Status:
COMPLETED
Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes
Lead Sponsor:
VA Office of Research and Development
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
45-64 years
Phase:
PHASE2
PHASE3
Brief 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 a...
Detailed Description
The prevalence of type 2 diabetes (T2D) continues to increase in the US. Importantly, T2D is widespread among Veterans. This T2D epidemic also contributes to the staggering rates of cardiovascular dis...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Exclusion:
- Evidence of cardiac arrhythmias, unstable angina (or other cardiac event), heart failure or stroke in the last 12 months
- Evidence of chronic kidney disease stage IV or V (GFR \<30 mL/min)
- 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
- 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
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05205005
Start Date
May 25 2022
End Date
July 31 2024
Last Update
May 2 2025
Active Locations (1)
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1
Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, United States, 65201-5275