- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01536808
Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy? (R2D2)
August 2, 2017 updated by: Hospices Civils de Lyon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bron, France, 69500
- Laboratoire d'échocardiographie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Type 2 Diabetes Mellitus
|
Cardiac RMI
Analysis telomere
Stress test
echocardiography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
36 months
|
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
|
36 months
|
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
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Geneviève Dérumeaux, MD, Hospices Civils de Lyon - Hopital Louis Pradel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
February 16, 2012
First Submitted That Met QC Criteria
February 21, 2012
First Posted (Estimate)
February 22, 2012
Study Record Updates
Last Update Posted (Actual)
August 3, 2017
Last Update Submitted That Met QC Criteria
August 2, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008.506
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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