Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2
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
| Condition(s) | Diabetes Mellitus, Type 2, Stroke (CVA) or Transient Ischemic Attack |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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 pres |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Lead sponsor | University of Washington |
| Locations | Seattle, Washington, United States |
| Start date | 2024-01-11 |
| NCT ID | NCT05780905 |
| Official listing | https://clinicaltrials.gov/study/NCT05780905 |