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Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy? (R2D2)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac RMI
Analysis telomere
Stress test
echocardiography
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Diabetes mellitus, accelerated aging, cellular senescence, diabetic cardiomyopathy, strain imaging, strain rate imaging,, echocardiography

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Laboratoire d'échocardiographie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Type 2 Diabetes Mellitus

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dysfunction by speckle tracking imaging
Study the incidence of subtle regional myocardial dysfunction by speckle tracking imaging (longitudinal and radial systolic strain)
Determine the predictive value of alteration
Determine the predictive value of alteration : Proteinuria, glycosylated haemoglobin, diabetes mellitus duration, blood pressure, BNP dosage, MRI diagnoses
Cardiovascular events
Investigate the predictive value of all those factors( telomere shortening, telomerase activity, echo abnormalities) on cardiovascular events including MI, HF, arrhythmia; ACV

Full Information

First Posted
February 16, 2012
Last Updated
August 2, 2017
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01536808
Brief Title
Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?
Acronym
R2D2
Official Title
Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes mellitus, accelerated aging, cellular senescence, diabetic cardiomyopathy, strain imaging, strain rate imaging,, echocardiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type 2 Diabetes Mellitus
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cardiac RMI
Intervention Description
Cardiac RMI
Intervention Type
Other
Intervention Name(s)
Analysis telomere
Intervention Description
Analysis telomere
Intervention Type
Other
Intervention Name(s)
Stress test
Intervention Description
Stress test
Intervention Type
Other
Intervention Name(s)
echocardiography
Intervention Description
echocardiography
Primary Outcome Measure Information:
Title
Telomere shortening
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Dysfunction by speckle tracking imaging
Description
Study the incidence of subtle regional myocardial dysfunction by speckle tracking imaging (longitudinal and radial systolic strain)
Time Frame
36 months
Title
Determine the predictive value of alteration
Description
Determine the predictive value of alteration : Proteinuria, glycosylated haemoglobin, diabetes mellitus duration, blood pressure, BNP dosage, MRI diagnoses
Time Frame
36 months
Title
Cardiovascular events
Description
Investigate the predictive value of all those factors( telomere shortening, telomerase activity, echo abnormalities) on cardiovascular events including MI, HF, arrhythmia; ACV
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geneviève Dérumeaux, MD
Organizational Affiliation
Hospices Civils de Lyon - Hôpital Louis Pradel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoire d'échocardiographie
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

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

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