NCT03520699

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Dec 2017Dec 2028

Study Start

First participant enrolled

December 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

10.1 years

First QC Date

April 17, 2018

Last Update Submit

September 9, 2019

Conditions

Metabolic Surgery

Keywords

metabolic surgerymetabolic disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • the adverse events rate of metabolic surgery

    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 effect of metabolic surgery with long-time follow-ups

    3 years

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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 (LSG or LRYGB)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32483745DERIVED

  • 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.

    PMID: 30653786DERIVED

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Zhongtao Zhang, M.D.

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongtao Zhang, M.D.

CONTACT

+86-13801060364zhangzht@ccmu.edu.cn

Mengyi Li, M.D.

CONTACT

+86-15810993198muzi_1990@126.com

Study Design

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

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 11, 2018

Study Start

December 1, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

CN(1)