Clinical trial NCT03800160: Greater China Metabolic and Bariatric Surgery Database
Official title: Greater China Metabolic and Bariatric Surgery Database
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Metabolic Surgery
Keywords: metabolic surgery
metabolic disease
multicenter
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Beijing Hospital
name: Peking Union Medical College Hospital
name: Shanxi Dayi Hospital
name: The Second Hospital of Hebei Medical University
name: Tianjin Medical University General Hospital
name: Inner Mongolia People's Hospital
name: Henan Provincial People's Hospital
name: Qilu Hospital of Shandong University
name: The First Hospital of Hebei Medical University
name: The Second People's Hospital of Xinxiang Henan
name: Tangshan Gongren Hospital
name: Tianjin Nankai Hospital
name: Tianjin First Central Hospital
First posted: 2019-01-11
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with morbid obesity who are suitable and willing to accept metabolic surgical procedure and also agree with the registry

Brief summary: Metabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in Chinese patients with obesity and encouraging future research in this field.


Eligibility criteria: Inclusion Criteria:

* be able to receive metabolic surgery, including but not limit to LSG and LRYGB

Exclusion Criteria:

* can not be able to understand and willing to participate in this registry with signature

Primary outcomes:
measure: the excess weight loss effect of different metabolic surgeries after 1year
timeFrame: 1 year after surgery
Secondary outcomes:
measure: the adverse events rate of different metabolic surgeries
timeFrame: 30 days after surgery
measure: the excess weight loss effect of metabolic surgery with long-time follow-ups
timeFrame: 3 years
measure: the excess weight loss effect of metabolic surgery with long-time follow-ups
timeFrame: 5 years
measure: the excess weight loss effect of metabolic surgery with long-time follow-ups
timeFrame: 10 years
measure: the glycemic control level of metabolic surgery with long-time follow-ups
timeFrame: 1 year after surgery
measure: the glycemic control level of metabolic surgery with long-time follow-ups
timeFrame: 3 year after surgery
measure: the glycemic control level of metabolic surgery with long-time follow-ups
timeFrame: 5 year after surgery
measure: the glycemic control level of metabolic surgery with long-time follow-ups
timeFrame: 10 year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
References: