UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042351
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email konmai25@gmail.com

Sponsor
Institute Department of Endocrinology and Metabolism, Yokohama City University Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048347

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.