UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014318 |
|---|---|
| Receipt number | R000016670 |
| Scientific Title | Association of sleep duration and food intake with metabolic markers in patients with diabetes,endocrine disease |
| Date of disclosure of the study information | 2014/06/20 |
| Last modified on | 2022/06/27 13:06:52 |
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Basic information
Public title
Association of sleep duration and food intake with metabolic markers in patients with diabetes,endocrine disease
Acronym
Quality and quantity of sleep and food intake in patients with diabetes,endocrine disease
Scientific Title
Association of sleep duration and food intake with metabolic markers in patients with diabetes,endocrine disease
Scientific Title:Acronym
Quality and quantity of sleep and food intake in patients with diabetes,endocrine disease
Region
| Japan |
Condition
Condition
Diabetes mellitus, endocrine disease
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 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)Diabetes, endocrine disease 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
4000
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 | Minori |
| Middle name | |
| Last name | Shinoda |
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
minoriorthomatsu@gmail.com
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 Ethics Committee
Address
3-9 Fukuura,Kanazawa-ku,Yokohama 236-0004 Japan
Tel
045-370-7629
nextjim1@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
浦舟金沢内科クリニック
横須賀市立市民病院 内分泌・糖尿病内科
藤沢市民病院 糖尿病・内分泌内科
横浜医療センター 糖尿病内分泌内科
金沢内科クリニック
谷田池田医院
医療生協かながわ生活協同組合戸塚診療所
高井内科クリニック
みながわ内科クリニック
早稲田医院
いしかわ内科クリニック
東林間かねしろ内科クリニック
鶴間かねしろ内科クリニック
ふれあい内科クリニック
ふれあい横浜ホスピタル
中島内科クリニック
小磯診療所
高橋内科クリニック
小磯診療所
港南台内科クリニック
いどがやケンズクリニック
横須賀共済病院 内分泌糖尿病内科
国際医療福祉大学熱海病院 内分泌代謝内科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
None
Publication of results
Partially published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
4241
Results
PLoS ONE 13(1):e0191771.The mean global PSQI score was 5.94+- 3.33, and 47.6% of the patients had a score of 6 or higher. Regarding the components of the PSQI, the score was highest for sleep duration, followed by subjective sleep quality and then sleep latency in decreasing order. When the patients were assigned to HbA1c quartiles, the top quartile had a significantly higher global PSQI score than the other quartiles.
Results date posted
| 2022 | Year | 06 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 4241 patients with diabetes aged 20 years or older were registered between July 2014 and March 2016.
Participant flow
The exclusion criteria were 1) patients with drug-induced diabetes or steroid treatment; 2) patients with history of diabetic ketoacidosis or diabetic coma within 6 months prior to study entry; 3) patients receiving renal replacement therapy; 4) patients before or after surgery, 5) female patients who were pregnant or breast-feeding; 6) patients with other serious diseases in addition to diabetes, such as advanced malignancy, severe infection, severe trauma, and decompensated liver cirrhosis; and 7) other patients who were judged to be inappropriate for the study by the physicians. Among the 4241 patients enrolled in this registry, 3511 patients had T2DM. After excluding 137 patients because of failure to complete the questionnaire and 80 patients because of no glycated albumin data, 3294 patients with T2DM were analyzed.
Adverse events
none
Outcome measures
The mean global PSQI score was 5.94+-3.33,and 47.6% of the patients had a score of 6 or higher.Regarding the components of the PSQI, the score was highest for sleep duration,followed by subjective sleep quality and then sleep latency in decreasing order.When the patients were assigned to HbA1c quartiles (<=6.5%,6.6-7.0%,7.1-7.8%,and>=7.9%),the top quartile had a significantly higher global PSQI score than the other quartiles.The top HbA1c quartile had a sleep duration of only 6.23+-1.42 hours,which was significantly shorter than in the other quartiles. Also,sleep latency was 25.3+-31.8 minutes in the top quartile,which was significantly longer (by approximately 20 minutes) than in the other quartiles.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 03 | 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
| 2014 | Year | 06 | Month | 19 | Day |
Last modified on
| 2022 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016670
