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Clinical Trial Details

Trial ID: L7333
Source ID: NCT02686177
Associated Drug: Liraglutide
Title: Effect of GLP-1 on Angiogenesis
Acronym: ANGIOSAFE 1
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Liraglutide|DRUG: Metformin or sulfonylurea
Outcome Measures: Primary: Difference of ANGPTL4 concentration at 4 weeks of treatment from baseline in Liraglutide and control group, At 1 month | Secondary: Difference of ANGPT2 concentration at 4 weeks of treatment from baseline in Liraglutide and control group, We will use commercial ANGPT2 commercial ELISA assays, 4 weeks|Difference of endothelial circulating progenitor cells (CD34+KDR+) concentration at 4 weeks of treatment from baseline in Liraglutide and control group, Circulating progenitor cells (EPCs) will be quantified using flow cytometry before and after one month treatment GLP-1 receptor agonist or reference treatment (control group). Briefly, after erythrocyte lysis, peripheral blood will be stained with 10µL fluorescein isothiocyanate-conjugated anti-human CD34 mAb (Becton Dickinson), 10µL phycoethrin-conjugated anti-human KDR mAb (R\&D Systems), and 10µL allophycocyanin-conjugated anti-CD133 mAb (Miltenyi Biotech). The frequency of CD34+ cells, CD34+ KDR+ cells before and after GLP-1R agonist or control treatment will be determined by a two-dimensional side-scatter fluorescence dot plot analysis after appropriate gating using blood samples from above-stated recruited patients, 4 weeks|Difference of AngiomiR-126 expression at 4 weeks of treatment from baseline in Liraglutide and control group, AngiomiR-126 will be extracted from the fresh isolated cells using the miRNeasy Mini Kit (Qiagen) microRNA expression levels will be compared between type 2 diabetic subjects, before and after one-month GLP-1R agonist treatment and in the control group, 4 weeks|Difference of Circulating soluble adhesion molecules as endothelial activation markers: ICAM-1 and VCAM-1 concentration at 4 weeks of treatment from baseline (Liraglutide versus control group), The measurement of circulating soluble adhesion molecules as endothelial activation markers: ICAM-1 and VCAM-1 will be done with ELISA commercial assays, 4 weeks
Sponsor/Collaborators: Sponsor: Assistance Publique - Hôpitaux de Paris
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-05-18
Completion Date: 2021-05-28
Results First Posted:
Last Update Posted: 2021-06-15
Locations: Nutrition department, pole ENDO - Assistance Publique Hôpitaux Marseille, Marseille, 13005, France
URL: https://clinicaltrials.gov/show/NCT02686177