Semaglutide and Vascular Regeneration

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation Criteria

Inclusion Criteria:

1. Adults ≥ 18 years of age who meet one of the following Health Canada indications to receive subcutaneous semaglutide injections:

* Documented T2D with inadequate glycemic control
* Body mass index (BMI) ≥ 30 kg/m\^2 (obesity)
* BMI ≥ 27 kg/m\^2 (overweight) and at least one weight-related comorbidity, such as hypertension, dyslipidemia, or obstructive sleep apnea
2. AND meet one of the following ASCVD criteria:

* History of ASCVD:

* Documented coronary artery disease
* Documented cerebrovascular or carotid disease
* Documented peripheral artery disease
* No ASCVD but has 2 or more of the following risk factors:

* Cigarette smoker or stopped smoking within 3 months of screening
* Persistent hypertension (defined as office blood pressure ≥ 140/90 mmHg) or currently on antihypertensive medications
* BMI ≥ 27 kg/m\^2
* estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m\^2
* Treated or untreated dyslipidemia
* Triglyceride ≥ 2.0 mmol/L
* HDL-C ≤ 1.0 mmol/L for men or ≤ 1.3 mmol/L for women
* High sensitivity C-reactive protein (hsCRP) ≥ 2.0 mg/L
* Documented micro- or macro-albuminuria
* Self-identified South Asian ethnicity

Exclusion Criteria:

* Female subjects who are pregnant, planning pregnancy, or breastfeeding
* HbA1c \> 11.0 %
* Currently on a GLP-1RA or previously taken a GLP-1RA
* Personal or family history of medullary thyroid carcinoma
* Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
* New York Heart Association class IV symptoms of heart failure
* Known history of severe liver disease (e.g. Child-Pugh Class B or C)
* White blood cell count ≥ 15 x 10\^9/L
* Active infectious disease requiring antibiotic or anti-viral agents
* Known acquired immunodeficiency syndrome such as HIV
* On oral steroid therapy (e.g. prednisone or other corticosteroids) or other immunosuppressive agents (e.g. methotrexate)
* Any malignancy not considered cured (except basal cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
* Any clinically significant or unstable medical condition that might limit one's ability to complete the study or comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease