UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016958 |
|---|---|
| Receipt number | R000019683 |
| Scientific Title | The effect of structured triglyceride and physical mixed MCT/LCT on lipometabolism liver and renal function of patients with acute necroizing pancreatitis |
| Date of disclosure of the study information | 2015/03/28 |
| Last modified on | 2015/03/28 14:45:55 |
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Basic information
Public title
The effect of structured triglyceride and physical mixed MCT/LCT on lipometabolism liver and renal function of patients with acute necroizing pancreatitis
Acronym
STG and MCT/LCT on acute necroizing pancreatitis
Scientific Title
The effect of structured triglyceride and physical mixed MCT/LCT on lipometabolism liver and renal function of patients with acute necroizing pancreatitis
Scientific Title:Acronym
STG and MCT/LCT on acute necroizing pancreatitis
Region
| Asia(except Japan) |
Condition
Condition
Completed
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the influnence of STG onlipomeabolism, liver and renal fnction in patients with acute necrotizing pancreatitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
STG has a better effect on lipometabolism than physical mixed MCT/LCT in patients with acute necrotizing pancreatitis
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Diagnosis as ANP
2)Rquired parenteral nutrition support treatment more than 5 days
Key exclusion criteria
Patients with abnormal lipid metabolism
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chen JY |
Organization
Chinese PLA General Hospital
Division name
Hospital and Institute of Hepatobiliary Surgery
Zip code
Address
No.28 fuxing road , Beijing, China
TEL
+86-010-66938331
chensir338@126.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chen JY |
Organization
Chinese PLA General Hospital
Division name
Hospital and Institute of Hepatobiliary Surgery
Zip code
Address
No.28 fuxing road , Beijing, China
TEL
+86-010-66938331
Homepage URL
chensir338@126.com
Sponsor or person
Institute
The Human Ethics Committee of the Chinese PLA General Hospital
Institute
Department
Personal name
Funding Source
Organization
Chinese PLA General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Chinese PLA General Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 28 | 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
There were no harmful to liver and renal function in STG and MCT/LCT ,and STG has a better effect on lipomeabolism than MCT/LCT in patients with ANP
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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The liver fnction, renal function and lipometabolism were compared between STG group and MCT/LCT group
Management information
Registered date
| 2015 | Year | 03 | Month | 28 | Day |
Last modified on
| 2015 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019683
