Beijing Friendship Hospital Metabolic Surgery Database

Metabolic Surgery Clinical Trial

Official title:

Beijing Friendship Hospital Metabolic Surgery Clinical Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03520699
• Other study ID #: BFH-MSD
• Status: Recruiting
• Start date: December 1, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: September 2019
• Source: Beijing Friendship Hospital
• Contact: Zhongtao Zhang, M.D.
• Phone: +86-13801060364
• Email: zhangzht[@]ccmu.edu.cn
• 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: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• be able to receive metabolic surgery (LSG or 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

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the excess weight loss effect of metabolic surgery 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 metabolic surgery	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 effect of metabolic surgery with long-time follow-ups	the decrease of HbA1c, glucose level, C-peptide and insulin levels	3 years
Secondary	the glycemic control effect of metabolic surgery with long-time follow-ups	the decrease of HbA1c, glucose level, C-peptide and insulin levels	5 years
Secondary	the glycemic control effect of metabolic surgery with long-time follow-ups	the decrease of HbA1c, glucose level, C-peptide and insulin levels	10 years
Secondary	the glycemic control effect of metabolic surgery after 1 year	the decrease of HbA1c, glucose level, C-peptide and insulin levels	1 year after surgery