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The Impact of Glucose Lowering Therapies on Circulating Endothelial Progenitor Cells and Its Mobilising Factor Stromal Derived Factor-1α in Patients With Type 2 Diabetes (IGLOOS)

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ClinicalTrials.gov Identifier: NCT02694575
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester

Brief Summary:
This is a cross-sectional observational study aiming to examine and compare the impact of incretin based therapies i.e. dipeptidyl peptidase-4 (DPP4) inhibitors and glucagon-like peptide-1 (GLP-1) analogues, on endothelial progenitor cells (EPCs) and its mobilising factor, stromal derived factor-1 α (SDF-1 α), in patients with type 2 diabetes mellitus (T2DM) who are well established on those treatments. EPCs provide vascular protection by means of endothelial repair and neogenesis. This endothelial protective effect may potentially benefit patients affected by micro or macrovascular complications arising from vascular injury e.g. cardiovascular disease in T2DM. The study is of particular interest as a small study has shown an increase in level of circulating EPC in patients treated with DPP-4 inhibitors, thought to be mediated via the up regulation of its mobilising factor SDF-1 α.

Condition or disease
Diabetes Mellitus, Type 2 Cardiovascular Diseases

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Impact of Glucose Lowering Therapies Including Dipeptidyl Peptidase-4 Inhibitor on Circulating Endothelial Progenitor Cells (EPCs) and Its Mobilising Factor Stromal Derived Factor-1α (SDF-1α) in Patients With Type 2 Diabetes
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Other
Other - currently on other treatment (i.e., non-incretin based therapies)
GLP-1
Currently on GLP-1 analogue therapy
DPP-4
Currently on DPP-4 inhibitor therapy



Primary Outcome Measures :
  1. EPC [ Time Frame: Single sample analysis - no time frame ]
    The measure of number of circulating Endothelial Progenitor Cells (EPCs) (EPC/μl)


Secondary Outcome Measures :
  1. SDF 1-α (Stromal derived factor-1α) [ Time Frame: Single sample analysis - no time frame ]
    Level of SDF 1-α (Stromal derived factor-1α) biomarker analysis

  2. Glucagon-like peptide 1 (GLP-1) [ Time Frame: Single sample analysis - no time frame ]
    Level of GLP 1 (Glucagon like peptide 1) biomarker analysis.

  3. Dipeptidyl peptidase 4 (DDP-4) [ Time Frame: Single sample analysis - no time frame ]
    Level of DPP 4 (Dipeptidyl peptidase 4) biomarker analysis.

  4. C-reactive protein [ Time Frame: Single sample analysis - no time frame ]
    Level of C-reactive protein biomarker analysis.

  5. Nitric oxide (NO) [ Time Frame: Single sample analysis - no time frame ]
    Level of NO (Nitric oxide) biomarker analysis.

  6. Hypoxia-inducible factor -1α (HIF-1α) [ Time Frame: Single sample analysis - no time frame ]
    Level of HIF -1α (Hypoxia inducible factor -1α) biomarker analysis.

  7. Vascular endothelial growth factor (VEGF) [ Time Frame: Single sample analysis - no time frame ]
    Level of VEGF (Vascular endothelial growth factor) biomarker analysis.

  8. Granulocyte colony stimulating factor (G-CSF) [ Time Frame: Single sample analysis - no time frame ]
    Level of G-CSF (Granulocyte colony stimulating factor) biomarker analysis.

  9. Stem cell factor (SCF) [ Time Frame: Single sample analysis - no time frame ]
    Level of SCF (Stem cell factor) biomarker analysis.

  10. High Mobility Group Box-1 (HMGB-1) [ Time Frame: Single sample analysis - no time frame ]
    Level of HMGB-1 (high mobility group box-1) biomarker analysis.

  11. Full blood count [ Time Frame: Single sample analysis - no time frame ]
    Full blood count analysis

  12. HbA1c [ Time Frame: Single sample analysis - no time frame ]
    HbA1c analysis

  13. Renal function [ Time Frame: Single sample analysis - no time frame ]
    Renal function analysis


Biospecimen Retention:   Samples Without DNA

Peripheral Blood Mononuclear Cells (PBMCs) for subsequent EPC quantification:

PBMCs will be isolated from venous blood collected into a 9.7ml sodium heparin blood tube. EPCs will be quantified as cells showing dual positivity for the cell surface / transmembrane markers: CD24 and KDR (Kinase Insert Domain Receptor). SDF-1α analysis and the analysis of biomarkers associated with the prevalence of circulating EPCs will be measured using sandwich ELISA and multi-array ELISA technology in-line with manufacturer protocols. Analysis of endogenous DPP4 will be assayed using a commercial colorimetric assay; again manufacturer protocols will be followed. Biomarker and DPP4 analysis will be carried out in one batch on stored sodium heparin plasma samples.



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients aged between 35 and 70 years of age (inclusve) who have established Type 2 Diabetes mellitus (T2DM) and who have been receiving either (a) DPP-4 inhibitors, (b) GLP-1 analogues, or (c) non-incretin based treatments for at least 3 months (or more).
Criteria

Inclusion Criteria:

  • Capacity to provide informed consent before any study-related activities
  • Individuals aged 35-70 years inclusive
  • Both male and female
  • Diagnosed with T2DM for at least 1 year
  • On DPP4-inhibitor, GLP-1 analogue or non-incretin agent for at least 3 months regardless of their background treatment
  • White European or South Asian ethnicity (to increase the comparability of treatment groups)

Exclusion Criteria:

  • Type 1 diabetes
  • Individuals <35 or >70 years of age
  • Prescribed thiazolidinediones or sodium-glucose co-transporter-2 (SGLT-2) inhibitors within the last 3 months
  • Any form of terminal illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694575


Locations
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United Kingdom
Leicester Diabetes Centre
Leicester, Leicestershire, United Kingdom, LE5 4PW
Sponsors and Collaborators
University of Leicester
University Hospitals, Leicester
Investigators
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Principal Investigator: Melanie J Davies, MBBS MD University of Leicester

Publications:
IDF. IDF diabetes atlas 5th Edition. 2011.
DUK. Diabetes in the UK 2010 Key Satistics on Daibetes. 2010: 1-21.

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT02694575     History of Changes
Other Study ID Numbers: UNOLE 0483
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Clinically significant blood result data will be shared with the participant's General Practitioner when appropriate.

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs