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Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?

Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01536808
Acronym
R2D2
Enrollment
150
Registered
2012-02-22
Start date
2009-04-30
Completion date
2014-12-31
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus, accelerated aging, cellular senescence, diabetic cardiomyopathy, strain imaging, strain rate imaging,, echocardiography

Brief summary

The potential clinical implications of this study are to optimise the selection of a population at risk for developing a diabetic cardiomyopathy among diabetic patients in order to develop early therapeutic strategies to prevent the left ventricular remodelling. Therefore, the originality of this project is to hypothesize that : * Diabetes mellitus is often associated with a premature aging syndrome * Cellular senescence may potentiate the mechanisms that are involved in decreasing myocardial contractility in DM and, * DM associated to premature aging may increase the risk of developing a cardiomyopathy Thus, the modulation of telomerase activity and the control of telomere length, together with the attenuation of the formation of reactive oxygen species, might represent important new targets in order to develop therapeutic tools in prevention of diabetic cardiomyopathy.

Interventions

OTHERCardiac RMI

Cardiac RMI

OTHERAnalysis telomere

Analysis telomere

Stress test

OTHERechocardiography

echocardiography

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Type 2 Diabetes mellitus * 40 \< Age \< 55 years old * oral antidiabetic or insulin treatment * No symptoms * Sinus rhythm * no sign or history of heart disease * LVEF \> 55% * Absence of regional left ventricular motion abnormalities.

Exclusion criteria

* absence of sinus rhythm, * silent ischemia defined as positive exercise test or positive stress echocardiography, * history of cardiomyopathy or CAD, * valvular heart disease hemodynamically significant, * severe renal insufficiency defined as creatinine clearance \< 30 mL/min, * echocardiographic images unsuitable for quantification, * type 1 diabetes mellitus, * Important diabetes mellitus imbalance defined as glycated hemoglobin \> 9% or glycemia \> 3g/L uncontrolled hypertension (\> 180/100 mmHg).

Design outcomes

Primary

MeasureTime frameDescription
Telomere shortening36 monthsInvestigate whether biomarkers for senescence determined from blood samples, including telomere shortening and telomerase activity in diabetic patients have an impact of left ventricular remodelling as compared with age-matched controls and biological aged control subjects.

Secondary

MeasureTime frameDescription
Dysfunction by speckle tracking imaging36 monthsStudy the incidence of subtle regional myocardial dysfunction by speckle tracking imaging (longitudinal and radial systolic strain)
Determine the predictive value of alteration36 monthsDetermine the predictive value of alteration : Proteinuria, glycosylated haemoglobin, diabetes mellitus duration, blood pressure, BNP dosage, MRI diagnoses
Cardiovascular events36 monthsInvestigate the predictive value of all those factors( telomere shortening, telomerase activity, echo abnormalities) on cardiovascular events including MI, HF, arrhythmia; ACV

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026