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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05651919
Other study ID # 69HCL22_0580
Secondary ID 2022-A02435-38
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2023
Est. completion date February 23, 2025

Study information

Verified date May 2024
Source Hospices Civils de Lyon
Contact Hélène THIBAULT, PU,PH
Phone 0427856691
Email Helene.thibault@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Type 2 diabetes (T2D), especially when associated with metabolic syndrome (MS) is at high risk to develop heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF), and the specific impact of T2D+MS in cardiac function impairment is usually known as "diabetic cardiomyopathy" (DC). Cardiac remodelling (ie hypertrophy) and subtle myocardial dysfunction are highly prevalent in T2D+MS but not specific enough to predict further HFpEF or HFmrEF. Also, current biomarkers can identify but do not predict HFpEF or HFmrEF in T2D patients; Furthermore, specific biomarkers are needed. Peripheral blood mononuclear cells (PBMC) obtained from a peripheral blood sample can provide insights from calcic and inflammatory pathways, and may identify more specific molecular signatures shared between T2D+MS and HFpEF.


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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
France Hopital Louis Pradel Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of Initial level of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF The calcic profile of PBMC will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (initial level). Day of blood sample (inclusion visit)
Primary Comparison of amplitude of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF The calcic profile of PBMC will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (amplitude). Day of blood sample (inclusion visit)
Primary Comparison of area under curve of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF The calcic profile will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (area under curve). Day of blood sample (inclusion visit)
Primary Comparison of slope of the response to pharmacological stimulation of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF The calcic profile of PBMC will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (slope of the response to pharmacological stimulation). Day of blood sample (inclusion visit)
Primary Comparison of the inflammatory profile of PBMC from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF The inflammatory profile will evaluate by flow cytometry the proportion of the different populations of monocytes and lymphocytes using several labeling antibodies. Day of blood sample (inclusion visit)
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