Impact of Semaglutide on CD34+ EPC and Fat Derived MSC

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 facts

Study ID

NCT04126603

Run by

Sabyasachi Sen

People needed

10

Starts

2019-08-01

Expected to finish

2025-05-14

Last updated by the study team

2025-09-09

Who can join

Age: 20 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 20-90
• Diagnosed with Type 2 diabetes mellitus
• Body Mass Index (BMI) between 25.0-45.0 (both inclusive)
• eGFR ≥ 30 mL/min/1.73 m2 by MDRD
• HbA1C 6.5 - 12.0 %
• Subjects on lifestyle modification alone, or Metformin (0.5-2 grams), insulin, or in combination, in any doses of either Metformin or Insulin for at least 3 months prior to screening. 2 week washout of any other anti-hyperglycemic.
• Ability to provide informed consent (and document informed consent by signature) before any trial-related activities are conducted.
• Additional CVD risk factor such microalbuminuria or proteinuria (as defined by ADA, UACR > 30 mg/g), hypertension (labile, uncontrolled hypertension or controlled on anti-hypertensives) and left ventricular hypertrophy, left ventricular systolic or diastolic dysfunction, or an ankle brachial index [the ratio of the systolic blood pressure at the ankle to the systolic blood pressure in the arm] of less than 0.9, low HDL with hypertriglyceridemia (as defined by NCEP ATP III) , strong family history of CHD (as defined by NCEP ATP III and ATP IV).
• Retinal examination within last 2 years of enrollment, showing no proliferative retinopathy

You may not qualify if…

• Uncontrolled hyperglycemia with fasting glucose >300 mg/dL (>16.6 mmol/L)
• Liver disease with ALT, AST or ALP ≥ x3 ULN
• Known (recent) personal history of cerebral stroke or heart attack (myocardial infarction) within last 6 months
• Personal or family history of medullary thyroid cancer (MTC)
• Personal or family history of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
• GFR <30 mL/min/1.73 m2 by MDRD
• Prior surgery with chronic malabsorption (eg, bariatric) within last 1 year
• Clinically significant RBC disorders such as hemoglobinopathies
• Diagnosis of Type 1 diabetes mellitus or history of GAD antibody positive status
• Chronic use of high dose anti-inflammatory drugs for the last 3 months
• Beginning statin medications or change in statin dose within the past 1 month
• Starting use of high-dose steroid medication (100mg hydrocortisone or 40mg prednisone equivalent) within the last 1 month
• History of acute pancreatitis within the past 2 years
• Known or suspected allergy to GLP-1 agonists, excipients, or related products.
• Active smokers, >5 per day (at present)
• Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
• Women of child bearing potential who are not willing to use a contraceptive method to avoid pregnancy for the 16 weeks of study duration plus 2 months post treatment (for semaglutide washout).
• Women who are pregnant or breastfeeding
• Chronic or persistent alcohol or drug abuse
• Prisoners or subjects who are involuntarily incarcerated
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg. infectious disease) illness
• Participation in another trial with an investigational drug within 30 days prior to informed consent.
• Untreated or active hemorrhagic proliferative diabetic retinopathy
• Exclusionary Laboratory Findings
• Chronic Kidney Disease (CKD) stage 5 (estimated CrCl less than 15 mL/min)

Where it is running

• The GW Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Washington VA Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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