Type 2 Diabetes MellitusR2D2NCT01536808
Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?
A study testing Cardiac RMI, Analysis telomere and Stress test in people with Type 2 Diabetes Mellitus, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Cardiac RMI, Analysis telomere and Stress test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Cardiac RMI, Analysis telomere, Stress test, echocardiography
- Keywords
- Diabetes mellitus, accelerated aging, cellular senescence, diabetic cardiomyopathy, strain imaging, strain rate imaging,, echocardiography
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RMIOther
Cardiac RMI
Analysis telomereOther
Analysis telomere
Stress testOther
Stress test
echocardiographyOther
echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Mellitus | Experimental | Not described Receives: Other: Cardiac RMI; Other: Analysis telomere; Other: Stress test; Other: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (3)
Dysfunction by speckle tracking imaging
Study the incidence of subtle regional myocardial dysfunction by speckle tracking imaging (longitudinal and radial systolic strain)
Measured: 36 months
Determine the predictive value of alteration
Determine the predictive value of alteration : Proteinuria, glycosylated haemoglobin, diabetes mellitus duration, blood pressure, BNP dosage, MRI diagnoses
Measured: 36 months
Cardiovascular events
Investigate the predictive value of all those factors( telomere shortening, telomerase activity, echo abnormalities) on cardiovascular events including MI, HF, arrhythmia; ACV
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startApr 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geneviève Dérumeaux, MD, Principal investigator, Hospices Civils de Lyon - Hôpital Louis Pradel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536808
- Sponsor's protocol ID
- 2008.506
- Acronym
- R2D2
- Status last verified
- Sep 2025
- First submitted
- 16 Feb 2012
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sen I, Trzaskalski NA, Hsiao YT, Liu PP, Shimizu I, Derumeaux GA. Aging at the Crossroads of Organ Interactions: Implications for the Heart. Circ Res. 2025 May 23;136(11):1286-1305. doi: 10.1161/CIRCRESAHA.125.325637. Epub 2025 May 22.
PubMed 40403108
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?
- ClinicalTrials.gov ID
- NCT01536808
- Acronym / sponsor ID
- R2D2 / 2008.506
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes mellitus, accelerated aging, cellular senescence, diabetic cardiomyopathy, strain imaging, strain rate imaging,, echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus | Experimental | Other: Cardiac RMI, Other: Analysis telomere, Other: Stress test, Other: echocardiography |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Type 2 Diabetes mellitus
- 40 < Age < 55 years old
- oral antidiabetic or insulin treatment
- No symptoms
- Sinus rhythm
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac RMICardiac RMI | Other | Type 2 Diabetes Mellitus |
| Analysis telomereAnalysis telomere | Other | Type 2 Diabetes Mellitus |
| Stress testStress test | Other | Type 2 Diabetes Mellitus |
| echocardiographyechocardiography | Other | Type 2 Diabetes Mellitus |
Primary outcome
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.
3 secondary outcomes
Dysfunction by speckle tracking imaging
Time frame: 36 months
Determine the predictive value of alteration
Time frame: 36 months
Cardiovascular events
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publication: PubMed 40403108Sen I, Trzaskalski NA, Hsiao YT, Liu PP, Shimizu I, Derumeaux GA. Aging at the Crossroads of Organ Interactions: Implications for the Heart. Circ Res. 2025 May 23;136(11):1286-1305. doi: 10.1161/CIRCRESAHA.125.325637. Epub 2025 May 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geneviève Dérumeaux, MD principal investigator
Hospices Civils de Lyon - Hôpital Louis Pradel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac RMI, Analysis telomere and Stress test in people with Type 2 Diabetes Mellitus, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere shortening (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01536808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.