UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020955
Receipt number R000024180
Scientific Title Study on exocrine pancreatic autoantibodies and pancreatic functions in diabetic patients
Date of disclosure of the study information 2016/02/10
Last modified on 2020/08/19 10:51:01

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Basic information

Public title

Study on exocrine pancreatic autoantibodies and pancreatic functions in diabetic patients

Acronym

Exocrine pancreatic antibodies in diabetes (EXP-DIABETES STUDY)

Scientific Title

Study on exocrine pancreatic autoantibodies and pancreatic functions in diabetic patients

Scientific Title:Acronym

Exocrine pancreatic antibodies in diabetes (EXP-DIABETES STUDY)

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Study on the presence of autoantibodies against exocrine pancreas and pancreatic digestive functions in various type of diabetic patients

Basic objectives2

Others

Basic objectives -Others

Biological changes

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Presence of autoantibodies against exocrine pancreas and pancreatic digestive dysfunctions in diabetic patients

Key secondary outcomes

Blood glucose value, HbA1c, pancreatic enzyme (amylase, lipase, trypsin) levels, pancreatic tissue changes


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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Diabetic patient (including possible case)

Key exclusion criteria

heavy alcohol user, pancreatitis, diabetic nephropathy (stage 3 or more), diabetic ketoacidosis, pregnancy, hepatic cirrhosis, malignant tumor

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Tetsuro
Middle name
Last name Kobayashi

Organization

Okinaka Memorial Institute for Medical Research

Division name

Division of Immunology and Molecular Medicine

Zip code

105-8470

Address

2-2-2 Toranomon, Minato-ku, Tokyo, Japan

TEL

03-3588-1111

Email

tetsurou@yamanashi.ac.jp


Public contact

Name of contact person

1st name Tetsuro
Middle name
Last name Kobayashi

Organization

Okinaka Memorial Institute for Medical Research

Division name

Division of Immunology and Molecular Medicine

Zip code

105-8470

Address

2-2-2 Toranomon, Minato-ku, Tokyo, Japan

TEL

03-3588-1111

Homepage URL


Email

tetsurou@yamanashi.ac.jp


Sponsor or person

Institute

Okinaka Memorial Institute for Medical Research

Institute

Department

Personal name



Funding Source

Organization

Okinaka Memorial Institute for Medical Research

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Department of Medicine, Showa University School of Medicine.
Department of Endocrinology and Metabolism, Toranomon Hospital.
Department of Medicine Saiseikai Central Hospital.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB in Toranomon Hospital

Address

2-2-2 Toranomon, Minato-ku, Tokyo, Japan

Tel

03-3588-1111

Email

chiken-jim@toranomon.gr.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

2016 Year 02 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

Preinitiation

Date of protocol fixation

2015 Year 11 Month 25 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 10 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Case-control study. Subjects: All diabetic patients, who have visited our institutions between 2002(April)-2022(March) and met the inclusion criteria. Study subjects will be recruited by voluntary base and informed consent will be obtained. Measurement: Pancreatic exocrine autoantibodies, pancreatic digestive function markers, serum amylase, lipase, trypsin, elastase1, creatinine, albumin, CRP.


Management information

Registered date

2016 Year 02 Month 09 Day

Last modified on

2020 Year 08 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024180


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name