Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy? (R2D2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01536808|
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : August 3, 2017
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)|
|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|
|Experimental: Type 2 Diabetes Mellitus||
Other: Cardiac RMI
Other: Analysis telomere
Other: Stress test
- 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.
- 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)
- 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
- 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
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
|Bron, France, 69500|
|Principal Investigator:||Geneviève Dérumeaux, MD||Hospices Civils de Lyon - Hôpital Louis Pradel|