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Completed

NCT Number: NCT07455630

Cardiac Function and Biomarkers in Patients With Obesity and Overweight

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Zambrano Hellion, TecSalud

San Pedro Garza García, Nuevo León, 66278, Mexico

About this study

Obesity is one of the leading global health issues, with a high impact on morbidity, mortality, and quality of life. In Mexico, the prevalence of obesity has significantly increased in the past two decades, ranking fifth worldwide. Obesity is strongly associated with other cardiovascular risk factors, including hypertension, diabetes, and dyslipidemia.

In obese individuals, a chronic low-grade inflammatory state and endothelial dysfunction contribute to adverse cardiovascular remodeling. These mechanisms-driven by adipose tissue inflammation, reduced nitric oxide bioavailability, and insulin resistance-can lead to myocardial hypertrophy, ventricular dilation, and impaired cardiac function. Structural and functional changes include increased left ventricular mass, larger right and left ventricular end-diastolic volumes, and subclinical diastolic dysfunction, as demonstrated by echocardiography and cardiac magnetic resonance imaging (MRI). Obesity-related adipose tissue dysfunction also induces an imbalance between anti-inflammatory adiponectin and pro-inflammatory adipocytokines, promoting myocardial and vascular remodeling.

Furthermore, epicardial adipose tissue exhibits high immune cell activity, including elevated expression of IL-1, IL-6, and TNF-α, contributing to the pathophysiology of heart failure with preserved ejection fraction (HFpEF). Alterations in gut microbiota (dysbiosis) also play a role in obesity-related inflammation by producing bacterial metabolites and lipopolysaccharides associated with endothelial activation and atherosclerotic plaque instability. Pharmacological interventions such as GLP-1 receptor agonists and SGLT2 inhibitors have shown potential benefits in reducing inflammation and improving cardiac metabolism. Weight loss-whether achieved through lifestyle modification, pharmacotherapy, or bariatric surgery-has been associated with improvements in hemodynamic load, blood pressure, and metabolic parameters. However, evidence regarding the reversibility of cardiac structural and functional changes remains insufficient. This study will prospectively evaluate adult patients (≥18 years) with overweight (BMI ≥25 kg/m²) or obesity (BMI ≥30 kg/m²) and at least one cardiovascular risk factor. Participants will receive individualized nutritional counseling and weight loss interventions (pharmacological or non-pharmacological) according to standard clinical practice at the TecSalud Institute of Cardiology and Vascular Medicine.

The primary objective is to determine whether significant weight loss (>10% reduction in body weight) results in measurable changes in cardiac morphology and function assessed by cardiac MRI and echocardiography. Secondary objectives include evaluating changes in inflammatory and cardiac biomarkers. An exploratory analysis will assess differences according to the weight loss strategy (pharmacological vs. non-pharmacological), including possible associations with gut microbiota composition. Ultimately, this study seeks to provide new evidence on the reversibility of obesity-related cardiac changes and the potential role of inflammatory and metabolic biomarkers in cardiovascular risk reduction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • No weight loss strategy prescribed
  • No cardiovascular risk factors

Treatment and study plan

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.

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.

Primary outcomes

  1. Left Ventricular Mass by Cardiac MRI

    Time frame: Baseline, 3 months, 6 months, and 9 months.

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

  2. Right Ventricular Mass by Cardiac MRI

    Time frame: Baseline, 3 months, 6 months, and 9 months.

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

  3. Left Ventricular Ejection Fraction

    Time frame: Baseline, 3 months, 6 months, and 9 months.

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

  4. Right Ventricular Ejection Fraction

    Time frame: Baseline, 3 months, 6 months, and 9 months.

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

  5. Diastolic Function Left Ventricle

    Time frame: Baseline, 3 months, 6 months, and 9 months.

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

  6. Diastolic Function Right Ventricle

    Time frame: Baseline, 3 months, 6 months, 9 months.

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

Secondary outcomes

  1. Growth Differentiation Factor 15 (GDF15)

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Serum GDF15 measured to assess metabolic stress and cardiovascular risk changes after weight reduction.

  2. Brain Natriuretic Peptide (BNP)

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Serum BNP measured to assess cardiac stress and functional changes associated with weight loss.

  3. High-Sensitivity Troponin I

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Serum high-sensitivity troponin I measured to evaluate myocardial injury or stress in relation to weight reduction.

  4. Galectin -3

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Concentration of serum Galectin-3 in relation to cardiac fibrosis associated with weight loss.

  5. Gut Microbiota Composition

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Fecal microbiota analysis using 16S rRNA sequencing of V3-V4 regions to assess changes in microbial diversity and composition associated with weight reduction

Sponsors and collaborators

Lead sponsor

TecSalud Investigación Clínica

Other

Collaborators

  • Fundación Santos y de la Garza Evia I.B.P

Registry information

Official study title

Effect of Weight Loss on Cardiac Function and Biomarkers in Patients With Cardiovascular Risk Factors, Obesity, or Overweight

Acronym: BEYOND

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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