UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043300 |
|---|---|
| Receipt number | R000049363 |
| Scientific Title | Effect of obesity surgery on gastric motility, QOL and glucose metabolism |
| Date of disclosure of the study information | 2021/02/11 |
| Last modified on | 2021/02/10 19:12:37 |
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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
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
hfukui@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Division of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049363
