Beijing Friendship Hospital Metabolic Surgery Database

Beijing Friendship Hospital Metabolic Surgery Clinical 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: Recruiting
• Conditions: Metabolic Surgery

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Zhongtao Zhang, M.D.; Phone Number: +86-13801060364; Email: zhangzht@ccmu.edu.cn
• Study Contact Backup: Name: Mengyi Li, M.D.; Phone Number: +86-15810993198; Email: muzi_1990@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Friendship Hospital
    • Contact: Zhongtao Zhang, M.D.; Phone Number: +86-13801060364; Email: zhangzht@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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 (LSG or 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Zhongtao Zhang, M.D., Beijing Friendship Hospital

Publications and helpful links

General Publications

• Lv H, Li M, Liu Y, Zhao L, Sun J, Cao D, Zeng N, Liu J, Liu Y, Bian S, Zhang P, Yang Z, Zhang Z, Wang Z. The Clinical Value and Appropriateness Criteria of Upper Abdominal Magnetic Resonance Examinations in Patients Before and After Bariatric Surgery: a Study of 837 Images. Obes Surg. 2020 Oct;30(10):3784-3791. doi: 10.1007/s11695-020-04688-w.
• Zhang P, Liu Y, Lv H, Li MY, Yu FX, Wang Z, Ding HY, Wang LX, Zhao KX, Zhang ZY, Zhao PF, Li J, Yang ZH, Zhang ZT, Wang ZC. Integration of Neural Reward Processing and Appetite-Related Signaling in Obese Females: Evidence From Resting-State fMRI. J Magn Reson Imaging. 2019 Aug;50(2):541-551. doi: 10.1002/jmri.26576. Epub 2019 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: metabolic surgery; metabolic disease
• Other Study ID Numbers: BFH-MSD

Drug and device information, study documents

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