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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025654
Receipt No. R000029091
Scientific Title Association of sleep duration and food intake with metabolic markers in patients with type 1 diabetes
Date of disclosure of the study information 2017/01/12
Last modified on 2017/01/12

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Basic information
Public title Association of sleep duration and food intake with metabolic markers in patients with type 1 diabetes
Acronym Quality and quantity of sleep and food intake in patients with type 1 diabetes
Scientific Title Association of sleep duration and food intake with metabolic markers in patients with type 1 diabetes
Scientific Title:Acronym Quality and quantity of sleep and food intake in patients with type 1 diabetes
Region
Japan

Condition
Condition type 1 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the relationship between quality/quantity of sleep or food intake and glycemic control, metabolic markers, blood pressure or quality of life in patients with type 1 diabetes.
Basic objectives2 Others
Basic objectives -Others Observational study based on the quastionnaire
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) sleep duration
2) quality of sleep
3) nutrition components (carbohydrate, fat, protain)
Key secondary outcomes To analyze factors which influence their sleep duration and nutrition components

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
85 years-old >
Gender Male and Female
Key inclusion criteria 1)type 1 Diabetes patients
2) Before test registration
- age more than 20, less than 80
3) Patients with written IC
Key exclusion criteria 1) severe ketosis, diabetic coma within 6 months
2) severe infection, before operation or severe trauma
3) Pregnancy
4) Patients judged by the investigator to be ineligible for some other reason
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Yamakawa
Organization Yokohama City University Medical Center
Division name Department of Endocrinology and Diabetes
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email naibunpi@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohide Masutani
Organization Yokohama City University Medical Center
Division name Department of Endocrinology and Diabetes
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email masutani.tomohide@gmail.com

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 12 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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study based on the quastionnaire
Pittsburgh Sleep Quality Index (PSQI)
Diabetes therapy Related QOL(DTR-QOL)problem areas in diabetes survey(PAID)
brief-type self -administered diet history questionnaire(BDHQ)

Management information
Registered date
2017 Year 01 Month 12 Day
Last modified on
2017 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029091

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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