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

Type 2 Diabetes Mellitus Clinical Trial

— R2D2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536808
• Other study ID #: 2008.506
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: August 2, 2017
• Start date: April 2009
• Est. completion date: December 2014

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aging, Premature
• Cardiomyopathies
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Cardiac RMI
Cardiac RMI
• Analysis telomere
Analysis telomere
• Stress test
Stress test
• echocardiography
echocardiography

Locations

Country	Name	City	State
France	Laboratoire d'échocardiographie	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telomere shortening	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.	36 months
Secondary	Dysfunction by speckle tracking imaging	Study the incidence of subtle regional myocardial dysfunction by speckle tracking imaging (longitudinal and radial systolic strain)	36 months
Secondary	Determine the predictive value of alteration	Determine the predictive value of alteration : Proteinuria, glycosylated haemoglobin, diabetes mellitus duration, blood pressure, BNP dosage, MRI diagnoses	36 months
Secondary	Cardiovascular events	Investigate the predictive value of all those factors( telomere shortening, telomerase activity, echo abnormalities) on cardiovascular events including MI, HF, arrhythmia; ACV	36 months