UMIN-CTR Clinical Trial

Basic information
Public title	Effect of obesity surgery on gastric motility, QOL and glucose metabolism
Acronym	Effect of obesity surgery on gastric motility, QOL and glucose metabolism
Scientific Title	Effect of obesity surgery on gastric motility, QOL and glucose metabolism
Scientific Title:Acronym	Effect of obesity surgery on gastric motility, QOL and glucose metabolism
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Gastroenterology Endocrinology and Metabolism Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the effect of obesity surgery on obesity related health disturbances (gastric dysmotility, low QOL and diabetes).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effect of obesity surgery on gastric motility
Key secondary outcomes	Effect of obesity surgery on QOL and glucose metabolism

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Obesity 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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Resistance to medical treatment for more than 6 months; BMI >= 35 kg/m2; One of the complications including diabetes, hypertension, dyslipidemia, sleep apnea syndrome. or 2) Resistance to medical treatment for more than 6 months; 34.9 >= BMI >= 32.5 kg/m2 and one of the followings: diabetes (HbA1c >= 8.4%); uncontrollable hypertension (systolic blood pressure >= 160 under the treatment with antihypertensive drug); dyslipidemia (LDL >= 140 mg/dl or non-HDL cholesterol >= 170 mg/dl under the medication for more than 6 months); sleep apnea syndrome (AHI >= 30).
Key exclusion criteria	1) Respiratory failure: AHI >= 30. 2) Renal function: Cr >= 2.0, GFR < 30. 3) Compliance: impossible to stop smoking for 4 weeks. 4) Severe liver dysfunction. 5) Mental diseases with unstable symptoms. 6) Pregnant woman, Lactating woman, woman predicting pregnancy. 7) Patients that doctors judged as unsuitable for surgery. 8) Malignancies, Organic diseases in the gastrointestinal tract, Neurodegenerative diseases, Metabolic disease except for diabetes. 9) Past surgery of esophagus or stomach. 10) H. pylori eradication within 6 months. 11) Medication: prokinetics, acid suppressant, antidepressant, psychotropic drug. Permit to enroll, if possible to stop those medications for more than 2 weeks.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Miwa
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology and Hepatology
Zip code	663-8501
Address	1-1, Mukogawa, Nishinomiya 663-8501, Japan
TEL	0798456662
Email	miwahgi@hyo-med.ac.jp

Public contact
Name of contact person	1st name Hirokazu Middle name Last name Fukui
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology and Hepatology
Zip code	663-8501
Address	1-1, Mukogawa, Nishinomiya 663-8501, Japan
TEL	0798456662
Homepage URL
Email	hfukui@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine Division of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Hyogo College of Medicine Division of Gastroenterology and Hepatology
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	Hyogo College of Medicine
Address	1-1, Mukogawa, Nishinomiya 663-8501, Japan
Tel	0798456662
Email	miwahgi@hyo-med.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	2021 Year 02 Month 11 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	2020 Year 09 Month 24 Day
Date of IRB	2020 Year 09 Month 29 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2030 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	2021 Year 02 Month 10 Day
Last modified on	2021 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049363