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
39 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
Researchers are evaluating the effects of semaglutide on intracranial blood flow and blood-brain barrier permeability in people with type-2 diabetes. This randomized, double-blind, placebo-controlled study aims to understand how semaglutide, an FDA-approved medication, may improve brain blood flow and reduce stroke risk in patients with diabetes. Preliminary data suggest that type-2 diabetes reduces brain arterial branches, indicating poorer blood flow, and semaglutide has shown stroke reduction benefits in this population. Participants will be randomly assigned to receive either semaglutide or a matching placebo for one year. Semaglutide is administered via a weekly auto-injector with a dose escalation starting at 0.25 mg, increasing to a target dose of 1 mg per week over 52 weeks. A diabetes care specialist will manage blood sugar levels to maintain HbA1C below 7.5% for both treatment groups to isolate semaglutide's effects on cerebral blood flow and blood-brain barrier function. During the study, participants will undergo magnetic resonance imaging at the beginning and after one year to measure intracranial blood flow and blood-brain barrier permeability. Additional assessments will include inflammatory markers. The study will monitor participants' health and glucose control throughout the year, with the primary outcomes focusing on brain circulation and barrier function after about 12 months of treatment.
CONDITIONS
Brief 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
- Diagnosis of type-2 diabetes for 3 or more years
- HbA1C between 7% and 10% while using blood sugar control medications such as insulin, metformin, sulfonylureas, or SGLT2 inhibitors
- Medically stable condition
- No investigational drug use in the past 6 months
- Willingness to participate and sign informed consent
You will not qualify if you...
- Contraindication to MRI or contrast agent
- Kidney function with eGFR less than 45 mL/min/1.73m2
- Current treatment with glucagon-like peptide-1 receptor agonists
- Unable to perform home glucose monitoring
- Need for more than 100 units of insulin daily
- Uncontrolled high blood pressure with systolic over 180 mmHg or diastolic over 100 mmHg
- LDL cholesterol above 130 mg/dL or not on stable statin therapy for past 6 months
- Treatment with pioglitazone in the past 3 months
- History of pancreatitis
- History of myocardial infarction, stroke, or transient ischemic attack
- Personal or family history of Medullary Thyroid Carcinoma or Multiple Endocrine Neoplasia syndrome type 2
- Allergy to semaglutide or its components
- Participation in another clinical trial
- Women of child-bearing potential who are pregnant, breastfeeding, planning pregnancy within 15 months, or not chemically/surgically sterilized or post-menopausal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive weekly injections of semaglutide or placebo for up to 52 weeks. A diabetes care specialist manages glucose control to maintain HbA1C below 7.5%.
Weekly visits for medication administration and monitoring
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here