Comparison of Radial artery pulse wave in healthy, aged from 20 to 45, obese women according to android and gynoid fat distribution: cross sectional, exploratory clinical study
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001676
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 57
1. Premenopausal women aged from 20 to 45 lived in Gwangju or Jeonnam province.
2. Android obese type: body mass index (BMI) = 25 kg/m2 and waist to hip ratio (WHR) = 0.90
3. Gynoid obese type: BMI = 25 kg/m2 and WHR <0.85
4. Subjects who clearly understood the purpose and specificity after the full explanation of the study, and signed an informed consent with voluntary participation.
1. Patients with hypertension or subjects not diagnosed to hypertension but whose systolic blood pressure (SBP) is greater than 160 mmHg or diastolic blood pressure (DBP) is greater than 90 mmHg at the screening date.
2. Hyperlipidemia (LDL-cholesterol = 160 mg/dL or triglyceride = 500 mg/dL)
3. Diabetes or subjects whose fasting blood glucose level is greater than 126 mg/dL at the screening date.
4. Endocrine diseases such as hypothyroidism or Cushing syndrome, which can be affect to individual's weight.
5. Cardiovascular disease (heart failure, angina pectoris, myocardial infarction, and aherosclerotic heart disease) or with transplant of electric devices such as pacemaker.
6. Malignant neoplasm or lung diseases.
7. Severe renal disease (creatinine > 2.0 mg/dL)
8. Liver function disorder (alanine transaminase (ALT) or asparate aminotransferase (AST) is greater than 2.5 folds from the maximum of normal range)
9. Musculoskeletal complication or rheumatoid disease
10. Mental disorder: depression, anxiety neurosis, schizophrenia, eating disorder, alcoholism, continuous drug use.
11. Suspicious to use of drugs such as amphetamine, barbiturates, cocaine, opiods, cocaine, opioids, benzodiazepines and so on when subject has the history of drug abuse.
12. Pregnancy, nursing mother, or having the history of any contraceptives.
13. Irregular menstruation cycle generally or more than three months.
14. rapid weight variation for a month (more than 5 kg)
15. Participating any commercial diet program or antiobesity medication for the past three months.
16. Unable to perform single-stage sub-maximal treadmill walking test
17. Current smoker
18. Participate any clinical trials within three months
19. Sensitive reaction to the general pathological test
20. Refusal to an informed consent.
21. Principal investigator or research investigator deems subjects inappropriate to participate the clinical study.
22. Subjects under the absolute/relative contraindication of exercise test
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulse pressure index (PPI) measured at Gwan location on the left-wrist radial artery
- Secondary Outcome Measures
Name Time Method PPI measured at Chon and Cheok location on the left wrist radial artery;Pulse depth index (PDI) measured at Gwan, Chon, and Cheok location on the left wrist radial artery;Pulse volume index (PVI) measured at Gwan, Chon, and Cheok location on the left wrist radial artery;Change of hemodynamic measures: heart rate variablilty; area of averaged photoplethysmogram signals, respiration) at Gwan location on the radial artery before/after the single-stage sub-maximal test.;Change of radial artery pulse measures (PPI, PDI, PVI) at Gwan on the left radial artery before/after the single-stage sub-maximal treadmill walking test. ;Body composition analyzer measures: Visceral fat area (VFA), body fat mass (BFM), percent body fat (PBF), and fat free mass (FFM);Anthropometric measures (neck, chest, waist, brachia, thigh, and hip circumference);Total score of Korea version of quality of life questionnaire (KOQOL)