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NCT Number: NCT03520699

Beijing Friendship Hospital Metabolic Surgery 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.

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Key information

Conditions

Metabolic Surgery Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. the excess weight loss effect of metabolic surgery after 1year

    Time frame: 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 outcomes

  1. the adverse events rate of metabolic surgery

    Time frame: 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）

  2. the excess weight loss effect of metabolic surgery with long-time follow-ups

    Time frame: 3 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)

  3. the excess weight loss effect of metabolic surgery with long-time follow-ups

    Time frame: 5 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)

  4. the excess weight loss effect of metabolic surgery with long-time follow-ups

    Time frame: 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)

  5. the glycemic control effect of metabolic surgery with long-time follow-ups

    Time frame: 3 years

    the decrease of HbA1c, glucose level, C-peptide and insulin levels

  6. the glycemic control effect of metabolic surgery with long-time follow-ups

    Time frame: 5 years

    the decrease of HbA1c, glucose level, C-peptide and insulin levels

  7. the glycemic control effect of metabolic surgery with long-time follow-ups

    Time frame: 10 years

    the decrease of HbA1c, glucose level, C-peptide and insulin levels

  8. the glycemic control effect of metabolic surgery after 1 year

    Time frame: 1 year after surgery

    the decrease of HbA1c, glucose level, C-peptide and insulin levels

Study contacts

Contact information is provided by the study sponsor or research team.

Mengyi Li, M.D.

CONTACT

[email protected]

+86-15810993198

Zhongtao Zhang, M.D.

CONTACT

[email protected]

+86-13801060364

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

Beijing Friendship Hospital Metabolic Surgery Clinical Database

Important dates

Study start
2017
Primary completion
2027
Study completion
2028
First posted
May 11, 2018
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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