UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025654 |
|---|---|
| Receipt number | 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 | 2021/07/18 15:01:12 |
* 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
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
Relationship between sleep duration and quality and the following factors
1) HbA1c, fasting blood glucose, postprandial blood glucose, IRI
2) Lipids
3) BMI
4) Age
5) Gender
6) Various anti-diabetic drugs, insulin
7) eGFR, stage of nephropathy
8) Blood pressure (systolic, diastolic)
9) QOL score (PAID questionnaire, etc.)
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
200
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 Diabetes
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
naibunpi@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Ichikawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
t196009c@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
Yokohama City University Certified Institutional Review Board
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
0453707627
rinri@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
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
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
| 2021 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029091
