UMIN-CTR Clinical Trial

Basic information
Public title	An observational prospective cohort study of the effects of perioperative adipose tissue acute inflammation on surgical diabetes
Acronym	Association of perioperative adipose tissue acute inflammation and surgical diabetes
Scientific Title	An observational prospective cohort study of the effects of perioperative adipose tissue acute inflammation on surgical diabetes
Scientific Title:Acronym	Association of perioperative adipose tissue acute inflammation and surgical diabetes
Region	Japan

Condition
Condition	Gastric and colon tumors
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will examine the relationship between perioperative surgical diabetes and acute adipose tissue inflammation in patients undergoing gastrointestinal surgery as a prospective observational cohort study.
Basic objectives2	Others
Basic objectives -Others	We will examine the relationship between perioperative surgical diabetes and acute adipose tissue inflammation in patients undergoing gastrointestinal surgery as a prospective observational cohort study.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of change in perioperative insulin resistance
Key secondary outcomes	1) Perioperative blood glucose fluctuation and insulin secretory capacity 2) Time course of adipose tissue-derived factors and stress hormones 3) Visceral fat area 4) Postoperative complication rate (4 weeks after surgery) 5) Safety (clinical test values, vital signs)

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) ECOG Performance Status is 0-1 2) Age is 20 years or older. 3) Patients who fully explained the purpose and content of this study to patients and their families, and obtained the patient's free will consent for the study.
Key exclusion criteria	1) Cases with serious organ disorders (heart disease, respiratory disease, liver cirrhosis, renal failure, etc.) 2) Cases in which the prognosis for life is not expected for more than 1 month 3) In addition, those who are judged to be inappropriate as patients by the investigator or the doctor in charge
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Terada
Organization	National Hospital Organization, Higashi-Ohmi General Medical Center
Division name	Department of Surgery
Zip code	527-8505
Address	Gochi-cho 255, Higashiohmi, Shiga
TEL	0748-22-3030
Email	teradayo@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Yoshitaka Middle name Last name Terada
Organization	National Hospital Organization, Higashi-Ohmi General Medical Center
Division name	Department of Surgery
Zip code	527-8505
Address	Gochi-cho 255, Higashiohmi, Shiga
TEL	0748-22-3030
Homepage URL
Email	teradayo@belle.shiga-med.ac.jp

Sponsor
Institute	National Hospital Organization, Higashi-Ohmi General Medical Center
Institute
Department

Funding Source
Organization	Nikkiso Co., Ltd.
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	National Hospital Organization, Higashi-Ohmi General Medical Center
Address	Gochi-cho 255, Higashiohmi, Shiga
Tel	0748-22-3030
Email	teradayo@belle.shiga-med.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	東近江総合医療センター（滋賀県）

Other administrative information
Date of disclosure of the study information	2021 Year 05 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 29 Day
Date of IRB	2021 Year 04 Month 12 Day
Anticipated trial start date	2021 Year 05 Month 10 Day
Last follow-up date	2023 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In addition to perioperative blood biochemical tests and insulin secretory capacity, measurement of inflammation-related factors / adipose-related factors in drainage and adipose tissue, and examination of symptoms and incidence of complications occurring within 4 weeks after surgery .

Management information
Registered date	2021 Year 05 Month 06 Day
Last modified on	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050385