UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033439 |
|---|---|
| Receipt number | R000038128 |
| Scientific Title | Metabolic effects of bariatric surgery (laparoscopic sleeve gastrectomy) on endocrine abnormalities |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2021/07/20 12:44:36 |
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Basic information
Public title
Metabolic effects of bariatric surgery (laparoscopic sleeve gastrectomy) on endocrine abnormalities
Acronym
Metabolic effects of bariatric surgery on endocrine abnormalities
Scientific Title
Metabolic effects of bariatric surgery (laparoscopic sleeve gastrectomy) on endocrine abnormalities
Scientific Title:Acronym
Metabolic effects of bariatric surgery on endocrine abnormalities
Region
| Japan |
Condition
Condition
Obese patients with metabolic abonormalities
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the metabolic effects of bariatric surgery on endocrine abnormalities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement in histlogic features of NAFLD,as assessed with a composite of standardized scores for steatosis,lobular inflammation,hepatocellular ballooning,and fibrosis.Disease activity is assessed with the nonalcoholic fatty liver disease activity score,which is based on a standardized grading system for steatosis(on a scale of 0 to 3),lobular inflammation(on a scale of 0 to 3),and hepatocellular ballooning(on a scale of 0 to 2),with higher scores indicating increasing severity.
Key secondary outcomes
Change from baseline in liver enzymes
Change from baseline in body composition
Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test
Changes from baseline in organ-specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study
Change from baseline in lipid profile
Change from baseline in renal function and electrolyte balances
Change from baseline in hepatokine (Selenoprotein P, LECT2) levels
Change from baseline in organ-specific fat accumulation
Change from baseline in oxidative and non-oxidative glucose disposal
Change from baseline in respiratory quotients
Change from baseline in energy expenditure
Change from baseline in autonomic nerve function. This is performed by power-spectrum analyses of heart rate variability
Changes from baseline in minerals and bone metabolism
Changes from baseline in endothelial functions
Factors associated with the changes in autonomic nerve function, organ-specific fat accumulation, and glucagon response.
Changes from baseline in gene expression profiles in the liver and blood cells
Changes from baseline in microRNAs and exosome contents
Epigenomic changes from baseline in genes of the liver and blood cells
Changes in severity index of sleep apnea by sleeping polysomnography
Improvement of QOL evaluation by SF-36 questionnaire
Motor effect analysis by I-PAQ
Nutritional assessment by meal behavior questionnaire and FFQg
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
bariatric surgery
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)BMI 35 kg/m2 or more
2)Patients with metabolic disorders
3)at least absolved 6 months of failed conservative treatment for morbid obesity
4)Age over 20 years old
5)participants provided written informed consent
Key exclusion criteria
1)Patients who participated in other clinical studies (trials) within 3 months before the study
2)Inability to participate in the study as assessed by the investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshinari |
| Middle name | |
| Last name | Takamura |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Endocrinology and Metabolism
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2234
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Yumie |
| Middle name | |
| Last name | Takeshita |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Endocrinology and Metabolism
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2234
Homepage URL
takeshita@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Sciences
Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University.
Address
13-1 takaramachi kanazawa
Tel
076-265-2110
rinri@adm.kanazawa-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
金沢大学附属病院（石川県金沢市）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 06 | 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
Management information
Registered date
| 2018 | Year | 07 | Month | 18 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038128
