Impact of Semaglutide on CD34+ EPC and Fat Derived MSC
Status:
Recruiting
Trial end date:
2021-11-30
Target enrollment:
Participant gender:
Summary
The Investigator is trying to ascertain whether an FDA approved medication of T2DM,
Semaglutide, can improve the number, function and gene expression of subjects CD34+
endothelial progenitor cells. EPCs are the source of cells protecting the inner lining of
blood vessels and improving their survivability will improve cardiovascular outcome as high
glucose environment of diabetes are toxic to these EPC Cells.
Improve mitochondrial metabolism of Mesenchymal Stem Cell from subcutaneous fatty tissue,
leading to weight loss. Improve overall vascular health by reducing inflammation.
The investigator will enroll 40 subjects with T2DM who are only on metformin. The study
consists of 4 visits to the GW MFA, including screening visit. Subjects will be recruited
from across the DMV area, and prescreened over the phone or in clinic, and then invited for
an in-person screening visit at the GW MFA to determine eligibility. If eligible, subject
will be enrolled into one of two study Arms, active semaglutide 1 mg or Placebo. This study
will include an up titration of study drug. From week 0-4 subject will be on 0.25 mg/week,
from week 5-8 subject will take 0.5mg/week, and week 9 to 24 subject will take 1 mg/week of
Semaglutide or Placebo.
During the regular 3 visits subject will have their vital measured, body composition assessed
using Tanita scale, arterial stiffness measured and blood drawn for EPC cells analysis and
standard of care labs. At visit 1 and visit 3, fat biopsy will be done on the belly area to
acquire 2-3 grams of fat tissue. Screening will take place at week -2, Visit1 at week 0,
Visit 2 at week 8, Visit 3 at week 24. Subject will receive follow-up phone calls on week 4,
week16 and week 28.