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

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 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

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

Value
https://center6.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