NCT04573998

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

7.7 years

First QC Date

September 21, 2020

Last Update Submit

September 28, 2020

Conditions

Keywords

obesitylcn2

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • FBG

    2019-2024

  • PBG

    2019-2024

Interventions

LSGPROCEDURE

bariatric surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \) 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shen Qu, Dr.

    Shanghai 10th People's Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2020

First Posted

October 5, 2020

Study Start

July 1, 2016

Primary Completion

March 1, 2024

Study Completion

May 30, 2024

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations