Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy? (R2D2)

September 1, 2025 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Laboratoire d'échocardiographie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Type 2 Diabetes Mellitus
Other: Cardiac RMI
Cardiac RMI
Other: Analysis telomere
Analysis telomere
Other: Stress test
Stress test
Other: echocardiography
echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
36 months
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
36 months
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
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Geneviève Dérumeaux, MD, Hospices Civils de Lyon - Hôpital Louis Pradel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimated)

February 22, 2012

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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