Obesity-related Inflammation in Patients Prior to and After Bariatric Surgery

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

Study Overview

• Status: Completed
• Conditions: Obesity; Morbid Obesity

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Two study populations: Healthy control defined as systemically healthy and not taking medication or supplements with a BMI less than 27; Bariatric participants who fit the inclusion and exclusion criteria, but may also present with co-morbidities associated with obesity.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with a BMI over 40; Participants were aged between 27-65 years, BMI >40 , Co-Morbidities associated with obesity including sleep apnoea, hypertension, depression, hypercholesterolaemia and type 2 diabetes, Undergoing Gastric Band surgery
Lean, healthy individuals; Participants were aged between 27-65 years, BMI<28 , Systemically healthy, taking no prescribed medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical Markers associated with Inflamation	(IL-8, IL-1, ROS, Production of NETS)	OCT 2016

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: University Hospital Birmingham NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ACTUAL): August 28, 2016
• Study Completion (ACTUAL): October 28, 2016

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (ACTUAL): September 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Morbid obesity; gastric bypass; Matched Healthy Controls
• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Inflammation; Obesity, Morbid
• Other Study ID Numbers: ERN_13-0355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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