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Diastolic Dysfunction and Pulmonary Hypertension in T2DM With Microalbuminuria

21 september 2026 uppdaterad av: Shady Ashraf Kassem, Assiut University

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Diabetes mellitus typ 2

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

120

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: shady Elsdfy, MD
Telefonnummer: 01028792280
E-post: elsdfyshady@gmail.com

Studieorter

Egypten
- Asyut Governorate
  - Asyut, Asyut Governorate, Egypten, 71515
    - Assiut University Hospital
    - Kontakt:
      
      Shady A Omar, MBBCh
      
      Telefonnummer: 01028792280
      
      E-post: elsdfyshady@gmail.com
    - Kontakt:
      
      Mohamed Faisal Adawy, Lecturer
      
      Telefonnummer: +20 10 1244126
      
      E-post: DR-m.faisal85m@aun.edu.eg

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: COHORT
Tidsperspektiv: CROSS_SECTIONAL

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Group 1 Group/Cohort Label: Healthy Controls Description: Non-diabetic adults, age- and sex-matched to the diabetic groups, confirmed by fasting glucose/HbA1c.
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).
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).
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).

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Diastolic Dysfunction and Pulmonary Hypertension Across Albuminuria Groups Tidsram: At time of enrollment (single time-point cross-sectional assessment)	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)

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Correlation of Diastolic Dysfunction and PASP with Glycemic Control and Diabetes Duration Tidsram: At time of enrollment (single time-point cross-sectional assessment)	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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Assiut University

Utredare

Huvudutredare: shady A Elsdfy, MD, Assiut University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

5 oktober 2026

Primärt slutförande (Beräknad)

5 oktober 2028

Avslutad studie (Beräknad)

5 juni 2029

Studieregistreringsdatum

Först inskickad

17 september 2026

Först inskickad som uppfyllde QC-kriterierna

21 september 2026

Första postat (Faktisk)

24 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)