Greater China Metabolic and Bariatric Surgery Database

Metabolic Surgery Clinical Trial

Official title:

Greater China Metabolic and Bariatric Surgery Database

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03800160
• Other study ID #: GC-MBD
• Status: Enrolling by invitation
• Start date: April 1, 2018
• Est. completion date: April 1, 2029

Study information

• Verified date: May 2024
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50000
• Est. completion date: April 1, 2029
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Surgery

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (16)

Lead Sponsor

Collaborator

Beijing Friendship Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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