UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000055318
Receipt number	R000062861
Scientific Title	An observational study: Prevalence of Pre-symptomatic Type 1 Diabetes in first-degree relatives in Japan
Date of disclosure of the study information	2024/08/23
Last modified on	2025/09/03 11:11:53

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Basic information

Public title

An observational study: Prevalence of Pre-symptomatic Type 1 Diabetes in first-degree relatives in Japan

Acronym

PREP-T1D

Scientific Title

An observational study: Prevalence of Pre-symptomatic Type 1 Diabetes in first-degree relatives in Japan

Scientific Title:Acronym

An observational study: Prevalence of Pre-symptomatic Type 1 Diabetes in first-degree relatives in Japan

Region

Japan

Condition

First-degree relatives of people with acute-onset type 1 diabetes.

Classification by specialty

Endocrinology and Metabolism Adult Child

Classification by malignancy

Others

Genomic information

YES

Objectives

Narrative objectives1

To identify individuals with the pathogenesis comparable to Stage 1 and 2 type 1 diabetes in first-degree relatives of people with acute-onset type 1 diabetes in Japan and evaluate the prevalence among them.

Basic objectives2

Others

Basic objectives -Others

The proportion of individuals who are positive for islet autoantibodies and have or do not have glucose metabolism disorders among first-degree relatives of people with acute-onset type 1 diabetes.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Assessment

Primary outcomes

The proportion of individuals who are positive for islet autoantibodies and have or do not have glucose metabolism disorders among first-degree relatives of people with acute-onset type 1 diabetes or slowly progressive insulin-dependent diabetes mellitus (SPIDDM) (definite), or with type 1 diabetes who currently have completely depleted endogenous insulin secretion (the onset history is unknown).

Key secondary outcomes

To describe the correlation between the staging of type 1 diabetes and the presence or absence of susceptible/resistant human leukocyte antigen (HLA) genes in participants positive for islet autoantibodies.

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

50 years-old >

Gender

Male and Female

Key inclusion criteria

1)Having a first-degree relative diagnosed with acute-onset type 1 diabetes* or SPIDDM**, or a first-degree relative with type 1 diabetes who currently have completely depleted endogenous insulin secretion (the onset history is unknown)*** (proband)
* The proband is considered to have acute-onset type 1 diabetes when he or she meets the following criteria 1 and 2. However, if islet autoantibody status are unknown, he or she is considered to have acute-onset type 1 diabetes when he or she meets the following criteria 1 and 3.
** The proband is considered to have SPIDDM when he or she meets the following criteria 2 to 4.
*** The proband is considered to have type 1 diabetes and currently have completely depleted endogenous insulin secretion (the onset history is unknown) when he or she meets the following criterion 5.
1. The condition at the time of onset meets any of the following
-Required continuous insulin treatment within 3 months after the diagnosis of diabetes
-Observed ketosis or ketoacidosis within about 3 months after the appearance of diabetes symptoms
2. He or she tested positive for any of islet autoantibodies at least once.
3. By the time of the participants enrollment, a deficiency of endogenous insulin secretion (fasting serum C-peptide under 0.6 ng/ml) was observed.
4. At the time of type 1 diabetes diagnosis, ketosis or ketoacidosis was not observed, and insulin therapy was required more than 3 months after the diagnosis of diabetes.
5. Although the onset history of type 1 diabetes is unknown, complete depletion of endogenous insulin secretion (fasting serum C-peptide below the limit of detection) was observed.
2)Being younger than 50 years old at the time of enrollment
3)Being able to give voluntary written consent (If the participant is under 18 years of age, an informed consent will be obtained from a legal representative.)

Key exclusion criteria

1)Individuals with previously diagnosed or developed type 1 or type 2 diabetes.
2)His or her proband meets any of the following criteria
1. Has been diagnosed with SPIDDM (probable), fulminant type 1 diabetes, or type 2 diabetes.
2. Has a past or current history of cancer or hepatitis.
3. The course of the type 1 diabetes at the time of diagnosis and onset is unclear.* * This criterion does not apply to probands with type 1 diabetes who currently have completely
depleted endogenous insulin secretion (the onset history is unknown).
4. Neither the presence of islet autoantibodies at the time of diagnosis nor residual endogenous insulin secretion capacity is known.

Target sample size

2000

Research contact person

Name of lead principal investigator

1st name Daisuke

Middle name

Last name Chujo

Organization

International University of Health and Welfare Ichikawa Hospital

Division name

Diabetese, Metabolism and Endocrinology

Zip code

272-0827

Address

6 1 14, Kohnodai, Ichikawa, Chiba 272-0827, Japan

TEL

047-375-1111

Email

chujo-daisuke-rv@iuhw.ac.jp

Public contact

Name of contact person

1st name Takashi

Middle name

Last name Takahashi

Organization

IQVIA Services Japan

Division name

Real World Evidence Services

Zip code

108-0074

Address

Keikyu Daiichi Building, 4 10 18 Takanawa, Minato ku, Tokyo

TEL

0120-363-017

Homepage URL

http://mrl-type1diabetes-lp.s3-website-ap-northeast-1.amazonaws.com/clinical-trial/index.html

Email

SHR-SD-PREP_T1D_Studyoffice@iqvia.com

Sponsor or person

Institute

Sanofi K. K.

