UMIN-CTR Clinical Trial

Basic information
Public title	Blood endotoxin levels in impaired glucose tolerance and diabetes: prospective study
Acronym	Blood endotoxin levels and glucose metabolism
Scientific Title	Blood endotoxin levels in impaired glucose tolerance and diabetes: prospective study
Scientific Title:Acronym	Blood endotoxin levels and glucose metabolism
Region	Japan

Condition
Condition	impaired glucose tolerance (IGT) and diabetes mellitus (DM)
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of blood endotoxin levels between at admission and discharge in treatment of diabetes.
Basic objectives2	Others
Basic objectives -Others	N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of blood endotoxin levels between at admission and discharge in treatment of diabetes.
Key secondary outcomes

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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Impaired glucose tolerance and diabetes mellitus
Key exclusion criteria	1)Acute phase of infection 2)Digestive disease
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Katagiri
Organization	Tohoku University Hospital
Division name	Department of Daibetes and Metabolism
Zip code	980-8577
Address	Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi
TEL	022-717-7779
Email	ssawada@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Shojiro Middle name Last name Sawada
Organization	Tohoku University Hospital
Division name	Department of Daibetes and Metabolism
Zip code	980-8577
Address	Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi
TEL	022-717-7779
Homepage URL
Email	ssawada@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University Hospital
Address	Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi
Tel	022-717-7779
Email	ssawada@med.tohoku.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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 07 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	Completed
Date of protocol fixation	2017 Year 12 Month 06 Day
Date of IRB	2018 Year 05 Month 16 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date	2020 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	N/A

Management information
Registered date	2017 Year 12 Month 06 Day
Last modified on	2020 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034585