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Inflammation and Obesity-associated Disease

NCT ID: NCT02322073

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Obesity Inflammation Kidney Disease Liver Disease Metabolic Syndrome Cardiometabolic Syndrome Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Laparoscopic surgery

Intervention Type PROCEDURE

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

No interventions assigned to this group

Interventions

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Laparoscopic surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sahglrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Ville R Wallenius, MD, PhD.

Role: CONTACT

[email protected]
+46313421000

Facility Contacts

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Ville R Wallenius, MD, PhD.

Role: primary

[email protected]
+46313421000

References

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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.

Reference Type DERIVED
PMID: 28188334 (View on PubMed)

Other Identifiers

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682-14

Identifier Type: -

Identifier Source: org_study_id