Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071391
Other study ID # PI16/00301
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2019

Study information

Verified date September 2021
Source Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
Spain Hospital Universitario Doctor Peset Valencia

Sponsors (3)

Lead Sponsor Collaborator
Milagros Rocha Barajas Hospital Universitario Doctor Peset, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the protein expression of autophagy markers in leukocytes 12 months after the RYGB intervention Relative expression of intracellular proteins related autophagy/mitophagy mechanisms (Beclin 1, ATG5, LC3II/I, NRB1, PINK1, MIEAP) assessed by western blot and normalized to the loading control protein. 12 months
Primary Changes in the relative protein expression of inflammatory mediators in leukocytes 12 months after the RYGB intervention Relative expression of intracellular proteins related to inflammatory pathways (MCP1, NF-kB) assessed by western blot and normalized to the loading control protein. 12 months
Secondary Changes in the protein expression of markers of mitochondrial dynamics and function in leukocytes 12 months after the RYGB intervention. Relative expression of proteins related to mitochondrial dynamics and function (OPA1, FIS1, MFN1, DRP1, MFN2, OXPHOS Complex, MTTFA, PGC1a, NRF1, BNIP3) assessed by western blot and normalized to the loading control protein. Changes in mitochondrial membrane potential of leukocytes after the intervention assessed by fluorescence dye TMRM. 12 months
Secondary Changes in the protein expression of markers of nutrient sensing and ER stress in leukocytes 12 months after the RYGB intervention. Relative expression of proteins related to nutritional status, metabolism and Endoplasmic Reticulum (ER) stress (AMPK, SIRT1, ATF6, CHOP) assessed by western blot and normalized to the loading control protein. 12 months
Secondary Changes in superoxide production 12 months after the RYGB intervention. Evaluation of superoxide production in leukocytes by means of fluorescence dye (Relative Fluorescence Units) as contributor to pro-oxidant processes. 12 months
Secondary Changes in serum MPO levels 12 months after the RYGB intervention. Evaluation of serum levels of the prooxidant MPO by immunoassay ELISA (ng/mL) as contributor to pro-oxidant and pro-inflammatory processes. 12 months
Secondary Changes in protein carbonylation in serum 12 months after the RYGB intervention. Evaluation of carbonyl groups in serum proteins by means of immunoassay ELISA (nmol/mg protein) as a marker of systemic oxidative damage. 12 months
Secondary Changes in serum SOD enzymatic activity 12 months after the RYGB intervention. Evaluation of SOD enzymatic activity in serum (nmol/min/mL) as part of the systemic antioxidant defense system. 12 months
Secondary Changes in serum catalase enzymatic activity 12 months after the RYGB intervention. Evaluation of catalase enzymatic activity in serum (nmol/min/mL) as part of the systemic antioxidant defense system. 12 months
Secondary Effect of the RYGB on body weight Changes in the body weight (kg) of patients 12 months after the RYGB intervention determined with an electronic scale 12 months
Secondary Effect of the RYGB on Body Mass Index (BMI) Changes in the BMI (kg/m^2) of patients 12 months after the RYGB intervention, measure by the formula: weight (kg) / [height (m)]^2 12 months
Secondary Effect of the RYGB on blood pressure Changes in Systolic/Diastolic Blood Pressure levels (SBP/DBP) (mmHg) measured with a sphygmomanometer 12 months
Secondary Effect of the RYGB on fasting Glucose levels Changes in fasting Glucose (mg/dL) of patients 12 months after the RYGB intervention, as a marker of glucose metabolism 12 months
Secondary Effect of the RYGB on fasting Insulin levels Changes in fasting Insulin (µU/mL) of patients 12 months after the RYGB intervention, as a marker of glucose metabolism 12 months
Secondary Effect of the RYGB on Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Index Changes in HOMA-IR Index of patients 12 months after the RYGB intervention, measured with the formula: [Fasting Glucose (mg/dL) x Fasting Insulin (µU/mL)]/405, as a marker of glucose metabolism 12 months
Secondary Effect of the RYGB on glycated hemoglobin (HbA1c) Changes in HbA1c (%) of patients 12 months after the RYGB intervention, as a marker of glucose metabolism 12 months
Secondary Effect of the RYGB on Total Cholesterol (TC) Changes in TC (mg/dL) of patients 12 months after the RYGB intervention, as a marker of the lipid profile 12 months
Secondary Effect of the RYGB on High Density Lipoprotein Cholesterol (HDLc) levels Changes in HDLc (mg/dL) of patients 12 months after the RYGB intervention, as a marker of the lipid profile 12 months
Secondary Effect of the RYGB on Low Density Lipoprotein Cholesterol (LDLc) levels Changes in LDLc (mg/dL) of patients 12 months after the RYGB intervention, as a marker of the lipid profile 12 months
Secondary Effect of the RYGB on Triglyceride (TG) levels Changes in TG (mg/dL) of patients 12 months after the RYGB intervention, as a marker of the lipid profile 12 months
Secondary Effect of the RYGB on high sensitivity C-Reactive Protein (hsCRP) levels Changes in hsCRP (mg/L) of patients 12 months after the RYGB intervention, as a marker of systemic inflammation 12 months
Secondary Effect of the RYGB on Interleukin-6 (IL6) levels Changes in IL6 (pg/mL) of patients 12 months after the RYGB intervention, as a marker of systemic inflammation 12 months
Secondary Effect of the RYGB on Interleukin-1 ß (IL1ß) levels Changes in IL1ß (pg/mL) of patients 12 months after the RYGB intervention, as a marker of systemic inflammation 12 months
Secondary Remission rate for pathologies related to metabolic syndrome 12 months after RYGB intervention Percentage of cases of remission for hypertension, hyperlipidemia and type 2 diabetes (T2D) after the intervention. 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2