Autophagy and Inflammasome in Obesity: Effect of Weight Loss and Potential Therapeutic Implications

NCT ID: NCT05071391

Last Updated: 2021-10-08

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

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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The main aim of this project is to determine the implication of autophagy and inflammasome in the pathogenesis of obesity and related comorbidities, and to explore in depth the mechanisms associated with the activation of immune cells leading early stages of the atherosclerotic process and metabolic disease. The hypothesis of the present study is that weight loss mediated by Roux-en-Y gastric bypass (RYGB) improves the protein expression of markers of autophagy and inflammation within immune cells. Moreover, the investigators will explore the association of these mechanisms with the mitochondrial function and dynamics, Endoplasmic Reticulum (ER) stress an intracellular nutritional status of leukocytes (measured by fluorescence microscopy and western blot). Further, the potential relationship between changes in the mentioned intracellular pathways and systemic pathological mechanisms including oxidative stress, inflammation and glucose and lipid metabolism will be explored. Hence, serum carbonylated proteins, myeloperoxidase (MPO) levels, antioxidant enzymatic activities including SOD (Superoxide dismutase) and catalase, circulating cytokines, and glucose and lipid metabolism parameters will be evaluated in a cohort of obese subjects before and 12 months after RYGB intervention.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese

Obese patients undergoing Roux-en-Y gastric bypass

Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Gastric bypass, also called Roux-en-Y gastric bypass, is a type of weight-loss surgery that involves creating a small pouch from the stomach and connecting the newly created pouch directly to the small intestine. After gastric bypass, swallowed food will go into this small pouch of stomach and then directly into the small intestine, thereby bypassing most of your stomach and the first section of your small intestine.

Gastric bypass is one of the most commonly performed types of bariatric surgery. Gastric bypass is done when diet and exercise haven't worked or when you have serious health problems because of your weight.

Interventions

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Roux-en-Y gastric bypass

Gastric bypass, also called Roux-en-Y gastric bypass, is a type of weight-loss surgery that involves creating a small pouch from the stomach and connecting the newly created pouch directly to the small intestine. After gastric bypass, swallowed food will go into this small pouch of stomach and then directly into the small intestine, thereby bypassing most of your stomach and the first section of your small intestine.

Gastric bypass is one of the most commonly performed types of bariatric surgery. Gastric bypass is done when diet and exercise haven't worked or when you have serious health problems because of your weight.

Intervention Type PROCEDURE

Other Intervention Names

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RYGB

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) ≥ 30 kg/m\^2
* duration of obesity over 5 years

Exclusion Criteria

* history of drug abuse
* pregnancy or lactation
* neoplastic disease
* severe renal/hepatic disease
* history of cardiovascular disease
* chronic inflammatory disease
* secondary cause for obesity (hypothyroidism, Cushing's syndrome)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milagros Rocha Barajas

OTHER

Sponsor Role lead

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Hospital Universitario Doctor Peset

OTHER

Sponsor Role collaborator

Responsible Party

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Milagros Rocha Barajas

Senior Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Milagros Rocha Barajas, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Locations

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Hospital Universitario Doctor Peset

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PI16/00301

Identifier Type: -

Identifier Source: org_study_id

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