NCT01295385

Brief Summary

Diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary microcirculation linked to an endothelial dysfunction. Abnormalities of the myocardial metabolism is frequently associated. It is regrettably about a hypothesis difficult to verify with current medical techniques.This deficiency being not only harmful to the diagnosis, but also to the assessment of the efficiency of the medical treatment on the myocardial metabolism and the endothelial function. Techniques of nuclear magnetic resonance offer interesting perspectives.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

4.3 years

First QC Date

January 26, 2011

Last Update Submit

April 20, 2015

Conditions

Keywords

type 2 diabetesCardiovascular diseasescoronary syndrome have abnormalities of glucidic metabolism

Outcome Measures

Primary Outcomes (1)

  • To quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers

    The myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique.

    12 months

Secondary Outcomes (1)

  • To estimate the metabolic and structural abnormalities in this population

    12 months

Study Arms (2)

healthy volunteers

EXPERIMENTAL
Other: NUCLEAR MAGNETIC RESONANCE IMAGING

patients with a diabetic cardiomyopathy

ACTIVE COMPARATOR
Other: NUCLEAR MAGNETIC RESONANCE IMAGING

Interventions

Techniques of nuclear magnetic resonance offer interesting perspectives in this context, and particularly to quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers.

healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 18 years old
  • patient type 2 diabetes affects taken care more than 5 years to Timone Hospital
  • patient with a diabetic cardiomyopathy
  • informed and consented

You may not qualify if:

  • less than 18 years
  • Pregnant woman
  • patient type 1 diabetes affects
  • patient presents a cardiomyopathy mixed (no diabetic)
  • patients presents an arrhythmia ventriculaire or above - ventriculaire
  • Unstable hémodynamique patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hopitaux de Marseille

Marseille, 13, France

RECRUITING

MeSH Terms

Conditions

CardiomyopathiesDiabetes Mellitus, Type 2Cardiovascular Diseases

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jacques Quilici, Doctor

    APHM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques Quilici, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

February 14, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations