Study on the Mechanism of lcn2 in Obesity

Obesity is now becoming a worldwide serious problem. Obesity is associated with a spectrum of severe diseases, including diabetes, cardiovascular diseases, and cancers. Lipocalin 2 (LCN2), also known as neutrophil gelatinase associated lipocalin (NGAL), is a member of the lipocalin family. Due to its upregulated expression in infection, LCN2 is originally considered to be a key regulator of immune response. Subsequent investigations revealed that LCN2 is expressed in many tissues and is related to a variety of diseases, including obesity. LCN2 was reported to be increased in obesity individuals. Thus, the investigators decide to investigate the relationship between LCN2 and obesity.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Endocrine
• Intervention / Treatment: Procedure: LSG

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Le Bu, Dr.; Phone Number: (86)021-66301004; Email: geyingjun@hotmail.com
• Study Contact Backup: Name: Shen Qu, Dr.; Phone Number: (86)021-66301004; Email: qushencn@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200070
      • Recruiting
      • Department of Endocrinology, Shanghai Tenth People's Hospital
      • Contact: Shen Qu, M.D. Ph.D; Phone Number: 86-21-66302531; Email: qushencn@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

500 Patients from Shanghai Tenth People's Hospital were enrolled in this study.

Description

Inclusion Criteria:

1) age ranged from 16-65 years old, 2) BMI over 37.5kg/m2, or BMI over 32.5kg/m2 with diabetes which meets the recommended cut off bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.

Exclusion Criteria:

1) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc.,2)pregnancy or location, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesion, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LCN2 level	Lipocalin 2 level	2019-2024
meet the criteria of metabolism in the 2017 Chinese guideline	Abdominal obesity (or central obesity), male abdominal circumference ≥90cm, female abdominal circumference ≥85cm;	2019-2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FBG	patients with fasting blood glucose 6.1mmol/l or more	2019-2024
PBG	patients with 2 hour blood glucose 7.8mmol/l or more	2019-2024

Collaborators and Investigators

• Sponsor: Shen Qu
• Investigators: Study Chair: Shen Qu, Dr., Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: obesity; lcn2
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: LCN2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No