RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

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

Quick Facts

Study Start:2024-01-11
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05780905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men and women 40-65 years of age
  2. 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. 3. Medically stable
  4. 4. Has not received any investigational drug in the past 6 months
  5. 5. Willing to participate and sign informed consent.
  1. 1. Contraindication to MRI or contrast agent
  2. 2. eGFR\<45 mL/min/1.73m2 (eGFR is a measurement of kidney function)
  3. 3. Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention)
  4. 4. Unable to perform home-glucose monitoring
  5. 5. Currently need more than 100 units of insulin daily
  6. 6. Uncontrolled hypertension with systolic blood pressure (SBP)\>180 mmHg or diastolic blood pressure (DBP)\>100 mmHg
  7. 7. LDL-C\>130 mg/dL or not on stable statin therapy in the past 6 months
  8. 8. Treatment with pioglitazone in the past 3 months
  9. 9. History of pancreatitis
  10. 10. History of myocardial infarction, stroke or transient ischemic attack
  11. 11. History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  12. 12. Hypersensitivity to semaglutide or any of the product components
  13. 13. Participating in other clinical trial
  14. 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.

Contacts and Locations

Study Contact

Francis Kim, MD
CONTACT
206-744-8305
fkim@u.washington.edu

Principal Investigator

Francis Kim, MD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington - Harborview Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Francis Kim, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-11
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-01-11
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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