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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03283644
Other study ID # ERN_13-0355
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date October 28, 2016

Study information

Verified date February 2017
Source University of Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigates the chronic long-term health condition of obesity and its effect on neutrophil function and the inflammatory response


Description:

Inflammation is a central component of the immune response. In its acute form it aids the transition from disease to health via the activation of numerous immune cells, enabling them to reach the site of infection/injury and orchestrate themselves to combat pathogens, facilitating resolution and repair to restore the host to health. However, chronic inflammation is deleterious to the host and differs from the "classical" acute inflammatory process in that the inflammation is not necessarily so readily obvious and is not self-limiting; rather, the immune system is in a constant state of low-grade activation and when challenged by pathogenic or sterile injury the response is heightened, resulting in prolonged tissue damage and a failure of efficient resolution mechanisms.

Neutrophils are important mediators of acquired innate immune responses but may also contribute to the pathogenesis of chronic inflammatory diseases. Neutrophils are heavily involved in antimicrobial defence; their primary role is the localisation and elimination of pathogenic microorganisms. This, combined with their relatively short lifespan, has resulted in a traditional view of them as limited "kamikaze" cells. However, as detailed here, neutrophils have been shown to act with complexity and sophistication, orchestrating the immune/inflammatory response but also inadvertently contributing to tissue damage in different disease states. This study investigates the chronic long-term health condition of obesity and its effect on neutrophil function and the inflammatory response


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date October 28, 2016
Est. primary completion date August 28, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria for Bariatric participants:

- BMI >40

- Undergoing Gastric Band surgery

Exclusion Bariatric Participants Criteria:

- Undergoing alternative weight loss surgery

- BMI<40

- Smoking

- Pregnancy

Exclusion criteria for the controls

- BMI over 27

- pregnancy

- smoking

- evidence of systemic disease

- use of medications/vitamin supplements.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Birmingham Birmingham Heartlands Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Biochemical Markers associated with Inflamation (IL-8, IL-1, ROS, Production of NETS) OCT 2016
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