Effects of Semaglutide on Blood Flow and Brain Barrier in Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates how semaglutide, a medication for type 2 diabetes, affects intracranial blood flow and blood-brain barrier permeability. Participants aged 40-65 with type 2 diabetes will be randomly assigned to receive either semaglutide or a placebo. The study will utilize magnetic resonance imaging to measure changes in blood flow and barrier permeability over one year. The goal is to understand the neuroprotective effects of semaglutide and its potential role in reducing stroke risk in patients with diabetes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men and women 40-65 years of age
2. Subjects with type-2 diabetes \>= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors
3. Medically stable
4. Has not received any investigational drug in the past 6 months
5. Willing to participate and sign informed consent.

Exclusion Criteria:

1. Contraindication to MRI or contrast agent
2. eGFR\<45 mL/min/1.73m2 (eGFR is a measurement of kidney function)
3. Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention)
4. Unable to perform home-glucose monitoring
5. Currently need more than 100 units of insulin daily
6. Uncontrolled hypertension with systolic blood pressure (SBP)\>180 mmHg or diastolic blood pressure (DBP)\>100 mmHg
7. LDL-C\>130 mg/dL or not on stable statin therapy in the past 6 months
8. Treatment with pioglitazone in the past 3 months
9. History of pancreatitis
10. History of myocardial infarction, stroke or transient ischemic attack
11. History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
12. Hypersensitivity to semaglutide or any of the product components
13. Participating in other clinical trial
14. Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or who are breastfeeding or who plan to become pregnant in the next 15 months.

Where it's running

• University of Washington - Harborview Medical Center
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Francis Kim, MD — University of Washington
• Study coordinator: Francis Kim, MD
• Email: fkim@u.washington.edu
• Phone: 206-744-8305

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.