NCT01536808

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

5.7 years

First QC Date

February 16, 2012

Last Update Submit

September 1, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitusaccelerated agingcellular senescencediabetic cardiomyopathystrain imagingstrain rate imaging,echocardiography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Dysfunction by speckle tracking imaging

    36 months

  • Determine the predictive value of alteration

    36 months

  • Cardiovascular events

    36 months

Study Arms (1)

Type 2 Diabetes Mellitus

EXPERIMENTAL
Other: Cardiac RMIOther: Analysis telomereOther: Stress testOther: echocardiography

Interventions

Cardiac RMIOTHER

Cardiac RMI

Type 2 Diabetes Mellitus
Analysis telomereOTHER

Analysis telomere

Type 2 Diabetes Mellitus
Stress testOTHER

Stress test

Type 2 Diabetes Mellitus
echocardiographyOTHER

echocardiography

Type 2 Diabetes Mellitus

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 2 Diabetes mellitus
  • \< 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire d'échocardiographie

Bron, 69500, France

Location

Related Publications (1)

  • 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.

    PMID: 40403108BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusDiabetic Cardiomyopathies

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiomyopathiesHeart DiseasesCardiovascular DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Geneviève Dérumeaux, MD

    Hospices Civils de Lyon - Hôpital Louis Pradel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

April 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 3, 2025

Record last verified: 2025-09

Locations

FR(1)