UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047289 |
|---|---|
| Receipt number | R000053933 |
| Scientific Title | Observational study to search for factors that exacerbate the progression and prevention of lifestyle-related diseases through temporal observation of the 75g oral glucose tolerance test, gut microbiota analysis, and metabolites analysis. |
| Date of disclosure of the study information | 2022/03/26 |
| Last modified on | 2023/09/17 12:35:03 |
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Basic information
Public title
Observational study to search for factors that exacerbate the progression and prevention of lifestyle-related diseases through temporal observation of the 75g oral glucose tolerance test, gut microbiota analysis, and metabolites analysis.
Acronym
Observational study in Kumejima
Scientific Title
Observational study to search for factors that exacerbate the progression and prevention of lifestyle-related diseases through temporal observation of the 75g oral glucose tolerance test, gut microbiota analysis, and metabolites analysis.
Scientific Title:Acronym
Observational study in Kumejima
Region
| Japan |
Condition
Condition
Metabolic syndrome, obesity, pre diabetes, insulin resistance
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Metabolic analyses such as 75g oral glucose tolerance test, gut microbiota analysis, and metabolites analysis will be conducted to search for factors that contribute to the prevention of lifestyle-related diseases such as obesity and diabetes, or prevent their progression and worsening.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To search for factors that worsen the progression of lifestyle-related diseases and protective factors through the 75g oral glucose tolerance test, gut microbiota analysis, metabolites analysis, and questionnaire survey observation over time, and to evaluate their significance as early diagnostic markers and predictive markers of pathological progression.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants were residents in Kumejima island over 20 years old
Key exclusion criteria
1) severe renal dysfunction (eGFR < 30 ml/min/1.73 m2)
2) hepatic dysfunction (AST > 200 IU/L or ALT > 200 IU/L)
3) malignancy,pregnancy,
4) chronic diarrhea
5) severe illness requiring hospitalization and treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Masuzaki |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL
098-895-1146
hiroaki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Tsugumi |
| Middle name | |
| Last name | Uema |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL
098-895-1146
Homepage URL
ma2.ky8.26@gmail.com
Sponsor or person
Institute
University of the Ryukyus.
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office, Government of Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Section, Planning and Research Promotion Office, Planning Division, Uehara Campus, University of the Ryukyus
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
Tel
098-895-1542
krinken@acs.u-ryukyu.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 | 03 | Month | 26 | Day |
Related information
URL releasing protocol
URL has not yet been created
Publication of results
Unpublished
Result
URL related to results and publications
URL has not yet been created
Number of participants that the trial has enrolled
178
Results
A total of 178 subjects were recruited with 140 individuals (70 females and 70 males) able to provide all the required measurements and samples including anthropometric measurements, clinical and biochemical blood samples as well as stool samples.
Results date posted
| 2022 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
178 male and female residents of Kumejima, aged 20-75
Participant flow
A total of 178 subjects were recruited with 140 individuals (70 females and 70 males) able to provide all the required measurements and samples including anthropometric measurements, clinical and biochemical blood samples as well as stool samples.
Adverse events
None
Outcome measures
Still under analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053933
