Effects of Sulodexide on damaged endothelial Glycocalyx in pAtients with Diabetes Mellitus type II; Reversing damage. - Sugar

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004043-35-NL

Enrollment

Registered

2007-02-07

Start date

2007-02-16

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus type II with and without microalbuminuria, damaged glycocalyx

Interventions

Trade Name: Sulodexide Product Name: Sulodexide Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Male - Age between 18 and 65 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - immunosuppressive drugs - Serious previous illnesses - Coagulation disorders - Primary dyslipidemias - BMI > 30 kg/m2 - Hypertension (systolic >140 mm Hg or diastolic >90 mm Hg)

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary Objective(s): The second objective of the present study is to measure the effect of sulodexide in patients with DM type II with and without microalbuminuria on biochemical parameters, including micro-albuminuria and HBA1c. ;Main Objective: Primary Objective: Aim of the study is to investigate whether sulodexide treatment reverses damage of the systemic glycocalyx in patients with DM type II. The effect of sulodexide will be addressed in this prospective study measuring systemic and local glycocalyx volume, vascular permeability as well as vascular function in patients with DM type II who have microalbuminuria and in patients with DM type II who do not have microalbuminuria compared to healthy controls, matched for age and sex. ;Primary end point(s): Main study parameter/endpoint The change from baseline to end of the study in systemic glycocalyx volume. Secondary study parameters/endpoints (if applicable) The change from baseline to end of the study in local sublingual glycocalyx volume, vascular permeability and endothelial function in all patients. The percentage change from baseline to end of the study in microalbuminuria in patients with DM type II who have microalbuminuria. Other study parameters (if applicable) Body weight Baseline values of glucose, HbA1c, lipid profile, albumin, creatinin, liver enzymes, CRP.	—

Measure

Time frame

Secondary Objective: Secondary Objective(s): The second objective of the present study is to measure the effect of sulodexide in patients with DM type II with and without microalbuminuria on biochemical parameters, including micro-albuminuria and HBA1c. ;Main Objective: Primary Objective: Aim of the study is to investigate whether sulodexide treatment reverses damage of the systemic glycocalyx in patients with DM type II. The effect of sulodexide will be addressed in this prospective study measuring systemic and local glycocalyx volume, vascular permeability as well as vascular function in patients with DM type II who have microalbuminuria and in patients with DM type II who do not have microalbuminuria compared to healthy controls, matched for age and sex. ;Primary end point(s): Main study parameter/endpoint The change from baseline to end of the study in systemic glycocalyx volume. Secondary study parameters/endpoints (if applicable) The change from baseline to end of the study in local sublingual glycocalyx volume, vascular permeability and endothelial function in all patients. The percentage change from baseline to end of the study in microalbuminuria in patients with DM type II who have microalbuminuria. Other study parameters (if applicable) Body weight Baseline values of glucose, HbA1c, lipid profile, albumin, creatinin, liver enzymes, CRP.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026