Adipos2: Inflammation and Obesity-associated Disease

• Sponsor: Göteborg University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02322073
• Collaborator: Vastra Gotaland Region (Other)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 132
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	Phase
Obesity; Inflammation; Kidney Disease; Liver Disease; Metabolic Syndrome; Cardiometabolic Syndrome; Fibrosis	Procedure: Laparoscopic surgery

Study Design

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

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Inflammatory status [One year]

   inflammatory status vs cardiometabolic disease and tissue fibrosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahglrenska University Hospital	Gothenburg		Sweden	S41345

Sponsors and Collaborators

• Göteborg University
• Vastra Gotaland Region

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Göteborg University
• ClinicalTrials.gov Identifier: NCT02322073
• Other Study ID Numbers: 682-14
• First Posted: Dec 22, 2014
• Last Update Posted: Oct 21, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Kidney Diseases; Obesity; Metabolic Syndrome; Syndrome; Inflammation

Study Results

No Results Posted as of Oct 21, 2021