UMIN-CTR Clinical Trial

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
Email	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
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	Innovative Clinical Research Center, Kanazawa University.
Address	13-1 takaramachi kanazawa
Tel	076-265-2110
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038128