Greater China Metabolic and Bariatric Surgery Database

NCT03800160 | Enrolling By Invitation

• 1 other identifier: GC-MBD
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Surgery

Keywords

metabolic surgery; metabolic disease; multicenter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• the adverse events rate of different metabolic surgeries

  30 days after surgery

• the excess weight loss effect of metabolic surgery with long-time follow-ups

  3 years

• the excess weight loss effect of metabolic surgery with long-time follow-ups

  5 years

• the excess weight loss effect of metabolic surgery with long-time follow-ups

  10 years

• the glycemic control level of metabolic surgery with long-time follow-ups

  1 year after surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of general surgery, principal investigator

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: January 11, 2019
• Study Start: April 1, 2018
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CN (1)