UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057328 |
|---|---|
| Receipt number | R000063764 |
| Scientific Title | The effect of nutrition therapy on glycemic control in individuals with gestational diabetes mellitus |
| Date of disclosure of the study information | 2025/03/19 |
| Last modified on | 2025/03/19 10:25:24 |
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Basic information
Public title
The effect of dietitian-led nutrition therapy on glycemic control in individuals with gestational diabetes mellitus
Acronym
The effect of nutrition therapy on glycemic control in individuals with gestational diabetes mellitus
Scientific Title
The effect of nutrition therapy on glycemic control in individuals with gestational diabetes mellitus
Scientific Title:Acronym
The effect of nutrition therapy in individuals with gestational diabetes mellitus
Region
| Japan |
Condition
Condition
gestational diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to compare the blood glucose profile between the dietitian-led specific nutrition therapy in individuals with gestational diabetes mellitus.
Basic objectives2
Others
Basic objectives -Others
mean amplitude of glucose excursion
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
mean amplitude of glucose excursion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects wear continuous glucose monitoring devices and, on the test day, consume three main meals (breakfast, lunch, and dinner) at the specified times, in addition to two meals of carbohydrate at around 9:30 AM and 3:00 PM, totaling five meals per day. Each meal iss consumed in the following order: vegetables, side dishes, and carbohydrates, with each meal taking 15 minutes to complete.
Interventions/Control_2
The subjects wear continuous glucose monitoring devices and, on the test day, consumed the test meals in three separate sessions (breakfast, lunch, and dinner) at the specified times. The meals consisted of carbohydrates and side dishes, which is mixed in the mouth and consume within 15 minutes.
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Women with gestational diabetes mellitus
Those who have signed the consent form for this study
Those who have been deemed appropriate for participation in this study by the principal investigator
Key exclusion criteria
Patients with type 1 and type 2 diabetes
Insulin treated patients
Those who have been deemed inappropriate for participation in this study by the principal investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
Department of Food and Nutrition, Faculty of Home Economics
Zip code
6058501
Address
35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto
TEL
0755317128
imais@kyoto-wu.ac.jp
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
Department of Food and Nutrition
Zip code
6058501
Address
35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto
TEL
0755317128
Homepage URL
imais@kyoto-wu.ac.jp
Sponsor or person
Institute
Kyoto Women's University
Institute
Department
Personal name
Funding Source
Organization
JSPS (Japan Society for the Promotion of Science) KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Women's University
Address
35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto
Tel
0755317128
imais@kyoto-wu.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
梶山内科クリニック
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063764
