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Inflammation and Obesity-associated Disease (Adipos2)

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ClinicalTrials.gov Identifier: NCT02322073
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : October 21, 2021
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
Visceral obesity and adipose inflammation is considered a driving force of obesity-related systemic disease, e.g. cardiometabolic disease, liver cirrhosis and chronic kidney disease (CKD). Inflammatory resolution is actively regulated by specialized pro-resolving mediators (SPMs), including the endogenous eicosanoid LXA4. Impairment of SPMs may underlie development of obesity-related pathology.We hypothesize that obese patients who develop obesity-related disease do so because they suffer from impaired endogenous production of pro-resolving lipids. This will result in aggravated adipose inflammation and fibrosis, which contribute to the systemic pathologies. We thus wish to investigate adipose inflammation and the pro-resolving lipid profile of obese subjects with and without obesity associated metabolic disease. We also aim to investigate whether LXA4, LXB4 and other anti-inflammatory agents (such as AICAR) can alter the phenotype of human adipose macrophages in ex vivo tissue culture. We also investigate basic pathways in inflammatory regulation and obesity related cardiometabolic disease.

Condition or disease Intervention/treatment
Obesity Inflammation Kidney Disease Liver Disease Metabolic Syndrome Cardiometabolic Syndrome Fibrosis Procedure: Laparoscopic surgery

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammation and Obesity-associated Disease
Actual Study Start Date : December 1, 2014
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Group/Cohort Intervention/treatment
Lean healthy controls
Healthy controls with BMI 18.5-24.9 Laparoscopic surgery eg cholecystectomy, fundoplication or Heller myotomy and fundoplication or laparoscopic hernia repair.
Procedure: Laparoscopic surgery
Roux-en-Y gastric bypass or other benign laparoscopic surgery

Obese
Obese BMI 35-55 Laparoscopic Roux-en-Y gastric bypass or Sleeve gastrectomy Phenotype according to cardiometabolic status



Primary Outcome Measures :
  1. Inflammatory status [ Time Frame: One year ]
    inflammatory status vs cardiometabolic disease and tissue fibrosis



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Obese individuals planned for Roux-en-Y gastric bypass or Sleeve gastrectomy surgery and lean healthy controls planned for elective benign laparoscopic surgery.
Criteria

Inclusion Criteria:

  • Obese BMI 35-55 kg/m2
  • Lean BMI 18.5-24.9

Exclusion Criteria:

  • Medical treatment with NSAIDs, corticosteroid treatment, immune-suppressants.
  • Other: smoking, alcohol abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322073


Contacts
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Contact: Ville R Wallenius, MD, PhD. +46313421000 ville.wallenius@gastro.gu.se

Locations
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Sweden
Sahglrenska University Hospital Recruiting
Gothenburg, Sweden, S41345
Contact: Ville R Wallenius, MD, PhD.    +46313421000    ville.wallenius@gastro.gu.se   
Principal Investigator: Ville R Wallenius, MD, PhD.         
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02322073    
Other Study ID Numbers: 682-14
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Kidney Diseases
Obesity
Metabolic Syndrome
Syndrome
Inflammation
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Urologic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases