Inflammation and Obesity-associated Disease

Recruiting

• Conditions: Obesity; Metabolic Syndrome; Liver Disease; Fibrosis; Inflammation; Cardiometabolic Syndrome; Kidney Disease
• Interventions: Procedure: Laparoscopic surgery

• Registration Number: NCT02322073
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-01
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-22
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-21
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lean healthy controls	Laparoscopic surgery	Healthy controls with BMI 18.5-24.9 Laparoscopic surgery eg cholecystectomy, fundoplication or Heller myotomy and fundoplication or laparoscopic hernia repair.

Primary Outcome Measures

Name	Time	Method
Inflammatory status	One year	inflammatory status vs cardiometabolic disease and tissue fibrosis

Trial Locations

Locations (1)

Sahglrenska University Hospital; 🇸🇪 Gothenburg, Sweden