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CompletedNCT01536808R2D2Updated Sep 3, 2025

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

An interventional study of Cardiac RMI and Analysis telomere in Type 2 Diabetes Mellitus, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
40 Years to 55 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Diabetes mellitus
  • accelerated aging
  • cellular senescence
  • diabetic cardiomyopathy
  • strain imaging
  • strain rate imaging,
  • echocardiography
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 150 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Type 2 Diabetes Mellitus

    Other: Cardiac RMI · Other: Analysis telomere · Other: Stress test · Other: echocardiography

Interventions

  • OtherCardiac RMI

    Cardiac RMI

  • OtherAnalysis telomere

    Analysis telomere

  • OtherStress test

    Stress test

  • Otherechocardiography

    echocardiography

06

What researchers measure

Primary outcomes

  1. Telomere shortening

    Investigate 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.

    Time frame: 36 months

Secondary outcomes

  1. Dysfunction by speckle tracking imaging

    Study the incidence of subtle regional myocardial dysfunction by speckle tracking imaging (longitudinal and radial systolic strain)

    Time frame: 36 months

  2. Determine the predictive value of alteration

    Determine the predictive value of alteration : Proteinuria, glycosylated haemoglobin, diabetes mellitus duration, blood pressure, BNP dosage, MRI diagnoses

    Time frame: 36 months

  3. Cardiovascular events

    Investigate the predictive value of all those factors( telomere shortening, telomerase activity, echo abnormalities) on cardiovascular events including MI, HF, arrhythmia; ACV

    Time frame: 36 months

07

Study locations

1 site
  • Laboratoire d'échocardiographie
    Bron, 69500, France
08

References and documents

Publications

  • Sen I, Trzaskalski NA, Hsiao YT, Liu PP, Shimizu I, Derumeaux GA. Aging at the Crossroads of Organ Interactions: Implications for the Heart. Circ Res. 2025 May 23;136(11):1286-1305. doi: 10.1161/CIRCRESAHA.125.325637. Epub 2025 May 22. PubMed 40403108 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01536808
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Feb 22, 2012
Start date
Apr 2009
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Sep 3, 2025

Study contacts

Geneviève Dérumeaux, MD
principal investigator · Hospices Civils de Lyon - Hôpital Louis Pradel

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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