UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042351 |
|---|---|
| Receipt number | R000048347 |
| Scientific Title | A backward-looking observational study of the association between sleep, diet, quality of life, treatment burden and long-term glycemic control and complications in patients with diabetes |
| Date of disclosure of the study information | 2020/11/04 |
| Last modified on | 2020/11/04 22:57:52 |
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Basic information
Public title
A backward-looking observational study of the association between sleep, diet, quality of life, treatment burden and long-term glycemic control and complications in patients with diabetes
Acronym
A backward-looking observational study of the association between sleep, diet, quality of life, treatment burden and long-term glycemic control and complications in patients with diabetes
Scientific Title
A backward-looking observational study of the association between sleep, diet, quality of life, treatment burden and long-term glycemic control and complications in patients with diabetes
Scientific Title:Acronym
A backward-looking observational study of the association between sleep, diet, quality of life, treatment burden and long-term glycemic control and complications in patients with diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) Association of sleep duration and sleep quality with long-term blood glucose, lipids, blood pressure control, and liver and kidney function.
2) The relationship between dietary content of diabetic patients and long-term blood glucose, lipid, blood pressure control, and hepatic and renal function.
3) Association of patient quality of life and treatment burden with long-term glycemic control, lipid and blood pressure control, and hepatic and renal function.
1) to 3) will be comprehensively reviewed.
Basic objectives2
Others
Basic objectives -Others
(1) Association of sleep duration and sleep quality with long-term blood glucose, lipids, blood pressure control, and liver and kidney function.
2) The relationship between dietary content of diabetic patients and long-term blood glucose, lipid, blood pressure control, and hepatic and renal function.
3) Association of patient quality of life and treatment burden with long-term glycemic control, lipid and blood pressure control, and hepatic and renal function.
1) to 3) will be comprehensively reviewed.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Relationship between baseline sleep habits and blood sugar, lipids, blood pressure control, and liver and kidney function
2) Relationship between dietary habits at baseline and blood sugar, lipids, blood pressure control, and liver and kidney function
3) Relationship between patient quality of life, treatment burden and blood glucose, lipid, blood pressure control, and liver and kidney function at baseline
Key secondary outcomes
1) HbA1c, fasting blood glucose, postprandial blood glucose, IRI
2) Lipids
3) BMI
4) Age.
5) Gender.
6) Various anti-diabetic drugs and insulin
7) eGFR, Stage of nephropathy
8) Blood pressure (systolic and diastolic)
9) QOL score (PAID questionnaire, BDHQ questionnaire, DTRQOL questionnaire, PSQI questionnaire)
In addition, the QOLscore of the "Study on the relationship between sleep quality and dietary intake and various metabolic indices" is based on the data collected in a previous study. The current study will not include a new questionnaire.
Base
Study type
Others,meta-analysis etc
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 enrolled in the "The Sleep and Food Registry in Kanagawa (SOREKA), Japan," forms part of a multicenter prospective study (UMIN Clinical Trial Registry 000014318) who are eligible for follow-up will be included in the study.
Key exclusion criteria
Patients for whom patient information could not be collected at the institution at 1, 2, 3 or 4 years
Target sample size
3513
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Metabolism
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Kanagawa
TEL
045-261-5656
yamakat@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Sugiyama |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Metabolism
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Kanagawa
TEL
045-261-5656
Homepage URL
konmai25@gmail.com
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
The study will be conducted using basic research funds and scholarship donations from companies and others to the Department of Endocrinology and Diabetes, Yokohama City University Medical Center.
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
Yokohama City University Hospital, a public university Center for Advanced Medical Sciences, 5th Floor, P504 Clinical Trial Management Office
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
Tel
0457872714
chiken@yokohama-cu.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
| 2020 | Year | 11 | Month | 04 | 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
3513
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study using information from existing medical records, selecting cases based on the "The Sleep and Food Registry in Kanagawa (SOREKA)," registry information.
Management information
Registered date
| 2020 | Year | 11 | Month | 04 | Day |
Last modified on
| 2020 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048347
