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Trial · Interventional

CompletedPhase 4Registry data

Effect of GLP-1 on Angiogenesis

Short name ANGIOSAFE 1

NCTNCT02686177 (opens ClinicalTrials.gov in a new tab)Other idP140710Other id2015-002930-35Other id2015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
50 participants (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Design
Randomized · Open label (no masking)
Countries
1 country

France

Start
18 May 2016
Primary completion
8 Aug 2017
Completion
28 May 2021
First posted
19 Feb 2016 (estimated)
Last update posted
15 Jun 2021
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019202020212022
  1. Ph 4

    ANGIOSAFE 1

    NCT02686177

    18 May 2016 to 28 May 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis. The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.

Interventions

  • LiraglutideDrug
  • Metformin or sulfonylureaDrug

Arms2

  • Experimental

    1: Liraglutide

    Liraglutide 1,2 mg once daily subcutaneous injection for 1 month (4 weeks)

  • Active comparator

    2: Add on oral antidiabetic medication

    Metformin or sulfonylurea depending on monotherapy

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Difference of ANGPTL4 concentration at 4 weeks of treatment from baseline in Liraglutide and control group

    Time frame · At 1 month

Secondary outcomes(4)

  1. Difference of ANGPT2 concentration at 4 weeks of treatment from baseline in Liraglutide and control group

    Time frame · 4 weeks

    Registry description

    We will use commercial ANGPT2 commercial ELISA assays

  2. Difference of endothelial circulating progenitor cells (CD34+KDR+) concentration at 4 weeks of treatment from baseline in Liraglutide and control group

    Time frame · 4 weeks

    Registry description

    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

  3. Difference of AngiomiR-126 expression at 4 weeks of treatment from baseline in Liraglutide and control group

    Time frame · 4 weeks

    Registry description

    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. 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)

    Time frame · 4 weeks

    Registry description

    The measurement of circulating soluble adhesion molecules as endothelial activation markers: ICAM-1 and VCAM-1 will be done with ELISA commercial assays

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

3 results

Glucagon-like Peptide 1 Receptor Agonists, Diabetic Retinopathy and Angiogenesis: The AngioSafe Type 2 Diabetes Study.

Gaborit et al. 2020The Journal of clinical endocrinology and metabolismcited by 69

PMID 31589290DOI 10.1210/clinem/dgz069PUB-31589290

Full text at the publisher3 results
Publisher pageSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 diabetic patients (ADA criteria) * Age \> 18 years * Obesity (BMI \>= 25 kg/m2) * HbA1c \> 6.5 % * Treatment with Metformin and/or secretagogues * Effective contraception (women) Exclusion Criteria: * Treatment with Exenatide, Liraglutide or other incretinergic regimen (\<1 month before recruitment) * Type 1 diabetes * acute disease or infection * chronic renal failure (MDRD eGFR≤50 mL/min) * recent cardiovascular event or surgery (\<3 months) * pancreatitis history * anti-VEGF treatment * untreated cancer * immunological disorders * pregnancy and lactation * Vulnerable people : deprivation of Liberty safeguards * hypersensitivity to the active substance or to any of the excipients of the investigational drug * diabetic ketoacidosis * heart failure stage 3 or 4 (NYHA III-IV) * Hepatic insufficiency * inflammatory bowel disease and gastroparesis * No affiliation to the social security

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