OCEAN Registry: Obesity and Clock for Elegant Aging Registry (OCEAN)

February 27, 2024 updated by: Chao-Yung Wang, Chang Gung Memorial Hospital

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

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chao-Yung Wang, MD
  • Phone Number: 8750 886-3-3281200
  • Email: cwang@ocean.ag

Study Locations

      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:
          • Chao-Yung Wang, MD
          • Phone Number: 8750 886-3-3281200
          • Email: cwang@ocean.ag
        • Principal Investigator:
          • Ming-Shien Wen, MD
        • Principal Investigator:
          • Chao-Yung Wang, MD
        • Principal Investigator:
          • Ta-Sen Yeh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from the general population including healthcare facility and non-health care settings. Healthcare facility includes university based hospital and primary care clinics. Non-health care settings include schools, subjects families, and employment agencies.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Extreme obesity
BMI ≥35kg/m2
Obesity
BMI 24-34.9kg/m2
Normal subjects
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
Time Frame
Body weight
Time Frame: 10 years
10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chao-Yung Wang, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimated)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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