UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062207 |
|---|---|
| Receipt number | R000070168 |
| Scientific Title | Menstrual Cycle-Related Changes in Insulin Sensitivity in Premenopausal Women with Type 1 Diabetes |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/10 18:05:46 |
* 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
Menstrual Cycle-Related Changes in Insulin Sensitivity in Premenopausal Women with Type 1 Diabetes
Acronym
Menstrual Cycle-Related Changes in Insulin Sensitivity in Premenopausal Women with Type 1 Diabetes
Scientific Title
Menstrual Cycle-Related Changes in Insulin Sensitivity in Premenopausal Women with Type 1 Diabetes
Scientific Title:Acronym
Menstrual Cycle-Related Changes in Insulin Sensitivity in Premenopausal Women with Type 1 Diabetes
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize women with type 1 diabetes who exhibit a luteal phase-associated decline in insulin sensitivity and to elucidate the organ-specific mechanisms underlying this phenomenon, including alterations in insulin clearance
Basic objectives2
Others
Basic objectives -Others
Physiological Assessment of Menstrual Cycle-Related Organ-Specific Changes in Insulin Sensitivity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Menstrual Cycle-Related Changes in Skeletal Muscle Insulin Sensitivity
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Premenopausal women diagnosed with type 1 diabetes
2) Patients receiving treatment with the MiniMed 780G advanced hybrid closed-loop system
3) Patients who are 18 years of age or older at the time of informed consent who have not reached menopause
4) Patients with regular menstrual cycles
5) Patients who, after receiving a sufficient explanation of the study and fully understanding its contents, provide written informed consent to participate of their own free will
Key exclusion criteria
1) Patients with type 2 diabetes or secondary diabetes
2) Patients with extremely poor glycemic control, defined as an HbA1c (NGSP) level of 10% or higher
3) Patients not receiving treatment with the MiniMed 780G advanced hybrid closed-loop system
4) Patients who are pregnant, breastfeeding, possibly pregnant, or planning pregnancy
5) Patients receiving hormonal contraception or hormone therapy
6) Patients receiving glucocorticoid therapy
7) Patients with systemic diseases that may affect glycemic profiles
8) Patients considered unsuitable for participation in the study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideyoshi |
| Middle name | |
| Last name | Kaga |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku,Tokyo, Japan.
TEL
03-3811-3111
hkaga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hideyoshi |
| Middle name | |
| Last name | Kaga |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku,Tokyo, Japan.
TEL
03-3811-3111
Homepage URL
hkaga@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Manpei suzuki diabetes foundantion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku,Tokyo, Japan.
Tel
03-5802-1584
hongo-rinri@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 10 | 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
| 2026 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To characterize women with type 1 diabetes who exhibit a luteal phase-associated decline in insulin sensitivity and to elucidate the organ-specific mechanisms underlying this phenomenon, including alterations in insulin clearance
Management information
Registered date
| 2026 | Year | 07 | Month | 10 | Day |
Last modified on
| 2026 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070168
