Actively Recruiting
Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
Led by University of Washington · Updated on 2024-06-05
50
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
Novo Nordisk A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
A human subjects research study, the primary purpose of which is to assess the EFFECTS OF SEMAGLUTIDE ON INTRACRANIAL BLOOD FLOW AND BLOOD-BRAIN BARRIER PERMEABILITY IN TYPE-2 DIABETES (T2D) through testing of the intervention on patients in a clinical setting. The study will randomize subjects with diabetes to either semaglutide or matching placebo. Magnetic resonance images will be primary endpoint measured at baseline and at one year to assess effect of this FDA approved medication. Given the available evidence supporting the neuroprotective effect of this drug class and stroke reduction with semaglutide, and the investigators preliminary data showing that T2D had significantly reduced total number of distal arterial branches in the brain than non-T2D, the investigators expect treatment with semaglutide will be associated with improved intracranial blood flow condition.
CONDITIONS
Official Title
Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 40-65 years of age
- Diagnosed with type-2 diabetes for 3 or more years
- HbA1C between 7% and 10% while on blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors
- Medically stable
- Has not taken any investigational drug in the past 6 months
- Willing to participate and sign informed consent
You will not qualify if you...
- Contraindication to MRI or contrast agent
- Kidney function measured by eGFR less than 45 mL/min/1.73m2
- Currently treated with glucagon-like peptide-1 receptor antagonists
- Unable to perform home glucose monitoring
- Need more than 100 units of insulin daily
- Uncontrolled high blood pressure (systolic >180 mmHg or diastolic >100 mmHg)
- LDL cholesterol above 130 mg/dL or not on stable statin therapy for past 6 months
- Treatment with pioglitazone in past 3 months
- History of pancreatitis
- History of heart attack, stroke, or transient ischemic attack
- History or family history of Medullary Thyroid Carcinoma or Multiple Endocrine Neoplasia syndrome type 2
- Allergic to semaglutide or any study product components
- Currently participating in another clinical trial
- Women of child-bearing potential who are pregnant, breastfeeding, or planning pregnancy within 15 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Washington - Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
F
Francis Kim, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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