Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
Recruiting
Phase 4Interventional Study
Diabetes Mellitus, Type 2Stroke (CVA) or Transient Ischemic Attack
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Screening
Participants needed
50 (estimated)
Sponsor
University of Washington · Other
Who this trial is looking for
This trial is looking for adults with type 2 diabetes to study the effects of semaglutide on blood flow in the brain. Participants will either receive semaglutide or a placebo and have MRI scans taken over one year.
Are You a Good Fit for This Trial?
Must be takingInsulinMetforminSulfonylureasSGLT2 inhibitors
Rules you outHistory of myocardial infarctionStrokeTransient Ischemic AttackHypersensitivity to semaglutideMedullary Thyroid CarcinomaMultiple Endocrine Neoplasia syndrome type 2
You may be able to join if
I am between 40 and 65 years old
I have been diagnosed with type 2 diabetes for at least 3 years
My HbA1C is between 7% and 10%
I am using medications for blood sugar control
I am medically stable
I have not taken any investigational drug in the past 6 months
I am willing to participate and sign the consent form
You may not be able to join if
I cannot have an MRI or contrast agent
My kidney function (eGFR) is below 45 mL/min/1.73m2
I am currently treated with a GLP-1 receptor antagonist
I cannot monitor my blood glucose at home
I take more than 100 units of insulin daily
I have uncontrolled high blood pressure
My LDL cholesterol is above 130 mg/dL and I'm not on stable statin therapy
I have a history of pancreatitis
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 endpo…
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.
Trial Locations
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Eligibility 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 …
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.
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