Diastolic Dysfunction and Pulmonary Hypertension in T2DM With Microalbuminuria

September 21, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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.

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diastolic Dysfunction and Pulmonary Hypertension Across Albuminuria Groups
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation of Diastolic Dysfunction and PASP with Glycemic Control and Diabetes Duration
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: shady A Elsdfy, MD, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04-2026-100520
  • SCCREIRB-MEDICIASSIUT-GU-001-2 (Other Identifier: Assiut Faculty of Medicine Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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