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

NCT03283644 | Completed

• 1 other identifier: ERN_13-0355
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity; Morbid Obesity

Keywords

gastric bypass; Obesity; Morbid obesity; Matched Healthy Controls

Outcome Measures

Primary Outcomes (1)

• Biochemical Markers associated with Inflamation

  (IL-8, IL-1, ROS, Production of NETS)

  OCT 2016

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• BMI \>40
• Undergoing Gastric Band surgery
• Undergoing alternative weight loss surgery
• BMI\<40
• Smoking
• Pregnancy

You may not qualify if:

• BMI over 27
• pregnancy
• smoking
• evidence of systemic disease
• use of medications/vitamin supplements.

Sponsors & Collaborators

• University of Birmingham: lead
• University Hospital Birmingham NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: September 14, 2017
• Study Start: June 1, 2015
• Primary Completion: August 28, 2016
• Study Completion: October 28, 2016
• Last Updated: December 19, 2018

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share