Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes

• Status: Active, not recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development

Criteria

Inclusion Criteria:

1. 45-74 years of age at the time of enrollment

2. Diagnosis of T2D by a health care provider, confirmed by chart review

3. HbA1c <9% and fasting blood glucose <200 mg/dL at screening visit

4. Body mass index (BMI) 25-45 kg/m2

5. Women should be postmenopausal (absence of menses for at least 1 year)

6. Sedentary subjects (<2 days/week of vigorous exercise)

7. Willingness to follow up instructions provided by study team

Exclusion Criteria:

Exclusion:

1. Evidence of cardiac arrhythmias, unstable angina (or other cardiac event), heart failure or stroke in the last 12 months

2. Evidence of chronic kidney disease stage IV or V (GFR <30 mL/min)

3. 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

4. Diagnosis of chronic liver disease

5. Uncontrolled thyroid dysfunction (abnormal TSH within 3 months of study enrollment)

6. Active cancer

7. Current use of hormone replacement therapy

8. Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)

9. Current pregnancy or intent to become pregnant during the course of the study

10. Inability to swallow capsules

11. 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