OCEAN Registry: Obesity and Clock for Elegant Aging Registry

Obesity Clinical Trial

— OCEAN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02674230
• Other study ID #: 100-0250A3
• Status: Recruiting
• Start date: July 2011
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: Chao-Yung Wang, MD
• Phone: 886-3-3281200
• Email: cwang[@]ocean.ag
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cardiovascular Disease
• Cardiovascular Diseases
• Chronobiology Disorders
• Circadian Dysregulation
• Obesity

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		10 years
Secondary	Major Cardiovascular Adverse Events		3, 6, 12, and 18 months. 2, 5, and 10 years
Secondary	Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) questionnaire		3, 6, 12, and 18 months. 2, 5, and 10 years
Secondary	Personal chronotype (biological clock) as assessed by Munich Chronotype Questionnaire		3, 6, 12, and 18 months. 2, 5, and 10 years