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

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ClinicalTrials.gov Identifier: NCT03283644
Recruitment Status : Active, not recruiting
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
Birmingham Heartlands Hospital
Information provided by (Responsible Party):
University of Birmingham

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

Condition or disease
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
Actual Enrollment : 43 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Obesity-related Inflammation in Patients Prior to and After Bariatric Surgery
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Biochemical Markers associated with Inflamation [ Time Frame: OCT 2016 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT03283644     History of Changes
Other Study ID Numbers: ERN_13-0355
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Birmingham:
gastric bypass
Obesity
Morbid obesity
Matched Healthy Controls

Additional relevant MeSH terms:
Obesity
Inflammation
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes