Beijing Friendship Hospital Metabolic Surgery Database

Recruiting

• Conditions: Metabolic Surgery

• Registration Number: NCT03520699
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-05-11
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-10
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the excess weight loss effect of metabolic surgery after 1year	1 year after surgery	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)

Secondary Outcome Measures

Name	Time	Method
the glycemic control effect of metabolic surgery after 1 year	1 year after surgery	the decrease of HbA1c, glucose level, C-peptide and insulin levels
the excess weight loss effect of metabolic surgery with long-time follow-ups	10 years	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)
the adverse events rate of metabolic surgery	30 days after surgery	show the surgical safety by 30 days follow-up according to guideline（such as: bleeding, leak, obstruction, re-operation for complication）
the glycemic control effect of metabolic surgery with long-time follow-ups	10 years	the decrease of HbA1c, glucose level, C-peptide and insulin levels

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, China