Tests semaglutide effects on brain blood flow in type 2 diabetes
Tests semaglutide against placebo for brain blood flow in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
Key facts
- Where
- Seattle, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 65 years old?
Source: NCT05780905, who can take part
Where in United States
- University of Washington - Harborview Medical CenterSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Washington
- Trial code
- NCT05780905
- Record updated
- 5 June 2024
- Original description
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.Read full original descriptionShow less
Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
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.
Inclusion: Men and women 40-65 years of age; Subjects with type-2 diabetes >= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors; Medically stable; Has not received any investigational drug in the past 6 months; Willing to participate and sign informed consent.
Exclusion: Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention); Treatment with pioglitazone in the past 3 months; Uncontrolled hypertension with systolic blood pressure (SBP)>180 mmHg or diastolic blood pressure (DBP)>100 mmHg; History of pancreatitis; History of myocardial infarction, stroke or transient ischemic attack; History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); Hypersensitivity to semaglutide or any of the product components; eGFR<45 mL/min/1.73m2 (eGFR is a measurement of kidney function); Unable to perform home-glucose monitoring; LDL-C>130 mg/dL or not on stable statin therapy in the past 6 months; Contraindication to MRI or contrast agent; Currently need more than 100 units of insulin daily; Participating in other clinical trial; 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.