UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044123 |
|---|---|
| Receipt number | R000050385 |
| Scientific Title | An observational prospective cohort study of the effects of perioperative adipose tissue acute inflammation on surgical diabetes |
| Date of disclosure of the study information | 2021/05/07 |
| Last modified on | 2021/05/06 23:02:00 |
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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
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
teradayo@belle.shiga-med.ac.jp
Sponsor or person
Institute
National Hospital Organization, Higashi-Ohmi General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050385
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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