Inflammation and Obesity-associated Disease

Obesity Clinical Trial

— Adipos2  

Official title:

Inflammation and Obesity-associated Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02322073
• Other study ID #: 682-14
• Status: Recruiting
• Start date: December 1, 2014
• Est. completion date: December 2025

Study information

• Verified date: October 2021
• Source: Göteborg University
• Contact: Ville R Wallenius, MD, PhD.
• Phone: +46313421000
• Email: ville.wallenius[@]gastro.gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Fibrosis
• Inflammation
• Kidney Disease
• Kidney Diseases
• Liver Disease
• Liver Diseases
• Metabolic Syndrome
• Obesity
• Syndrome

Intervention

Procedure:
• Laparoscopic surgery
Roux-en-Y gastric bypass or other benign laparoscopic surgery

Locations

Country	Name	City	State
Sweden	Sahglrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory status	inflammatory status vs cardiometabolic disease and tissue fibrosis	One year