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

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ClinicalTrials.gov Identifier: NCT01536808
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Cardiac RMI Other: Analysis telomere Other: Stress test Other: echocardiography Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?
Study Start Date : April 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536808


Locations
France
Laboratoire d'échocardiographie
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Geneviève Dérumeaux, MD Hospices Civils de Lyon - Hôpital Louis Pradel

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01536808     History of Changes
Other Study ID Numbers: 2008.506
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

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
Cardiomyopathies
Aging, Premature
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms