UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042726 |
|---|---|
| Receipt number | R000048773 |
| Scientific Title | Elucidation of clinical features of sarcopenic obesity and establishment of its diagnostic criteria |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2021/12/13 10:41:15 |
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Basic information
Public title
Elucidation of clinical features of sarcopenic obesity and establishment of its diagnostic criteria
Acronym
Elucidation of clinical features of sarcopenic obesity and establishment of its diagnostic criteria
Scientific Title
Elucidation of clinical features of sarcopenic obesity and establishment of its diagnostic criteria
Scientific Title:Acronym
Elucidation of clinical features of sarcopenic obesity and establishment of its diagnostic criteria
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify diagnostic criteria for sarcopenic obesity reflecting the cluster of cerebrocardiovascular disease risks in obese patients.
Basic objectives2
Others
Basic objectives -Others
To clarify clinical features of sarcopenic obesity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular disease (CVD) risk score
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who satisfy all of the following criteria.
1. BMI more than 25 kg/m2
2. Any age
3. Gender: Male and Female
4. Outpatients visiting the National Hospital Organization Kyoto Medical Center
5. Patients who have provided written informed consent
Key exclusion criteria
Patients who fall under any of the following criteria.
1. Patients with data deficiencies
2. Patients wearing pacemakers
3. Female patients who are suspected of being pregnant or pregnant
4. Patients with defects in their limbs
5. Patients judged by the doctor in charge to be ineligible for other reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Kusakabe |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
kusakabe@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Kusakabe |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
kusakabe@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
National Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
Tel
075-641-9161
yamaji.hirofumi.bg@mail.hosp.go.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
国立病院機構 京都医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Major observation items:
1. Cardiovascular disease (CVD) risk score: the comorbid number of three CVD risk factors (hypertension, diabetes, and dyslipidemia)
2. Interview: age, gender, past history, family history, current medical history, smoking history, menstrual history
3. Physical finding: height, weight, systolic and diastolic blood pressure, pulse
4. Sarcopenia-related indices: appendicular skeletal muscle mass index (SMI), handgrip strength, muscle quality
5. Obesity-related indices: body mass index (BMI), percent body fat, waist circumference
6. Blood tests: fasting plasma glucose, HbA1c, T-Cho, TG, HDL-C, LDL-C
Management information
Registered date
| 2020 | Year | 12 | Month | 11 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048773
