NCT05205005CompletedPhase 2/3
Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 2 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 20 Dec 2021
- Start date
- 25 May 2022
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Type 2 diabetes
- NCT number
- NCT05205005
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 24
- From 25 May 2022 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of hormone replacement therapy
Other illness
- Evidence of cardiac arrhythmias, unstable angina (or other cardiac event), heart failure or stroke in the last 12 months
- Evidence of uncontrolled hypertension, systolic blood pressure \> 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
- Active cancer
- 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
Lab values
- Evidence of chronic kidney disease stage IV or V (GFR \<30 mL/min)
Other
- Exclusion:
- Uncontrolled thyroid dysfunction (abnormal TSH within 3 months of study enrollment)
- 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
Who the study is looking for
- 45-74 years of age at the time of enrollment
- Diagnosis of T2D by a health care provider, confirmed by chart review
- HbA1c \<9% and fasting blood glucose \<200 mg/dL at screening visit
- Body mass index (BMI) 25-45 kg/m2
- Women should be postmenopausal (absence of menses for at least 1 year)
- Sedentary subjects (\<2 days/week of vigorous exercise)
- Willingness to follow up instructions provided by study team
Age in the registry: 45 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harry S. Truman Memorial, Columbia, MO Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.