OCEAN Registry: Obesity and Clock for Elegant Aging Registry

Recruiting

• Conditions: Aging; Cardiovascular Disease; Circadian Dysregulation; Obesity

• Registration Number: NCT02674230
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight	10 years

Secondary Outcome Measures

Name	Time	Method
Personal chronotype (biological clock) as assessed by Munich Chronotype Questionnaire	3, 6, 12, and 18 months. 2, 5, and 10 years
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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan