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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Kafrelsheikh Governrate
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Kafr ash Shaykh、Kafrelsheikh Governrate、エジプト、33511
- Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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
他の名前：
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in erectile function assessed by the International Index of Erectile Function (IIEF)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in left ventricular diastolic function assessed by echocardiographic parameters
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディチェア：Reda B Bastawisy, MD (Professor)、Faculty of medicine, Kafrelshiekh university
- スタディチェア：Wael A Haseeb, MD (Assistant professor)、Faculty of medicine, Kafrelshiekh university
- スタディチェア：Mohamed G Abdelraouf, MD、Faculty of medicine, Kafrelshiekh university
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 泌尿生殖器疾患
- 生殖器疾患
- 心血管疾患
- 精神障害
- 生殖器疾患、男性
- 男性の泌尿生殖器疾患
- 心臓疾患
- 代謝疾患
- グルコース代謝障害
- インスリン抵抗性
- 高インスリン症
- 心室機能不全
- 性機能障害、生理
- 性機能障害、心理学
- 栄養および代謝疾患
- メタボリック・シンドローム
- 心室機能不全、左
- 勃起不全
- 薬物の生理学的影響
- 薬理作用の分子機構
- 血糖降下剤
- ピリジン
- 複素環化化合物、1リング
- 複素環化化合物
- 複素環化化合物、2リング
- 複素環化化合物、融合リング
- 薬理学的行動
- 化学作用と用途
- インドール
- インドールアルカロイド
- 複素環化化合物、3リング
- カルボリン
- タダラフィル
- ナトリウム-グルコース輸送体 2 阻害剤
- Empagliflozin
- ダパグリフロジン
その他の研究ID番号
- METDDED-01
- PACTR202604903325533 (レジストリ識別子：Pan African Clinical Trials Registry (PACTR))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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米国FDA規制医薬品の研究
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