Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Impact of Semaglutide on CD34+ EPC and Fat Derived MSC

Lead Sponsor:

Sabyasachi Sen

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

20-90 years

Phase:

PHASE4

Brief 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. EP...

Detailed Description

Diabetes affects more than 9% of adults in the United States and this is projected to nearly double by 2025. Both diabetes and obesity are associated with endothelial dysfunction, oxidative stress, en...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • 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
  • Exclusion Criteria
  • 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)
  • Triglycerides \> 500 mg/dL
  • Low hematocrit (\<28 Units)

Exclusion

    Key Trial Info

    Start Date :

    August 1 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 14 2025

    Estimated Enrollment :

    10 Patients enrolled

    Trial Details

    Trial ID

    NCT04126603

    Start Date

    August 1 2019

    End Date

    May 14 2025

    Last Update

    September 9 2025

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    The GW Medical Faculty Associates

    Washington D.C., District of Columbia, United States, 20037

    2

    Washington VA Medical Center

    Washington D.C., District of Columbia, United States, 20422