clinic.
4, Provided written informed consent of their own free will
Key exclusion criteria
Individuals not expected to attend regular follow-up visits.
Individuals who have difficulty communicating verbally or in writing in Japanese.
Individuals considered inappropriate for study participation by the principal investigator or co-investigators.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Ikuyo |
| Middle name | |
| Last name | HAYASHI |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute
Zip code
612-8555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
ikuyohayashi4119@gmail.com
Public contact
Name of contact person
| 1st name | Ikuyo |
| Middle name | |
| Last name | HAYASHI |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute
Zip code
612-8555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku
TEL
075-641-9161
Homepage URL
ikuyohayashi4119@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center, Clinical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
Tel
075-641-9161
404-j-doit1@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
--- Select One ---
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 31 | 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
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2030 | Year | 10 | 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
| 2025 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068001
