UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056347 |
|---|---|
| Receipt number | R000064275 |
| Scientific Title | An exploratory study of the effect of tofogliflozin on the glymphatic system |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2024/12/03 18:39:57 |
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Basic information
Public title
An exploratory study of the effect of tofogliflozin on the glymphatic system
Acronym
AEGIS
Scientific Title
An exploratory study of the effect of tofogliflozin on the glymphatic system
Scientific Title:Acronym
AEGIS
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate whether a 12-week treatment with tofogliflozin affects brain waste clearance indices (ALPS index, cerebral interstitial free water, perivascular space volume, gBOLD-CSF coupling, etc.), brain volume, and diffusion MRI quantitative values (diffusion tensor imaging [DTI], diffusion kurtosis imaging [DKI], neurite orientation dispersion and density imaging [NODDI], free-water imaging [FWI], etc.).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in cerebral waste clearance indexes by brain MRI
Key secondary outcomes
Changes in brain volume
Changes in diffusion MRI quantitative values
Percentage change of the following and correlation between the percentage change and each indicator
Cognitive function (MMSE, MoCA-J, Trail Making TesT)
Physiological examination (blood pressure, weight, body composition, etc.)
Blood test indices (HbA1c, glucose, lipids, liver function, etc.)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Diagnosed with type 2 diabetes.
2)Patients who have not reached the glycemic control targets specified in the Diabetes Treatment Guide 2024-2025, despite treatment with diet and exercise therapy or treatment with diabetes medications in addition to diet and exercise therapy for at least 3 months (12 weeks) and are scheduled to receive tofogliflozin hydrate tablets.
3)Patients who have not started a new or changed (increased) dose of any drug, including diabetes medications, for at least 8 weeks prior to obtaining consent.
4)The applicant's age at the time of obtaining consent is at least 18 years old and less than 80 years old.
5)Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
1.Type 1 diabetes or secondary diabetes.
2.Inferior glycemic control(HbA1c(NGSP) > 10%).
3.A history of cerebrovascular disease.
4.Dementia.
5.Severe hepatic dysfunction(100 IU/L < AST).
6.Moderate or severe heart failure (stage III or higher by NYHA/New York Heart Association classification).
7.Urinary tract or genital tract infections.
8.Pregnant, lactating, possibly pregnant or planning to become pregnant.
9.Malignant tumors or with a history of malignant tumors (however, those who have not received treatment for it and have no evidence of recurrence, and those who can be judged not to recur during the study period may be eligible).
10.Contraindications to tofogliflozin.
11.Other patients deemed by the physician to be inappropriate for inclusion in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Watada |
Organization
Graduate School of Medicine, Juntendo University
Division name
Department of Metabolism & Endocrinology
Zip code
113-0033
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03(3813)3111
hwatada@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hideyoshi |
| Middle name | |
| Last name | Kaga |
Organization
Graduate School of Medicine, Juntendo University
Division name
Department of Metabolism & Endocrinology
Zip code
113-0033
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03(3813)3111
Homepage URL
hkaga@juntendo.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Juntendo University
Institute
Department
Personal name
Hirotaka Watada
Funding Source
Organization
Kowa Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
igakubu.rinri1@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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | 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
| 2024 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 12 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064275
