Development of Obesity and Bariatric Surgery

NCT03296605 | Enrolling By Invitation

• 1 other identifier: AF/SC-08/02.0
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• Immunity cells

  Ratio of immunity cells in circulating and adipose or liver tissue

  up to 5 years

Secondary Outcomes (9)

• Body weight and height

  up to 5 years

• Insulin

  up to 5 years

• Cytokine

  up to 5 years

• Cognitive Assessment (MMSE)

  up to five years

• Cognitive Assessment (MoCA)

  up to 5 years

Study Arms (2)

Obesity

Patients with obesity already received bariatric surgery

Healthy control

Volunteers with normal body weight and already received abdominal surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obesity patients and controls

You may qualify if:

• Body mass index ≥18 kg/m2
• already received bariatric surgery or abdonimal surgery

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

Location

Related Publications (4)

• Tang W, Ge K, Shen L, Wang H, Feng W, Sun X, Chu X, Zhu D, Yin H, Bi Y. Th1 bias of liver mucosal-associated invariant T cells promotes hepatic gluconeogenesis in type 2 diabetes mellitus. Diabetes Metab Res Rev. 2023 May;39(4):e3620. doi: 10.1002/dmrr.3620. Epub 2023 Feb 17.

  PMID: 36738300 DERIVED

• Liu F, He J, Liu B, Zhang P, Wang H, Sun X, Chu X, Guan W, Feng W, Bi Y, Zhu D. Association of Omental Adipocyte Hypertrophy and Fibrosis with Human Obesity and Type 2 Diabetes. Obesity (Silver Spring). 2021 Jun;29(6):976-984. doi: 10.1002/oby.23155. Epub 2021 May 4.

  PMID: 33943025 DERIVED

• Yuan X, Chen J, Cheng Q, Zhao Y, Zhang P, Shao X, Bi Y, Shi X, Ding Y, Sun X, Xue B. Hepatic expression of Yin Yang 1 (YY1) is associated with the non-alcoholic fatty liver disease (NAFLD) progression in patients undergoing bariatric surgery. BMC Gastroenterol. 2018 Oct 3;18(1):147. doi: 10.1186/s12876-018-0871-2.

  PMID: 30285651 DERIVED

• Zhang P, Ge Z, Wang H, Feng W, Sun X, Chu X, Jiang C, Wang Y, Zhu D, Bi Y. Prolactin improves hepatic steatosis via CD36 pathway. J Hepatol. 2018 Jun;68(6):1247-1255. doi: 10.1016/j.jhep.2018.01.035. Epub 2018 Feb 13.

  PMID: 29452209 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Adipose tissue, Liver tissue

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 28, 2017
• Study Start: March 1, 2017
• Primary Completion: March 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

CN (1)