Greater China Metabolic and Bariatric Surgery Database

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Metabolic Surgery

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the excess weight loss effect of different metabolic surgeries after 1year	Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the adverse events rate of different metabolic surgeries	show the surgical safety by 30 days follow-up according to guideline（such as: bleeding, leak, obstruction, re-operation for complication）	30 days after surgery
the excess weight loss effect of metabolic surgery with long-time follow-ups	Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)	3 years
the excess weight loss effect of metabolic surgery with long-time follow-ups	Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)	5 years
the excess weight loss effect of metabolic surgery with long-time follow-ups	Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)	10 years
the glycemic control level of metabolic surgery with long-time follow-ups	the change of HbA1c, glucose level, C-peptide and insulin levels	1 year after surgery
the glycemic control level of metabolic surgery with long-time follow-ups	the change of HbA1c, glucose level, C-peptide and insulin levels	3 year after surgery
the glycemic control level of metabolic surgery with long-time follow-ups	the change of HbA1c, glucose level, C-peptide and insulin levels	5 year after surgery
the glycemic control level of metabolic surgery with long-time follow-ups	the change of HbA1c, glucose level, C-peptide and insulin levels	10 year after surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Peking Union Medical College Hospital; Beijing Tiantan Hospital; The Second Hospital of Hebei Medical University; Qilu Hospital of Shandong University; Beijing Hospital; Beijing Shijitan Hospital, Capital Medical University; Henan Provincial People's Hospital; Tianjin Medical University General Hospital; Tianjin First Central Hospital; The First Hospital of Hebei Medical University; Tianjin Nankai Hospital; Shanxi Dayi Hospital; Inner Mongolia People's Hospital; Tangshan Gongren Hospital; The Second People's Hospital of Xinxiang Henan

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ANTICIPATED): April 1, 2028
• Study Completion (ANTICIPATED): April 1, 2029

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (ACTUAL): January 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: multicenter; metabolic surgery; metabolic disease
• Other Study ID Numbers: GC-MBD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No