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OpenTrials
Completed

NCT Number: NCT01536808

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiomyopathies Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Cardiomyopathies Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratoire d'échocardiographie

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cardiac RMI

Other

Cardiac RMI

Analysis telomere

Other

Analysis telomere

stress test

Other

Stress test

echocardiography

Other

echocardiography

Primary outcomes

  1. Telomere shortening

    Time frame: 36 months

    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.

Secondary outcomes

  1. Dysfunction by speckle tracking imaging

    Time frame: 36 months

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

  2. Determine the predictive value of alteration

    Time frame: 36 months

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

  3. Cardiovascular events

    Time frame: 36 months

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: R2D2

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Feb 22, 2012
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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