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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033439
Receipt No. 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 2019/05/22

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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
Middle name
Last name Toshinari Takamura
Organization Kanazawa University Graduate School of Medical Sciences
Division name Department of Endocrinology and Metabolism
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2234
Email ttakamura@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumie Takeshita
Organization Kanazawa University Graduate School of Medical Sciences
Division name Department of Endocrinology and Metabolism
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2234
Homepage URL
Email takeshita@m-kanazawa.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Sciences
Department of Endocrinology and Metabolism
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 04 Month 06 Day
Last follow-up date
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
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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