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Cardiac Function and Biomarkers in Patients With Obesity and Overweight

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07455630
Acronym
BEYOND
Enrollment
30
Registered
2026-03-06
Start date
2023-06-20
Completion date
2024-09-30
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity & Overweight

Keywords

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

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.

Detailed description

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.

Interventions

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.

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.

Sponsors

TecSalud Investigación Clínica
Lead SponsorOTHER
TecSalud
CollaboratorUNKNOWN
Fundación Santos y de la Garza Evia I.B.P
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Right Ventricular Mass by Cardiac MRIBaseline, 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.
Left Ventricular Ejection FractionBaseline, 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.
Right Ventricular Ejection FractionBaseline, 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.
Left Ventricular Mass by Cardiac MRIBaseline, 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.
Diastolic Function Left VentricleBaseline, 3 months, 6 months, and 9 months.Left ventricular diastolic function measuring E/A ratio using echocardiography to assess functional improvement after weight loss.
Diastolic Function Right VentricleBaseline, 3 months, 6 months, 9 months.Right ventricular diastolic function measuring E/A ratio using echocardiography to assess functional improvement after weight loss.

Secondary

MeasureTime frameDescription
Growth Differentiation Factor 15 (GDF15)Baseline, 3 months, 6 months, and 9 monthsSerum GDF15 measured to assess metabolic stress and cardiovascular risk changes after weight reduction.
Brain Natriuretic Peptide (BNP)Baseline, 3 months, 6 months, and 9 monthsSerum BNP measured to assess cardiac stress and functional changes associated with weight loss.
High-Sensitivity Troponin IBaseline, 3 months, 6 months, and 9 monthsSerum high-sensitivity troponin I measured to evaluate myocardial injury or stress in relation to weight reduction.
Galectin -3Baseline, 3 months, 6 months, and 9 monthsConcentration of serum Galectin-3 in relation to cardiac fibrosis associated with weight loss.
Gut Microbiota CompositionBaseline, 3 months, 6 months, and 9 monthsFecal microbiota analysis using 16S rRNA sequencing of V3-V4 regions to assess changes in microbial diversity and composition associated with weight reduction

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026