UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045812 |
|---|---|
| Receipt number | R000052299 |
| Scientific Title | Effects of sleeve gastrectomy on bone microarchitecture in patients with morbid obesity: a prospective cohort study using second-generation high-resolution peripheral quantitative computed tomography (HR-pQCT) |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2022/04/21 12:48:56 |
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Basic information
Public title
Effects of sleeve gastrectomy on bone microarchitecture in patients with morbid obesity: a prospective cohort study using second-generation high-resolution peripheral quantitative computed tomography (HR-pQCT)
Acronym
Effects of sleeve gastrectomy on bone microarchitecture
Scientific Title
Effects of sleeve gastrectomy on bone microarchitecture in patients with morbid obesity: a prospective cohort study using second-generation high-resolution peripheral quantitative computed tomography (HR-pQCT)
Scientific Title:Acronym
Effects of sleeve gastrectomy on bone microarchitecture
Region
| Japan |
Condition
Condition
morbid obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of weight loss after bariatric surgery or medical treatment on bone mineral density and bone microstructure in severe obesity by HR-pQCT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in bone microarchitecture at 6,12,24,and 36 months after start of treatment.
Key secondary outcomes
Changes in bone mineral density and bone metabolism markers at 6,12,24,and 36 months after start of treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
medical treatment
Interventions/Control_2
laparoscopic sleeve gastrectomy
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
Severe obese patients with BMI>32.5kg/m2 attending or hospitalized at Nagasaki University Hospital.
Key exclusion criteria
1)Patients who receive treatment now, or have received treatment within the past 12 months, by bisphosphonates, PTH, anti-RANKL antibodies, or anti-sclerostin antibodies for osteoporosis.
2)Patients with thyroid disease requiring therapeutic intervention, parathyroid disease, primary aldosteronism, Cushing's syndrome, celiac disease, inflammatory bowel disease, renal dysfunction (estimated glomerular filtration rate < 30 ml/min), or hepatic dysfunction (AST > 3 times the upper limit of the reference value).
3)Patients who receive treatment by steroid.
4)Patients who have malignancy.
5)Patients who are pregnant or who may be pregnant. Patients who are lactating.
6)Patients who have participated in other clinical studies within 6 months.
7)Other patients who are judged by the investigators to be inappropriate as research subjects.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | YOMI |
| Middle name | |
| Last name | NAKASHIMA |
Organization
Nagasaki university hospital
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197262
miu4@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | YOMI |
| Middle name | NAKASHIMA |
| Last name | NAKASHIMA |
Organization
Nagasaki university hospital
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197262
Homepage URL
miu4@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Clinical Research Center, Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
0958197726
rinshou7726@umin.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 | 11 | Month | 15 | 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
| 2021 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | 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 | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052299
