Clinical trial NCT03520699: Beijing Friendship Hospital Metabolic Surgery Database
Official title: Beijing Friendship Hospital Metabolic Surgery Clinical Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Surgery
Keywords: metabolic surgery
metabolic disease
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: the excess weight loss effect of metabolic surgery after 1year
timeFrame: 1 year after surgery
Secondary outcomes:
measure: the adverse events rate of metabolic surgery
timeFrame: 30 days after surgery
measure: the excess weight loss effect of metabolic surgery with long-time follow-ups
timeFrame: 3 years
measure: the excess weight loss effect of metabolic surgery with long-time follow-ups
timeFrame: 5 years
measure: the excess weight loss effect of metabolic surgery with long-time follow-ups
timeFrame: 10 years
measure: the glycemic control effect of metabolic surgery with long-time follow-ups
timeFrame: 3 years
measure: the glycemic control effect of metabolic surgery with long-time follow-ups
timeFrame: 5 years
measure: the glycemic control effect of metabolic surgery with long-time follow-ups
timeFrame: 10 years
measure: the glycemic control effect of metabolic surgery after 1 year
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.