Institute

Department

Personal name

Funding Source

Organization

Sanofi K. K.

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

Nihonbashi Sakura Clinic Ethics review board

Address

5F, Inamura Building,1-9-2, Nihonbashikayabacho, Chuo-ku,, Tokyo

Tel

03-6661-9061

Email

c-irb_ug@neues.co.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国際医療福祉大学市川病院（千葉県）
富山大学附属病院(富山県）
埼玉医科大学病院（埼玉県）
大阪医科薬科大学病院（大阪府）
あべのメディカルクリニック（大阪府）
医療法人社団純英会　赤井町クリニック（千葉県）
医療法人あやめ内科（山口県）
公益財団法人慈愛会いづろ今村病院（鹿児島県）
岩手医科大学附属病院（岩手県）
浦上小児内分泌・糖尿病クリニック（東京都）
H.E.C サイエンスクリニック（神奈川県）
医療法人　岡田内科クリニック（福岡県）
岡山済生会総合病院（岡山県）
金沢大学附属病院（石川県）
京都大学大学院医学系研究科（京都府）
近畿大学医学部（大阪府）
群馬大学医学部附属病院（群馬県）
慶應義塾大学病院（東京都）
公益財団法人大原記念倉敷中央医療機構　倉敷中央病院（岡山県）
越谷レイクタウン内科（埼玉県）
レイクタウン内科大宮駅前院（埼玉県）
札幌医科大学附属病院（北海道）
昭和大学病院（東京都）
昭和大学藤が丘病院（神奈川県）
社会医療法人天神会新古賀病院（福岡県）
医療法人社団陣内会陣内病院（熊本県）
せいの内科クリニック（福島県）
医療法人純正会ソレイユ千種クリニック（愛知県）
千葉大学医学部附属病院（千葉県）
D Medical Clinic Osaka（大阪府）
東京慈恵会医科大学附属病院（東京都）
医療法人健清会那珂記念クリニック（茨城県）
長崎大学病院（長崎県）
新潟大学医歯学総合病院（新潟県）
八王子糖尿病内科クリニック（東京都）
糖尿病・甲状腺・内科はっとりクリニック知立（愛知県）
弘前大学医学部附属病院（青森県）
北海道大学病院（北海道）
医療法人南昌江内科クリニック（福岡県）
医療法人社団杜の木会もりの木クリニック（熊本県）
山梨大学大学院（山梨県）
医療法人社団ユスタヴィア（東京都）
神戸大学医学部附属病院（兵庫県）
大阪公立大学大学院医学研究科（大阪府）
市立札幌病院（北海道）
東京女子医科大学病院（東京都）
県立広島病院（広島県）
さいたま赤十字病院（埼玉県）
順天堂大学医学部附属静岡病院（静岡県）
医療法人緑風会みどりクリニック（長崎県）
順天堂大学医学部附属順天堂医院（東京都）
国立国際医療研究センター病院（東京都）
医療法人社団ゆるぎない愛の会中島内科クリニック（神奈川県）
日本大学病院（東京都）
独立行政法人労働者健康安全機構横浜労災病院（神奈川県）
独立行政法人国立病院機構四国こどもとおとなの医療センター（香川県）
中野島糖尿病クリニック（神奈川県）
いるまこどもひまわりクリニック（埼玉県）
医療法人社団桜一会かんの内科（東京都）
黒瀬クリニック（広島県）
しぶや医院（埼玉県）
ほたるのセントラル内科（千葉県）
JA長野厚生連　佐久医療センター（長野県）
じょうおにこにこクリニック（福岡県）
しみずクリニックふさ（埼玉県）
平和台病院（宮崎県）
おおはま糖尿病・腎クリニック（埼玉県）
静岡県立こども病院（静岡県）
いな内科・糖尿病クリニック（山口県）

Other administrative information

Date of disclosure of the study information

2024 Year 08 Month 23 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

2624

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

No longer recruiting

Date of protocol fixation

2024 Year 07 Month 16 Day

Date of IRB

2024 Year 09 Month 17 Day

Anticipated trial start date

2024 Year 09 Month 18 Day

Last follow-up date

2026 Year 09 Month 30 Day

Date of closure to data entry

2026 Year 10 Month 31 Day

Date trial data considered complete

2026 Year 11 Month 15 Day

Date analysis concluded

2027 Year 03 Month 31 Day

Other

Other related information

Multi-center study

Management information

Registered date

2024 Year 08 Month 23 Day

Last modified on

2025 Year 09 Month 03 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062861