NCT05780905RecruitingPhase 4
Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
Source: ClinicalTrials.gov · Last updated 5 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 10 Mar 2023
- Start date
- 11 Jan 2024
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- University of Washington
- Diseases
- Stroke, Type 2 diabetes
- NCT number
- NCT05780905
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 11 Jan 2024 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention)
- Treatment with pioglitazone in the past 3 months
Other illness
- 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
Lab values
- 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
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington - Harborview Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.