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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Cardiac RMI; Other: Analysis telomere; Other: Stress test; Other: echocardiography

• Registration Number: NCT01536808
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes Mellitus	Cardiac RMI	-
Type 2 Diabetes Mellitus	Stress test	-
Type 2 Diabetes Mellitus	Analysis telomere	-
Type 2 Diabetes Mellitus	echocardiography	-

Primary Outcome Measures

Name	Time	Method
Telomere shortening	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

Name	Time	Method
Dysfunction by speckle tracking imaging	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	36 months	Determine the predictive value of alteration : Proteinuria, glycosylated haemoglobin, diabetes mellitus duration, blood pressure, BNP dosage, MRI diagnoses
Cardiovascular events	36 months	Investigate the predictive value of all those factors( telomere shortening, telomerase activity, echo abnormalities) on cardiovascular events including MI, HF, arrhythmia; ACV

Trial Locations

Locations (1)

Laboratoire d'échocardiographie; 🇫🇷 Bron, France