Association Between Diastolic Dysfunction and Erectile Dysfunction and the Effect of Tadalafil and SGLT2 Inhibitors on Them in Men With Metabolic Syndrome (METDDED)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Kafrelsheikh Governrate
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Kafr ash Shaykh, Kafrelsheikh Governrate, 이집트, 33511
- Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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Tadalafil 5 mg once daily for three months
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실험적: 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.
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SGLT2 inhibitors 10 mg orally once daily for three months
다른 이름들:
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실험적: 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.
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Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in erectile function assessed by the International Index of Erectile Function (IIEF)
기간: Baseline and 3 months
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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.
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Baseline and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in left ventricular diastolic function assessed by echocardiographic parameters
기간: Baseline and 3 months
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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.
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Baseline and 3 months
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Correlation between changes in IIEF score and echocardiographic parameters
기간: Baseline and 3 months
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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).
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Baseline and 3 months
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Predictors of change in IIEF score
기간: Baseline and 3 months
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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).
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Baseline and 3 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Reda B Bastawisy, MD (Professor), Faculty of medicine, Kafrelshiekh university
- 연구 의자: Wael A Haseeb, MD (Assistant professor), Faculty of medicine, Kafrelshiekh university
- 연구 의자: Mohamed G Abdelraouf, MD, Faculty of medicine, Kafrelshiekh university
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 생식기 질환
- 심혈관 질환
- 정신 질환
- 생식기 질환, 남성
- 남성 비뇨 생식기 질환
- 심장 질환
- 대사 질환
- 포도당 대사 장애
- 인슐린 저항성
- 고인슐린증
- 심실 기능 장애
- 성기능 장애, 생리
- 성기능 장애, 심리적
- 영양 및 대사 질환
- 대사 증후군
- 심실 기능 부전, 왼쪽
- 발기부전
- 약물의 생리적 효과
- 약리작용의 분자 메커니즘
- 혈당강하제
- 피리딘
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 약리학 적 행동
- 화학 작용 및 용도
- 인돌
- 인돌 알칼로이드
- 이종 사이 클릭 화합물, 3- 링
- 카르 볼린
- 타다라필
- 나트륨-포도당 수송체 2 억제제
- Empagliflozin
- Dapagliflozin
기타 연구 ID 번호
- METDDED-01
- PACTR202604903325533 (레지스트리 식별자: Pan African Clinical Trials Registry (PACTR))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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