UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051342 |
|---|---|
| Receipt number | R000058570 |
| Scientific Title | Elucidation of induction of intra-abdominal fatty inflammation after surgery and inhibitory effect of insulin on adipose tissue-derived inflammation. |
| Date of disclosure of the study information | 2023/06/15 |
| Last modified on | 2023/06/14 15:44:52 |
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Basic information
Public title
Elucidation of induction of intra-abdominal fatty inflammation after surgery and inhibitory effect of insulin on fatty inflammation.
Acronym
Elucidation of perioperative fat inflammation inhibitory effect of insulin
Scientific Title
Elucidation of induction of intra-abdominal fatty inflammation after surgery and inhibitory effect of insulin on adipose tissue-derived inflammation.
Scientific Title:Acronym
Elucidation of inhibitory effect of insulin on perioperative adipose tissue-derived inflammation.
Region
| Japan |
Condition
Condition
Patients who are candidates for gastrointestinal surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the anti-inflammatory action of insulin suppresses the acute inflammatory response derived from adipose tissue that would be induced by laparotomy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in adipocytokine secretion ability of visceral fat (collected before abdominal closure) by insulin administration.
Key secondary outcomes
1) Changes over time in adipocytokines (visfatin, adiponectin, free fatty acids) secreted from adipose tissue
2) Changes in adipocytokine secretion ability of adipose tissue by endogenous inflammatory cytokines (TNF alpha, IL-6, TGF beta) stimulation
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) ECOG Performance Status is 0-1
2) Over 20 years of age.
3) Patients who explained the purpose and contents of this study to the patient and their families, and obtained their voluntary consent to the study.
Key exclusion criteria
1) Patients with serious organ damage (cardiac disease, respiratory disease, liver cirrhosis, renal failure, etc.)
2) Patients with a life expectancy of at least 1 month
3) Others who are judged to be unsuitable as patients by the investigator or investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Akabori |
Organization
National Hospital Organization Higashi Ohmi General Medical Center
Division name
Department of Surgery
Zip code
527-2192
Address
255 Gochi-cho, Higashioumi, Shiga
TEL
0748223030
hakabori@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Akabori |
Organization
National Hospital Organization Higashi Ohmi General Medical Center
Division name
Department of Surgery
Zip code
527-2192
Address
255 Gochi-cho, Higashioumi, Shiga
TEL
0748223030
Homepage URL
hakabori@belle.shiga-med.ac.jp
Sponsor or person
Institute
National Hospital Organization Higashi Ohmi General Medical Center
Institute
Department
Personal name
Hiroya Akabori
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
National Hospital Organization Higashi Ohmi General Medical Center
Tel
0748223030
kuki.katsuhiko.ad@mail.hosp.go.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
| 2023 | Year | 06 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(A) Blood biochemistry test: preoperative, postoperative day 1, and postoperative day 3 (-4).
(B) Measurement of adipocytokines
B-1 Blood and ascites: preoperative, immediate postoperative, postoperative day 1, 3 (-4) days
B-2 Removed adipose tissue: when the abdomen is open, when the abdomen is closed
Using visceral adipose tissue specimens (at the time of laparotomy and laparotomy), we will examine the ability of adipose tissue to secrete adipocytokines and the effect of insulin due to surgical invasion or inflammation-related factors.
(C) Cultivation of adipose tissue under inflammatory cytokine stimulation
C-1 Using adipose tissue before and after surgery, inflammatory cytokines are added and co-cultured, and adipocytokines secreted from each adipose tissue are measured. Measure and compare quantitatively. Furthermore, free fatty acid concentrations are measured.
C-2 Addition of supernatant of drain effluent collected before abdominal closure during adipose tissue culture.
It contains a wide variety of inflammatory cytokines, and is thought to resemble the inflammatory environment in the patient's abdominal cavity.
Quantitative comparison of the difference in adipocytokine production from adipose tissue between the presence and absence of liposome.
(D) Adipose tissue cultured under inflammatory cytokine and insulin stimulation
Under inflammatory cytokine co-culture conditions of adipose tissue, insulin is added to the culture medium at varying concentrations, adipocytokines secreted from adipose tissue are measured, and free fatty acid concentrations are measured, and quantitatively compare. In addition, changes in adipocytokine mRNA expression in adipose tissue are quantified by RT-PCR.
Management information
Registered date
| 2023 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058570
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