Semaglutide and Vascular Regeneration

Sponsor
Canadian Medical and Surgical Knowledge Translation Research Group
Study ID
NCT05870462
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Pen Injector — DRUG
    * 0.25 mg/week (non-therapeutic dose) during Weeks 1-4 * 0.50 mg/week during Weeks 5-8 * 1.0 mg/week during Weeks 9-24 Participants experiencing side effects (e.g. nausea, stomach pain, constipation, diarrhea, vomiting) at the maximum dose (1.0 mg/week) may be down-titrated to 0.50 mg/week. Participants who had been receiving a dipeptidyl peptidase 4 (DPP-4) inhibitor (sitagliptin, saxagliptin, linagliptin, alogliptin) will stop taking their DPP-4 inhibitor upon randomization to this arm.

Study Details

SEMA-VR is a prospective, randomized, 6-month long, open-label study of semaglutide. Approximately 100 participants with type 2 diabetes and/or obesity will be randomized (1:1) to receive semaglutide at escalating doses (up to 1.0 mg/week) or usual care without semaglutide for 6 months. The goal of this trial is to understand how semaglutide exerts cardio-protective effects in people with type 2 diabetes and/or obesity. The main question it aims to answer is: • Does semaglutide treatment preserve or increase the number of vessel-repairing cells circulating in the blood? Participants will: * Be allocated to receive either semaglutide or usual care for 6 months * Provide a blood sample at the baseline visit and another blood sample at the 6-month visit Researchers will compare participants receiving semaglutide to those receiving usual care for any differences in the 6-month change in the number of vessel-repairing cells in the blood.

Key Dates

Start date
Apr 29, 2023
Status verified
Jul 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Semaglutide
    Participants will receive once-weekly semaglutide subcutaneous injection \[Ozempic\] at escalating doses from 0.25 mg/week, 0.5 mg/week, to 1.0 mg/week.
  • No Intervention: Usual care
    Participants will continue to receive other usual medications, rehabilitation, procedures, and interventions as recommended by their healthcare providers.

Primary Outcome Measure

Changes in the mean frequency (%) of circulating ALDHhiSSClow primitive progenitor cells in individuals treated with semaglutide versus usual care for 6 months [ Time Frame: Baseline to 6 months post-randomization ]

Central Contacts

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