UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027753 |
|---|---|
| Receipt number | R000031801 |
| Scientific Title | Association between dietary habit and HOMA |
| Date of disclosure of the study information | 2017/06/14 |
| Last modified on | 2018/06/14 12:59:42 |
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Basic information
Public title
Association between dietary habit and HOMA
Acronym
Association between dietary habit and HOMA
Scientific Title
Association between dietary habit and HOMA
Scientific Title:Acronym
Association between dietary habit and HOMA
Region
| Japan |
Condition
Condition
Impaired glucose tolerance
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between insulin resistance assessed by homeostasis model and dietary habits.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between insulin secretion assessed by homeostasis model and dietary habits.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
HOMA-IR
Key secondary outcomes
HOMA-beta, fasting glucose, fasting insulin
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants underwent baseline check in the Nagahama cohort.
Key exclusion criteria
Participants
who were pregnant
whose fasting time were less than 10 hours
who took oral hypoglycemic agents, insulin or steroids
whoese serum creatinine levels were higher than 1.5 mg/dl
whose plasma glucose levels were inadequately low (less than 70 mg/dl or high (more than 140 mg/dl)
whose fasting serum insulin levels were too high to be considered fasting (more than 20 IU/ml)
who reported having been diagnosed with pancreatic disease
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Ikeda |
Organization
Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition Graduate School of Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3560
krikeda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Ikeda |
Organization
Kyoro University
Division name
Department of Diabetes, Endocrinology and Nutrition Graduate School of Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3560
Homepage URL
krikeda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Integration research for agriculture and interdisciplinary fields, Ministry of Agriculture, Fisheries and Forests, 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
Address
Tel
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
| 2017 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.diabres.2018.04.006
Number of participants that the trial has enrolled
Results
Dietary habits associated with lower insulin resistance were eating fish dishes every day and eating miso soup every day in females, and in males eating vegetable dishes every day.
Dietary habits associated with higher insulin resistance were eating staple foods for dinnerevery day in females,and in males eating fruits every day and eating egg dishes four or five times per week.
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
| 2015 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional analysis using a community-based cohort study, the Nagahama Prospective Cohort for Comprehensive Human Bioscience (the Nagahama Study).
Management information
Registered date
| 2017 | Year | 06 | Month | 14 | Day |
Last modified on
| 2018 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031801
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
