- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674230
OCEAN Registry: Obesity and Clock for Elegant Aging Registry (OCEAN)
OCEAN Registry: Obesity and Clock for Elegant Aging Registry 肥胖控制及生理時鐘之研究計畫
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Chao-Yung Wang, MD, Chang Gung Memorial Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100-0250A3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain