Association Between Diastolic Dysfunction and Erectile Dysfunction and the Effect of Tadalafil and SGLT2 Inhibitors on Them in Men With Metabolic Syndrome

NCT07563647 | Completed Phase 4

• 2 other identifiers: METDDED-01PACTR202604903325533
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic syndrome is associated with an increased risk of cardiovascular disease and is commonly accompanied by erectile dysfunction and subclinical cardiac dysfunction. Erectile dysfunction and left ventricular diastolic dysfunction may share common underlying mechanisms, including endothelial dysfunction and microvascular impairment. This study aims to investigate the association between erectile dysfunction and left ventricular diastolic dysfunction in men with metabolic syndrome, and to evaluate the effects of different treatment strategies, including tadalafil and SGLT2 inhibitors, on both erectile function and cardiac diastolic function. Participants will be randomly assigned to receive tadalafil, an SGLT2 inhibitor, or a combination of both for a duration of three months. Clinical, echocardiographic, and functional assessments will be performed at baseline and after treatment. The results of this study may improve understanding of the link between cardiovascular and sexual dysfunction and help guide therapeutic approaches in this patient population.

Conditions

Erectile Dysfunction; Left Ventricular Diastolic Dysfunction; Metabolic Syndrome

Keywords

Tadalafil; SGLT2 inhibitors; Diastolic function; Echocardiography; Endothelial dysfunction; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Change in erectile function assessed by the International Index of Erectile Function (IIEF)

  Change in erectile function assessed by the International Index of Erectile Function (IIEF-6). The IIEF-6 is a validated questionnaire with scores ranging from 1 to 30, where higher scores indicate better erectile function. The outcome measure will be the change in IIEF-6 score from baseline to 3 months after treatment.

  Baseline and 3 months

Secondary Outcomes (3)

• Change in left ventricular diastolic function assessed by echocardiographic parameters

  Baseline and 3 months

• Correlation between changes in IIEF score and echocardiographic parameters

  Baseline and 3 months

• Predictors of change in IIEF score

  Baseline and 3 months

Study Arms (3)

Tadalafil Group

ACTIVE COMPARATOR

Participants received tadalafil 5 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment.

Drug: Tadalafil 5 mg

SGLT2 inhibitors group

EXPERIMENTAL

Participants received SGLT2 inhibitors (dapagliflozin or empagliflozin) 10 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment.

Drug: SGLT-2 inhibitor

Combination therapy

EXPERIMENTAL

Participants received combination therapy with tadalafil 5 mg once daily plus SGLT2 inhibitors 10 mg once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment.

Drug: Tadalafil plus SGLT2 inhibitors

Interventions

Tadalafil 5 mg DRUG

Tadalafil 5 mg once daily for three months

Tadalafil Group

SGLT-2 inhibitor DRUG

SGLT2 inhibitors 10 mg orally once daily for three months

Also known as: Dapagliflozin, Empagliflozin

SGLT2 inhibitors group

Tadalafil plus SGLT2 inhibitors DRUG

Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months

Combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged ≥18 years
• History of sexual activity within the past 6 months
• Erectile dysfunction for at least 3 months (defined as IIEF-6 score ≤25)
• Diagnosed with metabolic syndrome

You may not qualify if:

• \* Left ventricular systolic dysfunction (EF less than 50%)
• Recent myocardial infarction (within 1 month)
• Moderate to severe valvular heart disease (stenosis or regurgitation)
• Renal failure (eGFR \<20 ml/min)
• Major pelvic surgery
• Significant central nervous system injury (e.g., spinal cord injury)
• Endocrine disorders (hypothyroidism, hypogonadism)
• Premature ejaculation
• Current balanitis or urogenital infections
• History of orthostatic hypotension
• Any contraindications to tadalafil or SGLT2 inhibitors

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy

Kafr ash Shaykh, Kafrelsheikh Governrate, 33511, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction; Ventricular Dysfunction, Left; Metabolic Syndrome

Interventions

Tadalafil; Sodium-Glucose Transporter 2 Inhibitors; dapagliflozin; empagliflozin

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Reda B Bastawisy, MD (Professor)

  Faculty of medicine, Kafrelshiekh university

  STUDY CHAIR

• Wael A Haseeb, MD (Assistant professor)

  Faculty of medicine, Kafrelshiekh university

  STUDY CHAIR

• Mohamed G Abdelraouf, MD

  Faculty of medicine, Kafrelshiekh university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Cardiology Resident)

Model Details: This is a randomized, parallel-group interventional study in which eligible male patients with metabolic syndrome will be allocated into separate treatment arms. Each group will receive a specific intervention (e.g., tadalafil, SGLT2 inhibitors, or combination). Participants will remain in their assigned group throughout the study period without crossover. Outcomes, including erectile function and left ventricular diastolic function assessed by echocardiography, will be compared between groups.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 4, 2026
• Study Start: May 5, 2025
• Primary Completion: March 17, 2026
• Study Completion: March 17, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available starting 6 months after publication and will remain available for up to 2 years.
• Access Criteria: Access will be granted to qualified researchers upon reasonable request, subject to approval by the principal investigator and institutional ethics committee, and after signing a data sharing agreement.

Locations

EG (1)