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

NCT ID: NCT01536808

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Type 2 Diabetes Mellitus

Group Type EXPERIMENTAL

Cardiac RMI

Intervention Type OTHER

Cardiac RMI

Analysis telomere

Intervention Type OTHER

Analysis telomere

Stress test

Intervention Type OTHER

Stress test

echocardiography

Intervention Type OTHER

echocardiography

Interventions

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Cardiac RMI

Cardiac RMI

Intervention Type OTHER

Analysis telomere

Analysis telomere

Intervention Type OTHER

Stress test

Stress test

Intervention Type OTHER

echocardiography

echocardiography

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geneviève Dérumeaux, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon - Hôpital Louis Pradel

Locations

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Laboratoire d'échocardiographie

Bron, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 40403108 (View on PubMed)

Other Identifiers

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2008.506

Identifier Type: -

Identifier Source: org_study_id

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