Collecting of tongue image data and oral characteristics data in diabetic patients and healthy control: multicenter trial
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0004358
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 190
* Diabetic patient selection criteria
1) Subjects who take diabetic medication or fasting blood glucose level = 126mg/dl.
2) Subjects who have voluntarily agreed in writing to participate in the clinical study.
3) Subjects who can communicate with clinical researchers.
* Inclusion criteria for healthy subject
1) Subjects who not take diabetes medication and fasting blood glucose level <100mg/dl.
2) Subjects who have voluntarily agreed in writing to participate in the clinical study.
3) Subjects who can communicate with clinical researchers.
1) Subjects who had serious organic diseases.
2) Subjects who can not limit oral activity for 4 hours.
3) Subjects who had eaten an as following foods within 4 hours: coffee, coloring ice cream which can be dyed the color of tongue coating.
4) Subjects who had drunk a alcohol within 4 hours.
5) Subjects who had experienced a smoking within 1 hour.
6) Pregnant or breastfeeding women.
7) Subjects who were viewed as inappropriate for the clinical study by the research head or staff.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method calculated tongue features (tongue body/coating color, tongue coating thickness, teeth mark level) from tongue image
- Secondary Outcome Measures
Name Time Method amount of saliva;bio impedance assessment;Qi, Blood, Yin and Yang deficiency questionnaire;Yin deficiency questionnaire;dry mouth symptom questionnaire;Korea Sasang constitutional diagnostic questionnaire;carotid ultrasonography