UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059974 |
|---|---|
| Receipt number | R000068586 |
| Scientific Title | Misleading Islet Markers in Cases Treated with Immunoglobulin Therapy |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/04 15:47:09 |
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Basic information
Public title
Misleading Islet Markers in Cases Treated with Immunoglobulin Therapy
Acronym
Misleading Islet Markers in Cases Treated with Immunoglobulin Therapy
Scientific Title
Misleading Islet Markers in Cases Treated with Immunoglobulin Therapy
Scientific Title:Acronym
MIMIC-Ig
Region
| Japan |
Condition
Condition
Diseases treated with immunoglobulin therapy, such as myasthenia gravis and idiopathic thrombocytopenic purpura
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the proportion of patients who become positive for islet-related autoantibodies after immunoglobulin administration by measuring islet-related autoantibodies (GAD antibody, IA-2 antibody, insulin antibody, and ZnT8 antibody) before and after immunoglobulin therapy.
Another purpose is to determine how long it takes for patients who become positive for islet-related autoantibodies to become negative.
Basic objectives2
Others
Basic objectives -Others
Biomarker Kinetics and Incidence Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of patients who seroconvert to positive for one or more islet-associated autoantibodies (GAD antibody, IA-2 antibody, insulin antibody, and ZnT8 antibody) after immunoglobulin therapy (IVIg).
Key secondary outcomes
1) The time it takes for islet-associated autoantibodies to become negative again in patients who became positive after receiving immunoglobulin.
2) The incidence 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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who are scheduled to receive immunoglobulin therapy for diseases such as myasthenia gravis and idiopathic thrombocytopenic purpura.
2) Patients who have received a full explanation of and fully understood the details of participating in this study and have voluntarily provided written consent.
Key exclusion criteria
Patients who meet any of the following criteria are ineligible to participate in this study.
1) Patients who have received immunoglobulin therapy within the past six months.
2) Patients who have been diagnosed with diabetes.
3) Patients with one or more of the following: HbA1c 6.5% or higher, fasting blood glucose 126 mg/dL or higher, or casual blood glucose 200 mg/dL or higher.
4) Patients who tested positive for islet-associated autoantibodies (GAD antibody, IA-2 antibody, insulin antibody, ZnT8 antibody) before starting immunoglobulin therapy.
5) Patients who may discontinue outpatient treatment at our hospital due to reasons such as transferring to another hospital or moving within three months of obtaining consent.
6) Patients who are deemed unsuitable for the safe implementation of this study by the principal investigator or co-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Jin |
| Middle name | |
| Last name | Kumagai |
Organization
Chiba University Hospital
Division name
Department of Diabetes, Metabolism and Endocrinology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku,Chiba, JAPAN
TEL
043-226-2092
kumaj@chiba-u.jp
Public contact
Name of contact person
| 1st name | Jin |
| Middle name | |
| Last name | Kumagai |
Organization
Chiba University Hospital
Division name
Department of Diabetes, Metabolism and Endocrinology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku,Chiba, JAPAN
TEL
043-226-2092
Homepage URL
kumaj@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Clinical Research Center
Address
1-8-1 Inohana, Chuo-ku,Chiba, JAPAN
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 01 | 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 | 11 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 06 | Month | 30 | Day |
Other
Other related information
(1) Prospective observational study
(2) Observation and test items
Age, sex, height, weight, lifestyle (e.g., drinking, smoking), employment history, medical history, concomitant medications, family history, type of immunoglobulin therapy, dosage, and frequency of administration
Clinical test results (including biochemistry, hematology, and urinalysis)
GAD antibody, IA-2 antibody, insulin antibody, ZnT8 antibody, blood glucose level, HbA1c, CPR, IRI
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068586
