OCEAN Registry: Obesity and Clock for Elegant Aging Registry

Study Overview
=================
Brief Summary
-----------------
This study aims to study the relationships between obesity, circadian rhythm, and aging. The investigators set up a prospective cohort registry for morbid obesity, obesity, and normal subjects with annual follow-up. The cohort aims to investigate the pathophysiological, molecular, genetic, and cellular aspects of the relationships between obesity, circadian deregulation, and impacts on aging. Clinical data, questionnaires, biological material, and molecular signatures will be collected and investigated.

Detailed Description
-----------------
The objective of this observational study is the follow-up of 2000 adult obesity (BMI ≥ 35 and 24-35 kg/m2) and non-obese subjects with annual follow-up for 10 years. Clinical data, biochemistry, and biological samples (serum, DNA, RNA, white blood cells) will be collected and stored. Adipose tissues will be collected if participants received liposuction, plastic surgery, bariatric surgery, dermatological procedure, intra-abdominal operation, and cardiovascular surgery. Questionnaires will be obtained with special nurse including sleep quality, chronotypes, and circadian activities. During follow up period, major adverse cardiovascular events will be monitored. The investigators anticipate that the results generated from the study will provide valuable data to a better understanding of the relationships between obesity, circadian rhythm, and aging.

Official Title
-----------------
OCEAN Registry: Obesity and Clock for Elegant Aging Registry 肥胖控制及生理時鐘之研究計畫

Conditions
-----------------
Obesity, Circadian Dysregulation, Aging, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 years old Body mass index ≥ 24 kg/m2 For normal subjects, Body mass index < 24 kg/m2 Exclusion Criteria: No inform consent Use of steroid medications Severe systemic diseases or organ failure with estimated life expectancy of 6 months or less

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extreme obesity<br>BMI ≥35kg/m2 | |
| Obesity<br>BMI 24-34.9kg/m2 | |
| Normal subjects<br>BMI <24kg/m2. No systemic disease, including hypertension, diabetes, liver cirrhosis, chronic kidney disease, and psychiatric disease. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Cardiovascular Adverse Events |  | 3, 6, 12, and 18 months. 2, 5, and 10 years | 
| Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) questionnaire |  | 3, 6, 12, and 18 months. 2, 5, and 10 years | 
| Personal chronotype (biological clock) as assessed by Munich Chronotype Questionnaire |  | 3, 6, 12, and 18 months. 2, 5, and 10 years |