Cardiac Function and Biomarkers in Patients With Obesity and Overweight (BEYOND)

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

Study Overview

• Status: Completed
• Conditions: Obesity & Overweight
• Intervention / Treatment: Drug: Weight loss with pharmacotherapy; Behavioral: Weight loss without pharmacotherapy

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • San Pedro Garza García, Nuevo León, Mexico, 66278
      • Hospital Zambrano Hellion, TecSalud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Behavioral: Weight loss without pharmacotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: TecSalud Investigación Clínica
• Collaborators: TecSalud; Fundación Santos y de la Garza Evia I.B.P

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): September 19, 2023
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Weight loss; Cardiovascular risk; Echocardiography; Cardiac MRI; Cardiac Function; GLP-1 receptor agonists
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss; Inflammation; Therapeutics; Drug Therapy
• Other Study ID Numbers: BEYOND (Company internal)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No