Impact of Semaglutide on CD34+ EPC and Fat Derived MSC

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Sabyasachi Sen
Study ID
NCT04126603
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
  • Placebos — DRUG
    Placebo injection

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Aug 2025
Primary completion
Oct 25, 2023
Completion
May 14, 2025

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Group A Placebo
    Placebo.
  • Active Comparator: Group B Active
    Semaglutide

Primary Outcome Measure

CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio [ Time Frame: First Visit at Baseline and Last Visit at 24 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
The GW Medical Faculty AssociatesWashington D.C.District of Columbia20037-
Washington VA Medical CenterWashington D.C.District of Columbia20422-

Related coverage on Hipa.ai

Find similar trials in Washington D.C., DC

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
The GW Medical Faculty Associates· Washington D.C., DCWashington VA Medical Center· Washington D.C., DC

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