NCT02674230

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

14.9 years

First QC Date

January 26, 2016

Last Update Submit

February 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body weight

    10 years

Secondary Outcomes (3)

  • Major Cardiovascular Adverse Events

    3, 6, 12, and 18 months. 2, 5, and 10 years

  • Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) questionnaire

    3, 6, 12, and 18 months. 2, 5, and 10 years

  • Personal chronotype (biological clock) as assessed by Munich Chronotype Questionnaire

    3, 6, 12, and 18 months. 2, 5, and 10 years

Study Arms (3)

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.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age ≥ 20 years old
  • Body mass index ≥ 24 kg/m2
  • For normal subjects, Body mass index \< 24 kg/m2

You may not qualify if:

  • No inform consent
  • Use of steroid medications
  • Severe systemic diseases or organ failure with estimated life expectancy of 6 months or less

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A. Serum. B. White blood cells. C. Adipose tissue. (If receiving liposuction, plastic surgery, bariatric surgery, dermatological procedure, intra-abdominal operation, and cardiovascular surgery)

MeSH Terms

Conditions

ObesityChronobiology DisordersCardiovascular Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System Diseases

Study Officials

  • Chao-Yung Wang, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Yung Wang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 4, 2016

Study Start

July 1, 2011

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations