Primary outcomeMean· First Visit at Baseline and Last Visit at 24 weeks
CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio
| Group | Value (ratio) | Spread |
|---|---|---|
| Group A Placebo | 0.10 | 0.06 |
| Group B Active | 0.23 | 0.16 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataImpact of Semaglutide on CD34+ EPC and Fat Derived MSC
NCTNCT04126603 (opens ClinicalTrials.gov in a new tab)Other idNCR191206
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 10 participants (actual)
- Sponsor
- Sabyasachi Sen · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 1 Aug 2019
- Primary completion
- 25 Oct 2023
- Completion
- 14 May 2025
- First posted
- 15 Oct 2019
- Last update posted
- 9 Sept 2025
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2020202220242026
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- SemaglutideDrug
- PlacebosDrug
Arms2
Placebo comparator
Group A Placebo
Placebo.
Active comparator
Group B Active
Semaglutide
Primary outcomes4
Outcomes the sponsor listed as primary.
CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
Number of CD34+ EPCs per total MNC ratio. Please note CD34+ cells is a progenitor cell marker derived from mononuclear cells (MNCs).
CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
The distance the CD34+ EPC migrates in response to SDF1 alpha 10ng. This assess the mobility of stem cells such as CD34+ EPC and the distance it traveled would lead us to understand how medication therapy changes stem cell behavior and its functionality.
Gene Expression of CD34+ Endothelial Progenitor Cell Number
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
we will evaluate mRNA gene expression of endothelial Progenitor cell with catalase, KDR, NOS3,SOD2, TNF-alpha which is normalized to 18s. Fold change of particular genes in hematopoietic stem cells between baseline and terminal visit at week 24 were analyzed.
CD34+ Endothelial Cell Colony Formation Unit (CFU)
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
CFU count of CD34+ EPCs
Secondary outcomes(9)
Gene Expression of Subcutaneous Adipose Cell
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
We will evaluate mRNA gene expression for mature fat and fat related transcription factors.
Arterial Stiffness: Pulse Wave Analysis Augmentation Index
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
Vessel health is assessed by looking at Arterial stiffness. Augmentation index (AI) is defined as the ratio of the augmentation pressure to the pulse pressure, times 100, to give a percentage. We used Vascular Flow and wave measurement equipment, SphygmoCor Central Pressure system from AtCor. The higher the values the higher the cardiovascular risk.
Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure. The higher the values the higher the cardiovascular risk.
Arterial Stiffness: Pulse Wave Analysis Augmentation Index 75
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
Vessel health is assessed by looking at Arterial stiffness. Augmentation index (AI) is defined as the ratio of the augmentation pressure to the pulse pressure, times 100, to give a percentage. Augmentation index 75 normalizes this value to an estimate of the AI at a heart rate of 75bpm. We used Vascular Flow and wave measurement equipment, SphygmoCor Central Pressure system from AtCor. The higher the values the higher the cardiovascular risk.
Body Composition: BMI
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
Body mass index measured using Bio metric Impedance Scale
Body Composition: Body Fat Percent
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
Percent of Body Fat measured using Bio metric Impedance Tanita Scale
Biochemistry: Hemoglobin A1C (HbA1c)
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
HbA1c percent
Hip to Waist Ratio
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
Ratio of Hip to Waist
Biochemistry: Low-density Lipoprotein (LPL) Cholesterol Over High-density Lipoprotein (HDL) Ratio
Time frame · First Visit at Baseline and Last Visit at 24 weeks
Registry description
ratio of LDL over HDL cholesterol
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· First Visit at Baseline and Last Visit at 24 weeks
CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient
| Group | Value (micrometer (um)) | Spread |
|---|---|---|
| Group A Placebo | 708.5 | 357.09 |
| Group B Active | 377.75 | 440.17 |
Primary outcomeMean· First Visit at Baseline and Last Visit at 24 weeks
Gene Expression of CD34+ Endothelial Progenitor Cell Number
| Group | Value (Fold change) | Spread |
|---|---|---|
| Group A Placebo | -0.64 | 0.72 |
| Group B Active | 0.5 | 1.52 |
Primary outcomeMean· First Visit at Baseline and Last Visit at 24 weeks
CD34+ Endothelial Cell Colony Formation Unit (CFU)
| Group | Value (CFUs/mL) | Spread |
|---|---|---|
| Group A Placebo | 12.0 | 4.77 |
| Group B Active | 5.10 | 1.56 |
Secondary and other outcome results(4)
Secondary outcome· First Visit at Baseline and Last Visit at 24 weeks
Gene Expression of Subcutaneous Adipose Cell
| Group | Value |
|---|---|
| Group A Placebo | not posted |
| Group B Active | not posted |
Secondary outcomeMean· First Visit at Baseline and Last Visit at 24 weeks
Arterial Stiffness: Pulse Wave Analysis Augmentation Index
| Group | Value (percent) | Spread |
|---|---|---|
| Group A Placebo | 23.80 | 11.82 |
| Group B Active | 29.67 | 4.16 |
Secondary outcomeMean· First Visit at Baseline and Last Visit at 24 weeks
Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure
| Group | Value (Millimeters of mercury) | Spread |
|---|---|---|
| Group A Placebo | 10.80 | 7.69 |
| Group B Active | 15.33 | 2.89 |
Secondary outcomeMean· First Visit at Baseline and Last Visit at 24 weeks
Arterial Stiffness: Pulse Wave Analysis Augmentation Index 75
| Group | Value (percent) | Spread |
|---|---|---|
| Group A Placebo | 23.20 | 15.80 |
| Group B Active | 32.00 | 7.55 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group A PlaceboPlacebo. Placebos: Placebo injection | 0 / 5 | 0 / 5 | 0 / 5 |
| Group B ActiveSemaglutide: 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 | 0 / 5 | 0 / 5 | 0 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years up to 90 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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)
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