UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049445 |
|---|---|
| Receipt number | R000056297 |
| Scientific Title | The ratio of triglyceride to high-density lipoprotein cholesterol in females may be a better indicator of metabolic syndrome and its components than in males in a Japanese population |
| Date of disclosure of the study information | 2022/11/08 |
| Last modified on | 2023/09/15 11:03:11 |
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Basic information
Public title
Gender differences in the relationship between TG/HDL-C ratio and metabolic syndrome
Acronym
Gender differences in the relationship between TG/HDL-C ratio and metabolic syndrome
Scientific Title
The ratio of triglyceride to high-density lipoprotein cholesterol in females may be a better indicator of metabolic syndrome and its components than in males in a Japanese population
Scientific Title:Acronym
Gender differences in the relationship between TG/HDL-C ratio and metabolic syndrome
Region
| Japan |
Condition
Condition
Metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to investigate, by gender, the relationship between the TG/HDL-C ratio and abdominal obesity in a Japanese population using a cross-sectional study approach.
Basic objectives2
Others
Basic objectives -Others
We aimed to clarify gender differences in the relationship between the TG/HDL-C ratio and Mets and its components.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy parameter was the relationship between the TG/HDL-C ratio and abdominal obesity by gender.
Key secondary outcomes
The secondary endpoint was the relationship between the TG/HDL-C ratio and the prevalence of Mets and its components as cardio-metabolic risk by gender.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Among 11,673 Japanese subjects who had undergone an annual health check-up between April 2019 and March 2020 at the Health Planning Center of Nihon University Hospital, 10,373 subjects (females, 4,056; males, 6,317) were recruited for this study.
Key exclusion criteria
The exclusion criteria included refusal to provide consent for participation in the study, current lipid-modified, treatment, and diagnosis of cerebral and/or cardiovascular disease, serum triglyceride levels more than 400mg/dL, and no measurement of abdominal circumference and serum lipid level.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Panning Center
Zip code
101-0062
Address
Chiyodaku-kandasurugadai 1-6,Tokyo
TEL
0332931711
tanishigem@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
101-0062
Address
Chiyodaku-kandasurugadai 1-6, Tokyo
TEL
0332931711
Homepage URL
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital, Health Planning
Center
Institute
Department
Personal name
Funding Source
Organization
Nihon University Hospital, Health Planning
Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital IRB
Address
Kandasurugadai1-6, Chiyodaku, Tokyo
Tel
0332931711
tani.shigemasa@nihon-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 08 | 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2022 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056297
