Vascular Aging Clinical Trial
Official title:
Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
The proposed study will assess the ability of a naturally occurring sugar to improve the function of arteries with age. Overall, the proposed research project has the long-term potential to influence clinical practice guidelines by establishing a novel, easy to deliver, cost-effective therapy for treating age-associated arterial dysfunction and reducing the risk of cardiovascular disease with age.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years to 79 Years |
Eligibility |
Inclusion Criteria: - women must be postmenopausal - body mass index (BMI) <40 kg/m2 - weight stable in the prior 3 months - absence of clinical disease as determined by medical history, physical examination, blood and urine chemistries, ankle-brachial index, and a graded exercise stress test with monitoring of blood pressure and 12-lead ECG |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado, Boulder Clinical Translational Research Center | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Boulder |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arterial Stiffness | Arterial pulse wave velocity | 12 weeks | No |
Primary | nitric-oxide mediated endothelium-dependent dilation | flow-mediated dilation and forearm blood flow responses to acetylcholine in the presence and absence of N'-monomethyl-L-arginine | 12 weeks | No |
Secondary | Systemic oxidative stress and inflammation | circulating markers of oxidative stress and inflammation | 12 weeks | No |
Secondary | Endothelial cell oxidative stress and inflammation | inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells | 12 weeks | No |
Secondary | Insulin sensitivity | intravenous glucose tolerance test | 12 weeks | No |
Secondary | Endothelial cell autophagic flux | 12 weeks | No |
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