Clinical trial NCT02674230: OCEAN Registry: Obesity and Clock for Elegant Aging Registry
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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Circadian Dysregulation
Aging
Cardiovascular Disease
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: 10 years
Secondary outcomes:
measure: Major Cardiovascular Adverse Events
timeFrame: 3, 6, 12, and 18 months. 2, 5, and 10 years
measure: Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: 3, 6, 12, and 18 months. 2, 5, and 10 years
measure: Personal chronotype (biological clock) as assessed by Munich Chronotype Questionnaire
timeFrame: 3, 6, 12, and 18 months. 2, 5, and 10 years
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chao-Yung Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: