Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-22 @ 7:25 AM
Study NCT ID:
NCT04126603
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2019-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Semaglutide on CD34+ EPC and Fat Derived MSC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ssen1@gwu.edu', 'phone': '202-994-8560', 'title': 'Sabyasachi Sen', 'organization': 'George Washington University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'description': 'Patients monitored by laboratory results every 2 months and questions of general well-being', 'eventGroups': [{'id': 'EG000', 'title': 'Group A Placebo', 'description': 'Placebo.\n\nPlacebos: Placebo injection', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Number of CD34+ EPCs per total MNC ratio. Please note CD34+ cells is a progenitor cell marker derived from mononuclear cells (MNCs).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '708.5', 'spread': '357.09', 'groupId': 'OG000'}, {'value': '377.75', 'spread': '440.17', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '530.75', 'spread': '405.53', 'groupId': 'OG000'}, {'value': '3232.33', 'spread': '2553.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', '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.', 'unitOfMeasure': 'micrometer (um)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gene Expression of CD34+ Endothelial Progenitor Cell Number', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'Catalase', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'KDR', 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'NOS3', 'categories': [{'measurements': [{'value': '-1.88', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'SOD2', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'TNF-A', 'categories': [{'measurements': [{'value': '3.37', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', '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.', 'unitOfMeasure': 'Fold change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'CD34+ Endothelial Cell Colony Formation Unit (CFU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First Visit', 'categories': [{'measurements': [{'value': '12.0', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Last Visit', 'categories': [{'measurements': [{'value': '12.25', 'spread': '11.67', 'groupId': 'OG000'}, {'value': '23.75', 'spread': '4.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'CFU count of CD34+ EPCs', 'unitOfMeasure': 'CFUs/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gene Expression of Subcutaneous Adipose Cell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'We will evaluate mRNA gene expression for mature fat and fat related transcription factors.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to freezer power failure in the lab, the fat samples were degraded and could not saved for cryo preservation. As a result, qpcr and histology could not carried out due to lack of samples in frozen state.'}, {'type': 'SECONDARY', 'title': 'Arterial Stiffness: Pulse Wave Analysis Augmentation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '23.80', 'spread': '11.82', 'groupId': 'OG000'}, {'value': '29.67', 'spread': '4.16', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '24.00', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '32.00', 'spread': '14.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', '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.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '10.80', 'spread': '7.69', 'groupId': 'OG000'}, {'value': '15.33', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '8.00', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '16.50', 'spread': '13.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure. The higher the values the higher the cardiovascular risk.', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Arterial Stiffness: Pulse Wave Analysis Augmentation Index 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '23.20', 'spread': '15.80', 'groupId': 'OG000'}, {'value': '32.00', 'spread': '7.55', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '27.00', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '36.50', 'spread': '14.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', '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.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Composition: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '34.95', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '44.33', 'spread': '7.75', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '36.00', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '40.77', 'spread': '4.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Body mass index measured using Bio metric Impedance Scale', 'unitOfMeasure': 'Kilogram per meter squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Composition: Body Fat Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '41.10', 'spread': '5.98', 'groupId': 'OG000'}, {'value': '50.70', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '39.47', 'spread': '9.09', 'groupId': 'OG000'}, {'value': '49.87', 'spread': '6.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Percent of Body Fat measured using Bio metric Impedance Tanita Scale', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Biochemistry: Hemoglobin A1C (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '7.67', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '7.80', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '6.55', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '7.10', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'HbA1c percent', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hip to Waist Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '0.96', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Ratio of Hip to Waist', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Biochemistry: Low-density Lipoprotein (LPL) Cholesterol Over High-density Lipoprotein (HDL) Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'OG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'classes': [{'title': 'First visit', 'categories': [{'measurements': [{'value': '2.43', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '1.98', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'ratio of LDL over HDL cholesterol', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A Placebo', 'description': 'Placebos: Placebo injection'}, {'id': 'FG001', 'title': 'Group B Active', 'description': 'Semaglutide: 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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '10 patients were enrolled at GWU', 'preAssignmentDetails': 'Only 10 patients from GWU were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A Placebo', 'description': 'Metformin + Placebo.\n\nPlacebos: Placebo injection'}, {'id': 'BG001', 'title': 'Group B Active', 'description': 'Metformin + Semaglutide: 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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '72'}, {'value': '59', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '73'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': 'NA', 'comment': 'not reported', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'not reported', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-25', 'size': 5791918, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-14T16:03', 'hasProtocol': True}, {'date': '2021-08-25', 'size': 3648243, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-14T16:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2019-10-07', 'resultsFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-20', 'studyFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Number of CD34+ EPCs per total MNC ratio. Please note CD34+ cells is a progenitor cell marker derived from mononuclear cells (MNCs).'}, {'measure': 'CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', '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.'}, {'measure': 'Gene Expression of CD34+ Endothelial Progenitor Cell Number', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', '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.'}, {'measure': 'CD34+ Endothelial Cell Colony Formation Unit (CFU)', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'CFU count of CD34+ EPCs'}], 'secondaryOutcomes': [{'measure': 'Gene Expression of Subcutaneous Adipose Cell', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'We will evaluate mRNA gene expression for mature fat and fat related transcription factors.'}, {'measure': 'Arterial Stiffness: Pulse Wave Analysis Augmentation Index', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', '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.'}, {'measure': 'Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure. The higher the values the higher the cardiovascular risk.'}, {'measure': 'Arterial Stiffness: Pulse Wave Analysis Augmentation Index 75', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', '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.'}, {'measure': 'Body Composition: BMI', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Body mass index measured using Bio metric Impedance Scale'}, {'measure': 'Body Composition: Body Fat Percent', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Percent of Body Fat measured using Bio metric Impedance Tanita Scale'}, {'measure': 'Biochemistry: Hemoglobin A1C (HbA1c)', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'HbA1c percent'}, {'measure': 'Hip to Waist Ratio', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'Ratio of Hip to Waist'}, {'measure': 'Biochemistry: Low-density Lipoprotein (LPL) Cholesterol Over High-density Lipoprotein (HDL) Ratio', 'timeFrame': 'First Visit at Baseline and Last Visit at 24 weeks', 'description': 'ratio of LDL over HDL cholesterol'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': '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.\n\nImprove mitochondrial metabolism of Mesenchymal Stem Cell from subcutaneous fatty tissue, leading to weight loss. Improve overall vascular health by reducing inflammation.\n\nThe 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.\n\nDuring 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.', 'detailedDescription': "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, endothelial cell inflammation, cardiovascular pro-thrombotic states and are the most common causes of kidney disease and blindness. Endothelium and its progenitors, meaning endothelial progenitor cells (EPCs), are an established surrogate of cardiovascular risk outcome measures. EPCs have been defined as CD34+ cells thereby identifying a defined homogenous population from a heterogeneous peripheral blood derived mononuclear cells.\n\nThe investigator and others, have previously shown that EPCs can act as a cellular biomarker that is more reliable than serum based markers for CVD risk estimation. It was demonstrated that gene expression in EPCs change within two weeks of an intervention such as aerobic exercise. On the other-hand serum biomarkers usually take much longer time to change secondary to an intervention. Also the paracrine effect of damaged endothelium is secondary to gene expression changes that have been altered in the progenitor cells several months ahead of discernible changes in serum based biomarkers such as endothelium based inflammatory markers. When serum inflammatory markers are elevated that may mean that the endothelium is already damaged/ inflamed and possibly irreversibly\n\nEPC are the future endothelium, therefore studying EPCs may help us to predict the effect of an intervention (such as a medication or exercise) on the future of endothelium and endothelial function. In normal course of events, the EPCs transition to mature endothelium and replace endothelial cells after normal cell death cycle or programmed apoptosis. However, unfortunately, type 2 diabetes being a pro-inflammatory, high ROS disease process, chronically depletes the EPC population by up-regulating apoptotic pathways mediated by p53. As an apoptotic condition, hyperglycemia even mild (such as prediabetes) affects immature EPCs more so than the mature endothelium. Hence, the damaged and inflamed mature endothelium, with time, is not replaced by EPCs as the progenitor pool has been depleted. This maybe one of the reasons why vascular damage takes 4-5 years to develop following onset of hyperglycemia.