Inflammation and Obesity-associated Disease

NCT02322073 | Unknown

• 1 other identifier: 682-14
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Inflammation; Kidney Disease; Liver Disease; Metabolic Syndrome; Cardiometabolic Syndrome; Fibrosis

Outcome Measures

Primary Outcomes (1)

• Inflammatory status

  inflammatory status vs cardiometabolic disease and tissue fibrosis

  One year

Study Arms (2)

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

Obese

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

Interventions

Laparoscopic surgery PROCEDURE

Roux-en-Y gastric bypass or other benign laparoscopic surgery

Lean healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Sahglrenska University Hospital

Gothenburg, S41345, Sweden

RECRUITING

Related Publications (1)

• Borgeson E, Wallenius V, Syed GH, Darshi M, Lantero Rodriguez J, Biorserud C, Ragnmark Ek M, Bjorklund P, Quiding-Jarbrink M, Fandriks L, Godson C, Sharma K. AICAR ameliorates high-fat diet-associated pathophysiology in mouse and ex vivo models, independent of adiponectin. Diabetologia. 2017 Apr;60(4):729-739. doi: 10.1007/s00125-017-4211-9. Epub 2017 Feb 10.

  PMID: 28188334 DERIVED

MeSH Terms

Conditions

Obesity; Inflammation; Kidney Diseases; Liver Diseases; Metabolic Syndrome; Fibrosis

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Ville R Wallenius, MD, PhD.

CONTACT

+46313421000; ville.wallenius@gastro.gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

SE (1)