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

This study is currently recruiting participants.
Verified August 2010 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01536808
First received: February 16, 2012
Last updated: January 17, 2013
Last verified: August 2010
History of Changes
  Purpose

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.

Condition Intervention
Type 2 Diabetes Mellitus
 Other: Cardiac RMI
Other: Analysis telomere
Other: Stress test
Other: echocardiography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Telomere shortening [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Dysfunction by speckle tracking imaging [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Study the incidence of subtle regional myocardial dysfunction by speckle tracking imaging (longitudinal and radial systolic strain)

  • Determine the predictive value of alteration [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Determine the predictive value of alteration : Proteinuria, glycosylated haemoglobin, diabetes mellitus duration, blood pressure, BNP dosage, MRI diagnoses

  • Cardiovascular events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Investigate the predictive value of all those factors( telomere shortening, telomerase activity, echo abnormalities) on cardiovascular events including MI, HF, arrhythmia; ACV


Estimated Enrollment: 150
Study Start Date: April 2009
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Cardiac RMI
    Cardiac RMI
    Other: Analysis telomere
    Analysis telomere
    Other: Stress test
    Stress test
    Other: echocardiography
    echocardiography
  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536808

Contacts
Contact: Geneviève Derumeaux, Pr +33472119087 genevieve.derumeaux@chu-lyon.fr

Locations
France
Laboratoire d'échocardiographie Recruiting
Bron, France, 69500
Contact: Geneviève Dérumeaux, Pr     4 72 11 90 87        
Principal Investigator: Geneviève Dérumeaux, Pr            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Geneviève Dérumeaux, Pr Hospices Civils de Lyon - Hôpital Louis Pradel
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01536808     History of Changes
Other Study ID Numbers: 2008.506
Study First Received: February 16, 2012
Last Updated: January 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Diabetes mellitus
accelerated aging
cellular senescence
diabetic cardiomyopathy
 strain imaging
strain rate imaging,
echocardiography

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Aging, Premature
Cardiomyopathies
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013