\n\nIt is known that GLP1 agonist has positive effect on oxidative stress, and endothelial function, therefore semaglutide can be hypothesized to have a positive effect on EPC and endothelium and possibly reduce fat inflammation. It may also reduce transformation of multipotent mesenchymal stem cells (MSCs) towards more fat formation (prevent adipogenesis) which may explain weight reducing capability seen in semaglutide studies (SUSTAIN trials). The use of CD34+ cells and MSCs as a biomarker is novel. One can obtain CD34+ cells from a simple peripheral blood draw (without doing an invasive procedure). The blood is then sorted for a homogenous progenitor/stem cell population. Role of CD34+ve EPCs in vascular biology, heart regeneration and collateral vessel formation as an endothelial progenitor cell is well established. It's role as a biomarker is also being developed. CD34+ cells are the most studied cardiovascular progenitor cells and its efficacy has been established in chronic diseases such as diabetes by Werner et al in 2005.\n\nSimilarly, one can obtain fat derived MSC from fat biopsies, particularly from overweight and obese individuals. Diabetes is not only a state of endothelial dysfunction, it is also a state of fat hyperplasia, insulin resistance at the level of muscle and fat and is associated with high ROS. Improvement of endothelial health is most likely paired with healthier fat. A state of healthier fat will be associated with healthy adipocytes, pre-adipocytes and healthy MSCs.\n\nThe weight reducing data from SUSTAIN 6 trial using semaglutide at 0.5mg and 1.0mg, is encouraging. It has also shown significant improvement in blood pressure and HbA1C within 8 weeks and definitely by 16 weeks even at a lower FDA approved dose of 0.5mg once a week.\n\nThese finding prompted the investigator team to use MSC as a fat surrogate and EPCs as an endothelial surrogate to establish a cellular mechanism behind the clinical trial findings. It may also shed light on cross-talk between these two important insulin responsive tissues that contribute towards cardiovascular health.\n\nThe Investigators believe EPC is the ideal cellular vascular outcome biomarker while MSC is the ideal adipocyte health bio-marker. Based on recently published data on saxagliptin's effect on EPC of subjects with Type 2 Diabetes, the investigators are confident that EPC is a robust endothelial marker with quick changes in number, function and gene expression, after appropriate intervention.\n\nThe purpose of the present study is to study the effect of a long-acting GLP-1 agonist, over a period of 24 weeks and understand how it influences two different yet related cell types such as endothelium and adipocyte, both of which are key players in insulin resistance/sensitivity in the body.\n\nStudy Hypotheses:\n\nThe investigator hypothesize that GLP1 agonists, like semaglutide, have a positive effect on the EPC number, function, targeted gene expression, arterial stiffness and endothelium specific inflammatory markers.\n\nAdditionally, the investigator hypothesize that semaglutide therapy will reduce adipogenesis and increase bone and cartilage formation by increasing cellular metabolism, as evidenced by increased mitochondrial biogenesis and increased cellular oxygen consumption rate (OCR, measured by SeaHorse)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age 20-90\n* Diagnosed with Type 2 diabetes mellitus\n* Body Mass Index (BMI) between 25.0-45.0 (both inclusive)\n* eGFR ≥ 30 mL/min/1.73 m2 by MDRD\n* HbA1C 6.5 - 12.0 %\n* 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.\n* Ability to provide informed consent (and document informed consent by signature) before any trial-related activities are conducted.\n* 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).\n* Retinal examination within last 2 years of enrollment, showing no proliferative retinopathy\n\nExclusion Criteria\n\n* Uncontrolled hyperglycemia with fasting glucose \\>300 mg/dL (\\>16.6 mmol/L)\n* Liver disease with ALT, AST or ALP ≥ x3 ULN\n* Known (recent) personal history of cerebral stroke or heart attack (myocardial infarction) within last 6 months\n* Personal or family history of medullary thyroid cancer (MTC)\n* Personal or family history of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)\n* GFR \\<30 mL/min/1.73 m2 by MDRD\n* Prior surgery with chronic malabsorption (eg, bariatric) within last 1 year\n* Clinically significant RBC disorders such as hemoglobinopathies\n* Diagnosis of Type 1 diabetes mellitus or history of GAD antibody positive status\n* Chronic use of high dose anti-inflammatory drugs for the last 3 months\n* Beginning statin medications or change in statin dose within the past 1 month\n* Starting use of high-dose steroid medication (100mg hydrocortisone or 40mg prednisone equivalent) within the last 1 month\n* History of acute pancreatitis within the past 2 years\n* Known or suspected allergy to GLP-1 agonists, excipients, or related products.\n* Active smokers, \\>5 per day (at present)\n* Any other clinical condition that would jeopardize patients safety while participating in this clinical trial\n* 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).\n* Women who are pregnant or breastfeeding\n* Chronic or persistent alcohol or drug abuse\n* Prisoners or subjects who are involuntarily incarcerated\n* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg. infectious disease) illness\n* Participation in another trial with an investigational drug within 30 days prior to informed consent.\n* Untreated or active hemorrhagic proliferative diabetic retinopathy\n\nExclusionary Laboratory Findings\n\n* Chronic Kidney Disease (CKD) stage 5 (estimated CrCl less than 15 mL/min)\n* Triglycerides \\> 500 mg/dL\n* Low hematocrit (\\<28 Units)'}, 'identificationModule': {'nctId': 'NCT04126603', 'briefTitle': 'Impact of Semaglutide on CD34+ EPC and Fat Derived MSC', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Impact of Semaglutide (Long Acting GLP1 Agonist) on Peripheral Blood Derived CD34+ Endothelial Cells (EPCs) and Subcutaneous Fat Derived Mesenchymal Stromal Cells ( MSCs) in Type 2 Diabetes Subjects', 'orgStudyIdInfo': {'id': 'NCR191206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group A Placebo', 'description': 'Placebo.', 'interventionNames': ['Drug: Placebos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B Active', 'description': 'Semaglutide', 'interventionNames': ['Drug: Semaglutide']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Group B Active']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo injection', 'armGroupLabels': ['Group A Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'The GW Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington VA Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sabyasachi Sen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Sabyasachi Sen', 'investigatorAffiliation': 'George Washington University'}}}}