Phase 3
N=24
Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT05205005 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Glygocalyx Integrity - Perfused Boundary Region — 0.11; -0.16 Delta micrometers (mcm)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Endocalyx (Drug); Placebo (Drug)
- Age
- Adult · 45+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glygocalyx Integrity - Perfused Boundary Region |
0.11; -0.16 | — |
| SECONDARY Brachial Artery Flow Mediated Dilation |
2.93; 2.14; 3.20; 1.87 | — |
| SECONDARY Insulin-stimulated Leg Blood Flow |
5.98; 16.93; 2.97; 9.55 | — |
| SECONDARY Femoral Artery Flow Mediated Dilation |
2.93; 2.14; 3.20; 1.87 | — |
Summary
The prevalence of type 2 diabetes (T2D) continues to increase in the US, with 26.8 million adults carrying a diagnosis. Importantly, T2D is widespread in the Veteran population. This epidemic of T2D also contributes to the staggering rates of cardiovascular disease and cardiovascular mortality. Lifestyle modifications, including increased physical activity, are recommended as first-line therapy for the management of T2D. Unfortunately, patients with T2D exhibit diminished vascular adaptations to exercise. The proposed project will test the overall hypothesis that degradation of the endothelial glycocalyx, a characteristic feature of T2D, precludes shear stress mechanotransduction and consequent exercise-induced vascular adaptations. As such, the investigators pose that restoration of the endothelial glycocalyx via dietary supplementation of glycocalyx precursors will potentiate vascular adaptations to exercise in Veterans with T2D.
Eligibility Criteria
Inclusion Criteria
- 45-74 years of age at the time of enrollment
- Diagnosis of T2D by a health care provider, confirmed by chart review
- HbA1c 180 mmHg and/or diastolic blood pressure > 110 mmHg on more than 2 occasions in the past 12 months or at screening visit
- Diagnosis of chronic liver disease
- Uncontrolled thyroid dysfunction (abnormal TSH within 3 months of study enrollment)
- Active cancer
- Current use of hormone replacement therapy
- Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
- Current pregnancy or intent to become pregnant during the course of the study
- Inability to swallow capsules
- Known allergies to any of the compounds in the supplement: glucosamine extract, fucoidan extract, olive extract, artichoke extract, red and white grapes extract, melon concentrate, hyaluronic acid
Data sourced from ClinicalTrials.gov (NCT05205005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.