Diastolic Dysfunction and Pulmonary Hypertension in T2DM With Microalbuminuria
ConditionDiabetes Mellitus Type 2
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 4 trial groupsGroup A: Group 1
Group B: Group 2
Group C: Group 3
Group D: Group 4
Trial outcomes
Primary outcomes
1
Diastolic Dysfunction and Pulmonary Hypertension Across Albuminuria Groups
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).
Time frame
At time of enrollment (single time-point cross-sectional assessment)Secondary outcomes
1
Correlation of Diastolic Dysfunction and PASP with Glycemic Control and Diabetes Duration
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.
Time frame
At time of enrollment (single time-point cross-sectional assessment)Sponsors and contacts
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Source ClinicalTrials.gov
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