Development of Obesity and Bariatric Surgery

October 11, 2018 updated by: Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Impacts of Bariatric Surgery on Obesity in China

This study focus on the cause of obesity and impacts of bariatric surgery on it.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obesity patients and controls

Description

Inclusion Criteria:

  1. Body mass index ≥18 kg/m2
  2. already received bariatric surgery or abdonimal surgery

Exclusion Criteria:

  1. acute stroke or acute myocardial infarction in 6 months
  2. autoimmune disease
  3. long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs
  4. pregnancy
  5. consists with other endocrine diseases
  6. acute infection in2 weeks
  7. cancer
  8. use of antibiotics in 3 months
  9. chronic digestive inflammations 9

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Obesity
Patients with obesity already received bariatric surgery
Healthy control
Volunteers with normal body weight and already received abdominal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunity cells
Time Frame: up to 5 years
Ratio of immunity cells in circulating and adipose or liver tissue
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight and height
Time Frame: up to 5 years
Body weight and height will be combined to report BMI in kg/m^2
up to 5 years
Insulin
Time Frame: up to 5 years
Insulin (mIU/L) concentartions in serum and adipose tissue
up to 5 years
Cytokine
Time Frame: up to 5 years
Cytokines concentrations in circulating and adipose or liver tissue
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

March 30, 2025

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF/SC-08/02.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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