Study on the Mechanism of lcn2 in Obesity

Obesity; Endocrine Clinical Trial

Official title:

Study on the Mechanism of lcn2 in Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573998
• Other study ID #: LCN2
• Status: Recruiting
• Start date: July 1, 2016
• Est. completion date: May 30, 2024

Study information

• Verified date: September 2020
• Source: Shanghai 10th People's Hospital
• Contact: Le Bu, Dr.
• Phone: (86)021-66301004
• Email: geyingjun[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity; Endocrine

Intervention

Procedure:
• LSG
bariatric surgery

Locations

Country	Name	City	State
China	Department of Endocrinology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shen Qu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LCN2 level	Lipocalin 2 level	2019-2024
Primary	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	FBG	patients with fasting blood glucose 6.1mmol/l or more	2019-2024
Secondary	PBG	patients with 2 hour blood glucose 7.8mmol/l or more	2019-2024