UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061447 |
|---|---|
| Receipt number | R000070212 |
| Scientific Title | A retrospective study of clinical characteristics and therapeutic interventions in patients with GAD antibody-positive diabetes |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/04/26 23:40:19 |
* 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
A retrospective study of clinical characteristics and therapeutic interventions in patients with GAD antibody-positive diabetes
Acronym
GAD-CARE Study
Scientific Title
A retrospective study of clinical characteristics and therapeutic interventions in patients with GAD antibody-positive diabetes
Scientific Title:Acronym
GAD-CARE Study
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with diabetes who are positive for anti-GAD antibodies, pancreatic B-cells are gradually destroyed, leading to impaired insulin secretion. Therefore, in determining treatment strategies, it is important to consider B-cell-preserving therapies and the use of intensive insulin therapy.
In recent years, advances in research on the pathogenesis of type 1 diabetes have led to the proposal of a staging classification based on islet autoantibodies, including anti-GAD antibodies, and glycemic indices. This framework highlights the importance of earlier intervention.
Stage 1: Presence of two or more autoantibodies with normoglycemia
Stage 2: Presence of one or more autoantibodies with dysglycemia (asymptomatic)
Stage 3: Overt diabetes with hyperglycemia; autoantibodies may become negative over time
In Japan, under the national health insurance system, measurement of autoantibodies is reimbursed only at Stage 3. At our hospital, anti-GAD antibodies have been measured in all patients at their initial visit as part of screening for type 1 diabetes, and the results have been utilized in determining treatment strategies.
In this study, we retrospectively analyzed the clinical data accumulated at our hospital with the aim of clarifying the following three points:
1. The prevalence of anti-GAD antibody-positive patients
2. Clinical characteristics of anti-GAD antibody-positive patients (including complications)
3. Treatment interventions implemented in anti-GAD antibody-positive patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of anti-GAD antibody-positive patients
Key secondary outcomes
Clinical characteristics of anti-GAD antibody-positive patients (including complications)
Treatment interventions implemented in anti-GAD antibody-positive
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients tested for anti-GAD antibodies at our hospital were included. Because the measurement method and reference range for anti-GAD antibodies were changed in December 2015, the study period was defined as the 10 years from January 2016 to December 2025.
Key exclusion criteria
None.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-0822
Address
1010, Sakurai, Kisarazu, Chiba
TEL
0438-36-1071
ishibashi-cib@umin.net
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Kondo |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-0822
Address
1010, Sakurai, Kisarazu, Chiba
TEL
0438-36-1071
Homepage URL
hiroya.k0526@gmail.com
Sponsor or person
Institute
Kimitsu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kimitsu Chuo Hospital
Address
1010, Sakurai, Kisarazu, Chiba
Tel
0438-36-1071
hiroya.k0526@gmail.com
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 | 05 | Month | 11 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Prevalence of anti-GAD antibody positivity
The prevalence was calculated as the number of anti-GAD antibody-positive patients divided by the total number of patients tested for anti-GAD antibodies, and temporal trends were evaluated.
2. Clinical characteristics of anti-GAD antibody-positive patients
Duration of diabetes and treatment history (including insulin, oral hypoglycemic agents, and GLP-1 receptor agonists)
Family history (particularly type 1 diabetes)
Physical findings
Diabetic complications
Comorbidities
Laboratory data, including hematology, biochemistry, immunology, and urinalysis
Required parameters: blood glucose, HbA1c, insulin, and C-peptide (CPR)
3. Treatment interventions in anti-GAD antibody-positive patients
Insulin, GLP-1 receptor agonists, and oral hypoglycemic agents
In patients who were continuously followed at our hospital, longitudinal changes in treatment history were evaluated
4. Characteristics of anti-GAD antibody-negative patients
Data corresponding to items 2 and 3 were collected for anti-GAD antibody-negative patients and compared with those of anti-GAD antibody-positive patients.
Management information
Registered date
| 2026 | Year | 05 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070212
