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

Civil Hospices of Lyon

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Analysis telomere; Other: Cardiac RMI; Other: Stress test; Other: echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT01536808

2008.506

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Type 2 Diabetes Mellitus

Experimental group

Treatment:

Other: echocardiography

Other: Stress test

Other: Analysis telomere

Other: Cardiac RMI