Diabetes Mellitus, Type 2 Clinical Trial
— ADAM17Official title:
Targeting ADAM17 Activity for Correction of Vascular Insulin Resistance in Type 2 Diabetes
The objective of this project is to determine the extent to which administration of the dietary supplement phosphatidylserine (PS), a competitive inhibitor of ADAM17 sheddase activity, effects vascular function and insulin-stimulated leg blood flow in subjects with T2D.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | November 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 64 Years |
Eligibility | Inclusion Criteria: 1. Men and women with a BMI of 25-39 kg/m2, who are 45-64 years of age at randomization. 2. T2D patients classified based on physician diagnosis. 3. No vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled. Exclusion Criteria: 1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke 2. History of chronic renal or hepatic disease 3. Active cancer 4. Autoimmune diseases 5. Immunosuppressant therapy 6. Hormone replacement therapy 7. Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women) 8. Current tobacco use 9. Pregnancy 10. Bodyweight change =5% within the last 6 months |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri- NextGen Clinical Translational Science Unit | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Insulin-stimulated blood flow | Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound. | baseline and 4 weeks | |
Secondary | Change in Vascular function | Flow mediated dilation (FMD) in arm and passive limb movement (PLM) in the leg. Blood flow measures will be performed non-invasively via Ultrasound. | Baseline and 4 weeks |
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