Cardiac Function and Biomarkers in Patients With Obesity and Overweight

NCT07455630 | Completed

• 1 other identifier: BEYOND
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a major public health problem worldwide and an established risk factor for cardiovascular disease. In individuals with obesity or overweight, systemic inflammation and endothelial dysfunction contribute to myocardial hypertrophy, ventricular remodeling, and alterations in cardiac morphology and function. Weight loss has been shown to improve metabolic and hemodynamic parameters; however, evidence regarding structural and functional cardiac reversibility remains limited. This prospective single-center cohort study aims to evaluate changes in cardiac morphology and function (assessed by cardiac magnetic resonance imaging and echocardiography), as well as changes in inflammatory and cardiac biomarkers, in patients with obesity or overweight and cardiovascular risk factors who achieve at least a 10% reduction in body weight through pharmacological or non-pharmacological interventions.

Conditions

Obesity & Overweight

Keywords

Cardiovascular risk; Cardiac Function; Cardiac MRI; Echocardiography; Inflammation; Weight loss; GLP-1 receptor agonists

Outcome Measures

Primary Outcomes (6)

• Left Ventricular Mass by Cardiac MRI

  Measurement of left ventricular mass using cardiac magnetic resonance imaging to assess structural changes associated with weight loss.

  Baseline, 3 months, 6 months, and 9 months.

• Right Ventricular Mass by Cardiac MRI

  Measurement of right ventricular mass using cardiac magnetic resonance imaging to assess structural changes associated with weight loss.

  Baseline, 3 months, 6 months, and 9 months.

• Left Ventricular Ejection Fraction

  Assessment of left ventricular systolic function using cardiac MRI and echocardiography to detect functional changes associated with weight reduction.

  Baseline, 3 months, 6 months, and 9 months.

• Right Ventricular Ejection Fraction

  ssessment of right ventricular systolic function using cardiac MRI and echocardiography to detect functional changes associated with weight reduction.

  Baseline, 3 months, 6 months, and 9 months.

• Diastolic Function Left Ventricle

  Left ventricular diastolic function measuring E/A ratio using echocardiography to assess functional improvement after weight loss.

  Baseline, 3 months, 6 months, and 9 months.

• Diastolic Function Right Ventricle

  Right ventricular diastolic function measuring E/A ratio using echocardiography to assess functional improvement after weight loss.

  Baseline, 3 months, 6 months, 9 months.

Secondary Outcomes (5)

• Growth Differentiation Factor 15 (GDF15)

  Baseline, 3 months, 6 months, and 9 months

• Brain Natriuretic Peptide (BNP)

  Baseline, 3 months, 6 months, and 9 months

• High-Sensitivity Troponin I

  Baseline, 3 months, 6 months, and 9 months

• Galectin -3

  Baseline, 3 months, 6 months, and 9 months

• Gut Microbiota Composition

  Baseline, 3 months, 6 months, and 9 months

Study Arms (1)

Overweight and Obese Adults with Cardiovascular Risk Factors

This cohort includes adult participants (≥18 years) with overweight (BMI ≥25 kg/m²) or obesity (BMI ≥30 kg/m²) and at least one cardiovascular risk factor. All participants will receive weight loss interventions, including lifestyle modifications, nutritional counseling, and/or pharmacological treatment, and will be followed longitudinally to assess changes in cardiac morphology and function, inflammatory and cardiac biomarkers, and gut microbiota composition.

Drug: Weight loss with pharmacotherapy; Behavioral: Weight loss without pharmacotherapy

Interventions

Weight loss with pharmacotherapy DRUG

Some participants may receive pharmacological treatment for weight loss as prescribed by their treating physician. All interventions are part of standard clinical care and are recorded for observational analysis.

Overweight and Obese Adults with Cardiovascular Risk Factors

Weight loss without pharmacotherapy BEHAVIORAL

Participants receive individualized lifestyle counseling, including diet modification, physical activity recommendations, and behavioral strategies to achieve weight reduction. All interventions are part of standard clinical care and are documented for observational analysis.

Overweight and Obese Adults with Cardiovascular Risk Factors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with overweight or obesity and at least one cardiovascular risk factor who have been prescribed a pharmacologic or non-pharmacologic weight reduction strategy.

You may qualify if:

• Age \>= 18 years
• BMI \> 25 kg/m2
• At least one cardiovascular risk factor
• Has been prescribed a pharmacologic or non-pharmacologic weight loss strategy
• Signed informed consent

You may not qualify if:

• No weight loss strategy prescribed
• No cardiovascular risk factors

Sponsors & Collaborators

• TecSalud Investigación Clínica: lead
• TecSalud: collaborator
• Fundación Santos y de la Garza Evia I.B.P: collaborator

Study Sites (1)

Hospital Zambrano Hellion, TecSalud

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

The biospecimens collected and retained in this study include peripheral blood samples for plasma, serum, and mononuclear cell isolation, which will be used for biochemical, hematological, inflammatory, cardiac, and metabolic biomarker analyses, including high-sensitivity troponin I, BNP, CRP, TNF-α, FABP4, GDF15, collagen biomarkers, and immunophenotyping of mononuclear cells by flow cytometry. Blood samples will be aliquoted and stored at -80°C for future analyses. Stool samples will be collected using OMNIgene-GUT® OMR 200 stabilizer tubes for gut microbiota analysis, with DNA extracted and processed following standardized protocols, including 16S rRNA sequencing of the V3-V4 regions using Illumina® MiSeq, and bioinformatic analysis using mothur for sequence cleaning and taxonomic classification. Derived plasma, serum, mononuclear cell aliquots, and fecal DNA will be retained for future exploratory analyses related to immune function, metabolism, inflammation, and microbiota.

MeSH Terms

Conditions

Obesity; Overweight; Inflammation; Weight Loss

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Body Weight Changes

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

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

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: March 6, 2026
• Study Start: June 20, 2023
• Primary Completion: September 19, 2023
• Study Completion: September 30, 2024
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)