Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy? (NCT01536808) | Clinical Trial Compass
CompletedNot Applicable
Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?
France150 participantsStarted 2009-04
Plain-language 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.
Who can participate
Age range
40 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.