UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010920 |
|---|---|
| Receipt number | R000012671 |
| Scientific Title | Observational study of efficacy of glucose level in saliva as a marker of blood sugar in perioperative or diabetic patients |
| Date of disclosure of the study information | 2013/06/10 |
| Last modified on | 2013/12/28 21:36:14 |
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Basic information
Public title
Observational study of efficacy of glucose level in saliva as a marker of blood sugar in perioperative or diabetic patients
Acronym
Observational study of efficacy of glucose level in saliva as a marker of blood sugar
Scientific Title
Observational study of efficacy of glucose level in saliva as a marker of blood sugar in perioperative or diabetic patients
Scientific Title:Acronym
Observational study of efficacy of glucose level in saliva as a marker of blood sugar
Region
| Japan |
Condition
Condition
1.diabetes mellitus
2.intracranial vessel disease
Classification by specialty
| Endocrinology and Metabolism | Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of glucose level in saliva as an alternative method of blood sugar measurement
Basic objectives2
Others
Basic objectives -Others
Laboratory equivalency
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between glucose levels of blood and saliva
Key secondary outcomes
Analysis of factors relating to correlation between glucose levels of blood and saliva
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A. Diabetic in-patients in Fukuoka University hospital, received examinations for blood sugar
B. Preoperative in-patients with intracranial vessel disease such as un-rupture cerebral aneurysm in Fukuoka University hospital, received monitoring of arterial blood pressure during operation
Key exclusion criteria
1. No written informed consent
2. Patient ineligible to the study based on investigator's decision
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Haraga |
Organization
Fukuoka University
Division name
Department of Anesthesiology
Zip code
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
haraga_i@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Haraga |
Organization
Fukuoka University
Division name
Department of Anesthesiology
Zip code
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
Homepage URL
http://www.hop.fukuoka-u.ac.jp/rinshou/doctor/shounin.html
haraga_i@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Department of Anesthesiology
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
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 10 | 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
| 2013 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case control
Glucose levels in saliva and blood
Significant correlation
Management information
Registered date
| 2013 | Year | 06 | Month | 10 | Day |
Last modified on
| 2013 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012671
