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

29. april 2026 oppdatert av: Dr Ahmed Ibrahim Shoghy, Kafrelsheikh University

A Randomized, Allocation-concealed, Assessor-blinded, Parallel-group Trial Evaluating the Association Between Erectile Dysfunction and Left Ventricular Diastolic Dysfunction and Comparing the Effects of Tadalafil, SGLT2 Inhibitors, and Their Combination in Patients With Metabolic Syndrome.

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a prospective, randomized, allocation-concealed, assessor-blinded, parallel-group clinical trial conducted at the Faculty of Medicine, Kafrelsheikh University. The study investigates the association between erectile dysfunction (ED) and left ventricular diastolic dysfunction (LVDD) in men with metabolic syndrome, and evaluates the effects of different treatment strategies on both conditions.

A total of 60 male patients aged 41 to 73 years diagnosed with metabolic syndrome and erectile dysfunction will be enrolled and randomly assigned into three parallel groups (1:1:1). The first group will receive tadalafil 5 mg once daily, the second group will receive an SGLT2 inhibitor (dapagliflozin or empagliflozin 10 mg once daily), and the third group will receive a combination of both treatments. The duration of intervention is 3 months.

Randomization will be performed using permuted block randomization, with allocation concealment ensured by an independent sequence holder. Outcome assessors will be blinded to treatment allocation.

Baseline and follow-up assessments will include clinical evaluation, metabolic parameters, echocardiographic assessment of left ventricular diastolic function, and evaluation of erectile function using the International Index of Erectile Function (IIEF).

The primary outcome is the change in erectile function as assessed by IIEF score after 3 months of treatment. Secondary outcomes include changes in echocardiographic parameters of diastolic function, correlation between erectile function and diastolic dysfunction, and identification of predictors of improvement in erectile function.

The study aims to provide insight into the relationship between cardiovascular dysfunction and erectile dysfunction in patients with metabolic syndrome and to determine whether combined therapy offers additional benefits over monotherapy.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
    • Kafrelsheikh Governrate
      • Kafr ash Shaykh, Kafrelsheikh Governrate, Egypt, 33511
        • Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • * 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Tadalafil Group
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.
Legemiddel: Tadalafil 5 mg
Tadalafil 5 mg once daily for three months
Eksperimentell: SGLT2 inhibitors group
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.
Legemiddel: SGLT-2 inhibitor
SGLT2 inhibitors 10 mg orally once daily for three months
Andre navn:
  • Dapagliflozin
  • Empagliflozin
Eksperimentell: Combination therapy
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.
Legemiddel: Tadalafil plus SGLT2 inhibitors
Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in erectile function assessed by the International Index of Erectile Function (IIEF)
Tidsramme: Baseline and 3 months
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in left ventricular diastolic function assessed by echocardiographic parameters
Tidsramme: Baseline and 3 months
Left ventricular diastolic function will be assessed using specific echocardiographic parameters in accordance with ASE/EACVI guidelines, including E/e' ratio, isovolumic relaxation time (IVRT, ms), deceleration time (DT, ms), and pulmonary artery systolic pressure (PASP, mmHg). Each parameter will be measured at baseline and at 3 months, and analyzed individually as components of overall diastolic function to evaluate changes over time.
Baseline and 3 months
Correlation between changes in IIEF score and echocardiographic parameters
Tidsramme: Baseline and 3 months
Correlation between changes in erectile function assessed by the International Index of Erectile Function (IIEF-6) score (range: 1-30, higher scores indicate better erectile function) and changes in selected echocardiographic parameters of left ventricular diastolic function, including E/e' ratio, isovolumic relaxation time (IVRT, ms), deceleration time (DT, ms), and pulmonary artery systolic pressure (PASP, mmHg).
Baseline and 3 months
Predictors of change in IIEF score
Tidsramme: Baseline and 3 months
Identification of independent predictors of change in erectile function assessed by the International Index of Erectile Function (IIEF-6) score (range: 1-30, higher scores indicate better erectile function). Predictors include selected clinical variables (age, years; smoking status, categorical), metabolic parameters (waist circumference, cm; systolic and diastolic blood pressure, mmHg; fasting blood glucose, mg/dL; HDL cholesterol, mg/dL; triglycerides, mg/dL), and specific echocardiographic parameters (E/e' ratio, unitless; isovolumic relaxation time [IVRT], ms; deceleration time [DT], ms; pulmonary artery systolic pressure [PASP], mmHg).
Baseline and 3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kafrelsheikh University

Etterforskere

  • Studiestol: Reda B Bastawisy, MD (Professor), Faculty of medicine, Kafrelshiekh university
  • Studiestol: Wael A Haseeb, MD (Assistant professor), Faculty of medicine, Kafrelshiekh university
  • Studiestol: Mohamed G Abdelraouf, MD, Faculty of medicine, Kafrelshiekh university

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. mai 2025

Primær fullføring (Faktiske)

17. mars 2026

Studiet fullført (Faktiske)

17. mars 2026

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • METDDED-01
  • PACTR202604903325533 (Registeridentifikator: Pan African Clinical Trials Registry (PACTR))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (including baseline characteristics, outcome measures, and relevant clinical variables) will be made available upon reasonable request after publication of the study results.

IPD-delingstidsramme

Data will be available starting 6 months after publication and will remain available for up to 2 years.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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