None listed
Conditions
Interventions
None listed
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Common 1) Adult men and women above the age of 40 2) Those with hemoglobin levels within the normal range (men: 3-17 g/dL,women: 12-16g/dL) - Diabetic Group (should satisfy one or more of the below criteria) 1) Those with mild to moderate type 1 or type 2 diabetes on diet or medication control based on the WHO criteria 2) Those with fasting glucose level between 126mg/dL and 250mg/dL upon screening 3) Those with HbA1c of 6.5% or more - Healthy Control Group (should satisfy one or more of the below criteria) 1) Those without prior history of type 1 or type 2 diabetes 2) Those with fasting glucose level of 100mg/dL or less upon screening 3) Those with HbA1c of 6.0% or less
Exclusion criteria
Exclusion criteria: - Common 1) Those with or without previously diagnosed hypertension with sitting Systolic blood pressure(SBP) = 160 mmHg or Diastolic blood pressure(DBP) = 90mmHg as measured on the day of screening after resting for 3 minutes or more 2) Those with severe renal dysfunction (Creatinine(Cr) > 2.0mg/dL) 3) Those with thyroid diseases, such as hypothyroidism 4) Those with previously diagnosed liver dysfunction (alanine aminotransferse(ALT) or aspartate aminotransferase(AST) greater than 2.5x of the upper normal limit) 5) Those with previous history or established diagnosis of cardiovascular disease 6) Those with symptomatic anemia 7) Smokers 8) Those with previous history of drug or alcohol abuse 9) Those with cardiac pacemakers or other electronic implants 10) Those with adverse reactions (including skin reactions) to electrode attachment 11) Those with hypersensitivity reaction after basic examination 12) Pregnant or breastfeeding women, or women of child-bearing age who are currently on oral contraceptives 13) Those who participated in another clinical research in the past 3 months 14) Those who did not sign the subject agreement 15) Those who are involved in the administration of this research or those who are deemed unfit for this research by the administrators - Diabetic Group (should satisfy one or more of the below criteria) 1) Those with HbA1c of 8.5% or above 2) Those who are on pre-meal anti-hyperglycemic agents - Healthy Control Group 1) Those who have been previously diagnosed with pre-diabetes, including impaired glucose tolerance or impaired fasting glucose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve(AUC) value calculated from the eceiver operating characteristic (ROC) curve of diabetes classification model using a variable measurement from equipment(Sudoscan, Inbody S10, Near-infrared spectroscopy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Sudoscan measures;Inbody S10 measures;Near-infrared spectroscopy measures;Total score of Qi Blood Yin Yang Deficiency Questionnaire;Total score of Cold and Heat Pattern Questionnaire;laboratory test measures | — |
Countries
Korea, Republic of
Contacts
Public Contactmin jung Kim
Dunsan Korean Medicine Hospital of Daejeon University
Outcome results
None listed