Diastolic Dysfunction and Pulmonary Hypertension in T2DM With Microalbuminuria
Diastolic Dysfunction and Pulmonary Hypertension in Type 2 Diabetes Mellitus With Microalbuminuria in Upper Egypt
This is a cross-sectional observational study comparing echocardiographic markers of left ventricular diastolic function and pulmonary artery systolic pressure among healthy controls and patients with type 2 diabetes mellitus, stratified by albuminuria status (normal, microalbuminuria, macroalbuminuria) according to KDIGO 2024 criteria. The study is being conducted in Upper Egypt and aims to characterize the relationship between the albuminuria spectrum and cardiac diastolic/pulmonary vascular involvement in type 2 diabetes, alongside glycemic control and diabetes duration.
研究概览
地位
条件
详细说明
Type 2 diabetes mellitus (T2DM) is associated with subclinical cardiac abnormalities that often precede overt heart failure. Diabetic cardiomyopathy is characterized early by impaired left ventricular relaxation and increased filling pressures, detectable echocardiographically as left ventricular diastolic dysfunction (LVDD), frequently before any drop in ejection fraction. Pulmonary hypertension (PH) is increasingly recognized as a comorbid finding in diabetic populations, potentially arising secondary to diastolic dysfunction, microvascular disease, or both.
Albuminuria is a graded marker of generalized microvascular endothelial dysfunction in diabetes, classified by KDIGO 2024 criteria into normal-to-mildly-increased, moderately increased (microalbuminuria), and severely increased (macroalbuminuria) categories, corresponding to progressive cardiovascular and renal risk. While microalbuminuria in isolation has been linked to adverse cardiopulmonary outcomes, the relationship between the full albuminuria spectrum and echocardiographic indices of diastolic dysfunction and PH has not been well characterized, particularly against a non-diabetic control benchmark, in an Upper Egyptian population.
This protocol compares standard transthoracic echocardiographic markers of diastolic dysfunction and PH, alongside glycemic control (HbA1c) and diabetes duration, across four groups: healthy controls and T2DM patients with normal albuminuria, microalbuminuria, and macroalbuminuria.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：shady Elsdfy, MD
- 电话号码：01028792280
- 邮箱：elsdfyshady@gmail.com
学习地点
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Asyut Governorate
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Asyut、Asyut Governorate、埃及、71515
- Assiut University Hospital
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接触：
- Shady A Omar, MBBCh
- 电话号码：01028792280
- 邮箱：elsdfyshady@gmail.com
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接触：
- Mohamed Faisal Adawy, Lecturer
- 电话号码：+20 10 1244126
- 邮箱：DR-m.faisal85m@aun.edu.eg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients recruited from Cardiology and Internal Medicine/Endocrinology outpatient clinics and inpatient wards at Assiut University Hospital, Upper Egypt, along with age- and sex-matched non-diabetic controls.
描述
Inclusion Criteria:
- Four groups will be recruited: (1) healthy, non-diabetic controls, age- and sex-matched to the diabetic groups; (2) T2DM with normal albuminuria (KDIGO A1, urine ACR <30 mg/g); (3) T2DM with microalbuminuria (KDIGO A2, ACR 30-300 mg/g); (4) T2DM with macroalbuminuria (KDIGO A3, ACR >300 mg/g). Diabetic groups: adult patients (≥18 years) with an established diagnosis of type 2 diabetes mellitus. Control group: adults (≥18 years) without diabetes (confirmed by fasting glucose/HbA1c), age- and sex-matched to the diabetic groups. All groups: willingness and ability to provide informed consent.
Exclusion Criteria:
Type 1 diabetes or secondary forms of diabetes; known primary valvular heart disease (moderate or greater); prior myocardial infarction or established coronary artery disease with regional wall motion abnormality; reduced ejection fraction (EF < 50%) on screening echocardiography; chronic kidney disease stage ≥4 or dialysis dependence; known chronic lung disease or other secondary causes of pulmonary hypertension unrelated to left heart disease; atrial fibrillation or other rhythm disturbance precluding reliable diastolic assessment; pregnancy. Note: systemic hypertension is not an exclusion criterion, given its high prevalence as a diabetes comorbidity; it will instead be recorded and analyzed as a covariate.
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学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：CROSS_SECTIONAL
队列和干预
团体/队列 |
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Group 1
Group/Cohort Label: Healthy Controls Description: Non-diabetic adults, age- and sex-matched to the diabetic groups, confirmed by fasting glucose/HbA1c. |
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Group 2
Group/Cohort Label: T2DM with Normoalbuminuria Description: Adult patients with type 2 diabetes mellitus and normal urinary albumin-to-creatinine ratio (KDIGO A1, ACR <30 mg/g). |
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Group 3
Group/Cohort Label: T2DM with Microalbuminuria Description: Adult patients with type 2 diabetes mellitus and moderately increased albuminuria (KDIGO A2, ACR 30-300 mg/g). |
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Group 4
Group/Cohort Label: T2DM with Macroalbuminuria Description: Adult patients with type 2 diabetes mellitus and severely increased albuminuria (KDIGO A3, ACR >300 mg/g). |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Diastolic Dysfunction and Pulmonary Hypertension Across Albuminuria Groups
大体时间：At time of enrollment (single time-point cross-sectional assessment)
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Title: Prevalence of left ventricular diastolic dysfunction (LVDD) Description: Percentage of participants with LVDD, defined by the 2016 ASE/EACVI algorithm using transthoracic Doppler echocardiography, compared between the control, T2DM-normoalbuminuria, T2DM-microalbuminuria and T2DM-macroalbuminuria groups. Time Frame: At enrollment (single study visit) Outcome 2 Title: Grade of LVDD Description: Percentage of participants in each LVDD grade (grade I, II, III), graded according to the 2016 ASE/EACVI guidelines using transthoracic Doppler echocardiography, compared between the four groups. Time Frame: At enrollment (single study visit) Outcome 3 Title: Frequency of pulmonary hypertension (PH) Description: Percentage of participants with echocardiographic pulmonary hypertension, defined per 2022 ESC/ERS criteria using transthoracic Doppler echocardiography, compared between the four groups. Time Frame: At enrollment (single study visit). |
At time of enrollment (single time-point cross-sectional assessment)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Correlation of Diastolic Dysfunction and PASP with Glycemic Control and Diabetes Duration
大体时间：At time of enrollment (single time-point cross-sectional assessment)
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Correlation of diastolic dysfunction parameters and pulmonary artery systolic pressure (PASP) with HbA1c and diabetes duration within the diabetic subgroups, using Pearson or Spearman correlation as appropriate. Multivariable regression will be used to adjust for hypertension and other covariates influencing these associations across all four groups. |
At time of enrollment (single time-point cross-sectional assessment)
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合作者和调查者
调查人员
- 首席研究员：shady A Elsdfy, MD、Assiut University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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