Clinical Trial: OCEAN Registry: Obesity and Clock for Elegant Aging Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient 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

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 Summary:

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.


Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome: Body weight [ Time Frame: 10 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Major Cardiovascular Adverse Events [ Time Frame: 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 ]
  • Personal chronotype (biological clock) as assessed by Munich Chronotype Questionnaire [ Time Frame: 3, 6, 12, and 18 months. 2, 5, and 10 years ]


Original Secondary Outcome: Same as current

Information By: Chang Gung Memorial Hospital

Dates:
Date Received: January 26, 2016
Date Started: July 2011
Date Completion: June 2026
Last Updated: February 2, 2016
Last Verified: February 2016