Clinical trial

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

Recruiting now · Phase 4 · 1 countries · Registry ID NCT05780905

Recruiting nowPhase 4Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionDiabetes Mellitus, Type 2, Stroke (CVA) or Transient Ischemic Attack

Full registry criteria

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.

Treatments and study arms

Semaglutide Auto-Injector

Drug

Subjects have an equal chance of receiving semaglutide or placebo. Which treatment subjects receive is decided at random by a computer (purely by chance, like the tossing of a coin). Neither subjects, Study Site personnel nor image reviewers will know which treatment subjects are assigned to. The study drug must be taken weekly. The subject's other medications may be changed by the study's un-blinded Endocrinologist. At baseline subject will receive and take home 0.25mg injector for use 3 more times. They will be given a 0.5mg injector and a 1mg injector for use beginning 5 and 9 weeks from baseline respectively. The target dose for subjects is 1mg per week up to the 52 week treatment duration.

Placebo

Other

Placebo

Primary outcomes

Intracranial blood flow (IBF)Approximately 12 Months

measured as total length and number of distal vessels

bloodbrain barrier KtransApproximately 12 Months

measured by dynamic contrast-enhanced MRI

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Washington - Harborview Medical Center🇺🇸 Seattle, Washington, United States

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Francis Kim, MDContact

Email · Call 206-744-8305

Francis Kim, MDPrincipal Investigator