OCEAN Registry: Obesity and Clock for Elegant Aging Registry

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02674230
Collaborator
(none)
2,000
1
179
11.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Jul 1, 2011
    Anticipated Primary Completion Date :
    Jun 1, 2026
    Anticipated Study Completion Date :
    Jun 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Body weight [10 years]

    Secondary Outcome Measures

    1. Major Cardiovascular Adverse Events [3, 6, 12, and 18 months. 2, 5, and 10 years]

    2. Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) questionnaire [3, 6, 12, and 18 months. 2, 5, and 10 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chang Gung Memorial Hospital Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chao-Yung Wang, Doctor, Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT02674230
    Other Study ID Numbers:
    • 100-0250A3
    First Posted:
    Feb 4, 2016
    Last Update Posted:
    Feb 1, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 1, 2019