UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017887 |
|---|---|
| Receipt number | R000020720 |
| Scientific Title | Cross-sectional study for the relationship between nighttime sleep duration, midday naps and type2 diabetes |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2023/12/19 01:31:43 |
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Basic information
Public title
Cross-sectional study for the relationship between nighttime sleep duration, midday naps and type2 diabetes
Acronym
Cross-sectional study for the relationship between sleep and type2 diabetes
Scientific Title
Cross-sectional study for the relationship between nighttime sleep duration, midday naps and type2 diabetes
Scientific Title:Acronym
Cross-sectional study for the relationship between sleep and type2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes, IGT
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between nighttime sleep duration, midday naps and the glycemic control or other clinical indices in Japanese patients with type 2 diabetes or impaired glucose tolerance.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
FPG, serum HbA1c, C-peptide, lipids, albuminuria and blood pressure in each subgroup with different nighttime sleep duration/quality with or without midday naps
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese patients who are diagnosed as type 2 diabetes or IGT
Key exclusion criteria
advanced renal dysfunction (serum creatinine>2.0 mg/dL), chronic hepatic and cardiopulmonary disease
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Makino |
Organization
Osaka Gyomeikan Hospital
Division name
Internal Medicine
Zip code
554-0012
Address
5-4-8 Nishikujo, Konohana-ku, Osaka 554-0012, Japan
TEL
06-6462-0261
makinos@ares.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Toshihisa |
| Middle name | |
| Last name | Saka |
Organization
Osaka Gyomeikan Hospital
Division name
Department of Urology
Zip code
554-0012
Address
5-4-8 Nishikujo, Konohana-ku, Osaka 554-0012, Japan
TEL
06-6462-0261
Homepage URL
uro-saka@gyoumeikan.or.jp
Sponsor or person
Institute
Osaka Gyomeikan Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Osaka Gyomeikan Hospital
Address
5-4-8 Nishikujo, Konohana-ku, Osaka 554-0012, Japan
Tel
0664620261
makinos@ares.eonet.ne.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
| 2015 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000020720&flwp_key=3008TrwUQkO
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1016/j.sleep.2017.11.1124
Number of participants that the trial has enrolled
398
Results
Poor sleep quality and quantity could aggravate glycemic control (HbA1c>7%) in type 2 diabetes. Midday naps could mitigate the deleterious effects of short nighttime sleep (<5 h) on glycemic control.
Results date posted
| 2023 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese patients diagnosed with type 2 diabetes (n=355) or impaired glucose tolerance (n=43) were enrolled. They completed a self-administered questionnaire on sleep duration/quality.
Participant flow
A total of 398 patients were divided into five groups according to their self-reported nighttime sleep durations;<5h, 5-6h, 6-7h, 7-8h, and >8h.Each group was further divided into two subgroups each according to the presence or absence of midday naps.
Adverse events
nine
Outcome measures
glycemic control (Poor glycemic control was defined as HbA1c>7%)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Poor sleep quality and quantity could aggravate glycemic control in type 2 diabetes. Midday naps could mitigate the deleterious effects of short nighttime sleep (<5h) on glycemic control. This data was published in Sleep Medicine (44: 4-11, 2018). We are currently examining whether sleep apnea could modify the association between short nighttime sleep duration and the poor glycemic control.
Management information
Registered date
| 2015 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020720
