OCEAN Registry: Obesity and Clock for Elegant Aging Registry

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

Sponsors

Lead Sponsor: Chang Gung Memorial Hospital

Source Chang Gung Memorial Hospital
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.

Overall Status Recruiting
Start Date July 2011
Completion Date June 2026
Primary Completion Date June 2026
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Body weight 10 years
Secondary Outcome
Measure 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
Enrollment 2000
Condition
Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Chao-Yung Wang, MD Principal Investigator Chang Gung Memorial Hospital
Overall Contact

Last Name: Chao-Yung Wang, MD

Phone: 886-3-3281200

Phone Ext.: 8750

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Chang Gung Memorial Hospital Chao-Yung Wang, MD 886-3-3281200 8750 [email protected] Ming-Shien Wen, MD Principal Investigator Chao-Yung Wang, MD Principal Investigator Ta-Sen Yeh, MD Principal Investigator
Location Countries

Taiwan

Verification Date

January 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chang Gung Memorial Hospital

Investigator Full Name: Chao-Yung Wang

Investigator Title: Doctor

Has Expanded Access No
Condition Browse
Arm Group

Label: Extreme obesity

Description: BMI ≥35kg/m2

Label: Obesity

Description: BMI 24-34.9kg/m2

Label: Normal subjects

Description: BMI <24kg/m2. No systemic disease, including hypertension, diabetes, liver cirrhosis, chronic kidney disease, and psychiatric disease.

Acronym OCEAN
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov