UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028221 |
|---|---|
| Receipt number | R000032301 |
| Scientific Title | Analysis of circulating hormone levels after sleeve gastrectomy in severe obese patients |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2024/01/17 10:53:19 |
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Basic information
Public title
Analysis of circulating hormone levels after sleeve gastrectomy in severe obese patients
Acronym
Hormone analysis after sleeve gastrectomy
Scientific Title
Analysis of circulating hormone levels after sleeve gastrectomy in severe obese patients
Scientific Title:Acronym
Hormone analysis after sleeve gastrectomy
Region
| Japan |
Condition
Condition
Severe obese patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sleeve gastrectomy is effective therapy for treatment of severe obese patients. The surgery not only reduce their body weight, but improve diabetes mellitus, hypertension and dyslipidemia. However, it's unknown the mechanisms that the surgery improve these metabolic complications in severe obesity.
In this study we'll analyze metabolic hormones before and after sleeve gastrectomy on severe obesity, and clarify the molecular mechanisms that the surgery improve metabolic complications.
Basic objectives2
Others
Basic objectives -Others
We will collect blood sample before and after sleeve gastrectomy (3, 6, 12, 24 months after operation) and measure metabolic hormone levels (FGF21, Ghrelin, Glucagon, GLP-1) using ELISA kit.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analyze circulating hormone levels (FGF21, Ghrelin, Glucagon, GLP-1) before and after sleeve gastrectomy on severe obesity.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study intends for severe obese patients (BMI>35) complicated with diabetes, hypertension or dislipidemia.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | MITSURU |
| Middle name | |
| Last name | NISHIYAMA |
Organization
Kochi Medical School, Kochi University
Division name
Department of Endocrinolgy, Metabolism & Nephrology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku city, Kochi 783-8505, Japan
TEL
088-880-2343
nisiyamm@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | MITSURU |
| Middle name | |
| Last name | NISHIYAMA |
Organization
Kochi Medical School, Kochi University
Division name
Department of Endocrinology, Metabolism & Nephrology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku city, Kochi 783-8505, Japan
TEL
088-880-2343
Homepage URL
nisiyamm@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Next-generation medical creation center
Address
Kohasu, Okoh-cho, Nankoku city, Kochi 783-8505
Tel
088-880-2180
is21@kochi-u.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 | 08 | Month | 01 | Day |
Related information
URL releasing protocol
The period has been extended due to the fact that there are still no participants in this study.
Publication of results
Unpublished
Result
URL related to results and publications
The period has been extended due to the fact that there are still no participants in this study.
Number of participants that the trial has enrolled
0
Results
The period has been extended due to the fact that there are still no participants in this study.
Results date posted
| 2024 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The period has been extended due to the fact that there are still no participants in this study.
Participant flow
The period has been extended due to the fact that there are still no participants in this study.
Adverse events
None
Outcome measures
The period has been extended due to the fact that there are still no participants in this study.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
If metabolic hormone levels (FGF21, Ghrelin, Glucagon, GLP-1) are changed after sleeve gastrectomy on severe obese patients, these hormones may be associated with improving metabolic complications after surgery.
Management information
Registered date
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032301
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