ObesityNCT03283644
Obesity-related Inflammation in Patients Prior to and After Bariatric Surgery
An observational study of Obesity and Morbid Obesity, run by University of Birmingham.
Trial summary
This study investigates the chronic long-term health condition of obesity and its effect on neutrophil function and the inflammatory response Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid Obesity
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to 28 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- BMI >40
- Undergoing Gastric Band surgery
Who cannot join
- Undergoing alternative weight loss surgery
- BMI<40
- Smoking
- Pregnancy
- BMI over 27
- pregnancy
Show all 9Show fewer
- smoking
- evidence of systemic disease
- use of medications/vitamin supplements.
About this study
This study investigates the chronic long-term health condition of obesity and its effect on neutrophil function and the inflammatory response
Read the 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
- Conditions
- Obesity, Morbid Obesity
- Keywords
- gastric bypass, Obesity, Morbid obesity, Matched Healthy Controls
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Markers associated with Inflamation
(IL-8, IL-1, ROS, Production of NETS)
Measured: OCT 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study startJun 2015
- Primary completion28 Aug 2016
- Study completion28 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283644
- Sponsor's protocol ID
- ERN_13-0355
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity-related Inflammation in Patients Prior to and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03283644
- Acronym / sponsor ID
- ERN_13-0355
- Conditions
- Obesity, Morbid Obesity
- Keywords
- gastric bypass, Obesity, Morbid obesity, Matched Healthy Controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University Hospital Birmingham NHS Foundation Trust
- Study start
- Jun 2015 (actual)
- Primary completion
- 28 Aug 2016 (actual)
- Study completion
- 28 Oct 2016 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the chronic long-term health condition of obesity and its effect on neutrophil function and the inflammatory response
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- BMI >40
- Undergoing Gastric Band surgery
Key exclusion criteria (9 listed)
- Undergoing alternative weight loss surgery
- BMI<40
- Smoking
- Pregnancy
- BMI over 27
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biochemical Markers associated with Inflamation
Time frame: OCT 2016
(IL-8, IL-1, ROS, Production of NETS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Morbid Obesity, run by University of Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Markers associated with Inflamation (time frame: OCT 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.