Diabetes-related ComplicationsNCT02505451
Myocardial Regional Function by Dobutamine Stress Echocardiography in the Metabolic Syndrome and Type 2 Diabetes
A study testing dobutamine in people with Diabetes-related Complications, run by University of Avignon at 1 site in France.
Trial summary
Summary. Theoretical Rationale: The left ventricular myocardial performance results from a complex interplay between linear deformations (longitudinal, circumferential and radial) and twist/ untwist mechanics. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes-related Complications
- What is being tested?
- dobutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Jan 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female 40-65 years old, asymptomatic and free of coronary disease
Who cannot join
- for all the subjects :
- body mass index > 35 kg / m2, defining severe obesity,
- Under insulin therapy,
- Poorly controlled hypertension (> 140/95)
- Peripheral vascular disease (> stage II of Leriche)
- Heart disease or known coronary artery disease,
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- Known and poorly compensated thyroid dysfunction,
- Nocturnal apnea syndrome,
- Inability to give written informed consent,
- Chronic diseases,
- moderate to severe left ventricular hypertrophy :> 109 g / m2 in women and> 132 g / m2 in men and parietal thickness > 13mm.
- for the diabetic patients only :
- poor glycemic control (HbA1c > 9%)
- severe autonomic or peripheral neuropathy,
- Severe diabetic retinopathy,
- Advanced Diabetic nephropathy (defined by documented proteinuria and / or renal failure).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Analysis of Regional Myocardial Function in Response to Dobutamine Stress in Metabolic Syndrome and Type 2 Diabetic Patients. Effect of Cardiac Adiposity, Inflammation and Hyperglycaemia
Summary.
Theoretical Rationale:
Read more
The left ventricular myocardial performance results from a complex interplay between linear deformations (longitudinal, circumferential and radial) and twist/ untwist mechanics. These components of myocardial mechanics can be assessed, at rest and during stress conditions, by high resolution echocardiography using the "2D-strain" technology and constitute good indexes of tissue intrinsic contractility / relaxation properties. Type 2 diabetes (T2DM) and metabolic syndrome (MS) are associated with an increased risk for cardiac diseases. While several clinical studies have reported, particularly in T2DM, a diastolic dysfunction (concept of "diabetic cardiomyopathy"), the existence of impaired regional myocardial function, with altered intrinsic contractility properties, remains largely unanswered, especially in the SM. Stress echocardiography is very interesting to reveal myocardial dysfunction, discrete or absent at rest. To the best of our knowledge, no scientific study is, however, today available on the kinetics of linear strains and twist/untwist dynamics in response to stress in T2DM as well as SM. The epicardial adipose tissue is the source of production of important pro-inflammatory cytokines that have the potential, through an exacerbation of oxidative stress, to impair coronary endothelial function, increase fibrosis, but also directly affect cardiomyocyte calcium homeostasis. An increase in epicardial adipose tissue is consensually reported in T2DM and SM and is clearly associated with coronary atherosclerosis. A link between cardiac adiposity and overall cardiac function, particularly diastolic, is now suggested but to our knowledge no study has challenged its association with myocardial dysfunction in T2DM as SM patients.
Objectives and Methodology: - To investigate regional myocardial linear deformations and torsion, at rest and in response to a dobutamine stress, in asymptomatic T2DM and SM patients without clinical complications, - to study the links between expected regional myocardial abnormalities and inflammation, hyperglycemia and cardiac adiposity. A control group of healthy individuals matched for sex and age will also be included.
All the subjects will benefit from a clinical, anthropometric and biological evaluation. In addition, conventional echocardiography (remodelling and global diastolic and systolic functions) complemented by a functional analysis by tissue Doppler imaging will be performed. Furthermore, 2D cine loops will be recorded in the apical 4, 3 and 2- chamber views for the objective assessment of myocardial longitudinal deformations as well as in the parasternal short axis (base and apex) for the evaluation of the circumferential deformations and basal and apical rotations and left ventricular torsion, at rest and under low dose of dobutamine (110 and 120 bpm).
- Conditions
- Diabetes-related Complications
- Being tested
- dobutamine
- Keywords
- Metabolic syndrome, diabetes, myocardial function, dobutamine
- Medical subject headings
- Diabetes Complications, Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dobutamineDrug
In each participant, dobutamine will be administered via intravenous infusion in doses of 10, 20, 30 and 40 lg/kg/min during 3-min stages and 2D strain echocardiography will be performed at each stage.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic patients | Experimental | Regional myocardial function will be assessed during dobutamine stress echocardiography in asymptomatic patients with type II diabetes (according to the American Diabetes Association, 2012) free of coronary diseases. Receives: Drug: dobutamine |
| Metabolic syndrom | Experimental | Regional myocardial function will be assessed during dobutamine stress echocardiography in asymptomatic patients with the Metabolic syndrome (according to Alberti et al 2009) free of diabetes and coronary diseases. Receives: Drug: dobutamine |
| controls | Experimental | Regional myocardial function will be assessed during dobutamine stress echocardiography in healthy subjects. Receives: Drug: dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional longitudinal strain
Regional myocardial function will be evaluated for each participant at rest and during low dose dobutamine within a single session.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes-related ComplicationsStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Avignon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Obert, PhD, Study director, Laboratory of Cardiovascular Pharm-Ecology, Faculty of Health and Sciences, university of Avignon, 33 rue louis pasteur 84000 Avignon, France.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505451
- Sponsor's protocol ID
- UAPV-022015-SFC
- Status last verified
- Jan 2019
- First submitted
- 3 Jul 2015
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Analysis of Regional Myocardial Function in Response to Dobutamine Stress in Metabolic Syndrome and Type 2 Diabetic Patients. Effect of Cardiac Adiposity, Inflammation and Hyperglycaemia
- ClinicalTrials.gov ID
- NCT02505451
- Acronym / sponsor ID
- UAPV-022015-SFC
- Conditions
- Diabetes-related Complications
- Keywords
- Metabolic syndrome, diabetes, myocardial function, dobutamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of AvignonUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 22 Jul 2015 (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.
Summary.
Theoretical Rationale:
The left ventricular myocardial performance results from a complex interplay between linear deformations (longitudinal, circumferential and radial) and twist/ untwist mechanics. These components of myocardial mechanics can be assessed, at rest and during stress conditions, by high resolution echocardiography using the "2D-strain" technology and constitute good indexes of tissue intrinsic contractility / relaxation properties. Type 2 diabetes (T2DM) and metabolic syndrome (MS) are associated with an increased risk for cardiac diseases. While several clinical studies have reported, particularly in T2DM, a diastolic dysfunction (concept of "diabetic cardiomyopathy"), the existence of impaired regional myocardial function, with altered intrinsic contractility properties, remains largely unanswered, especially in the SM. Stress echocardiography is very interesting to reveal myocardial dysfunction, discrete or absent at rest. To the best of our knowledge, no scientific study is, however, today available on the kinetics of linear strains and twist/untwist dynamics in response to stress in T2DM as well as SM. The epicardial adipose tissue is the source of production of important pro-inflammatory cytokines that have the potential, through an exacerbation of oxidative stress, to impair coronary endothelial function, increase fibrosis, but also directly affect cardiomyocyte calcium homeostasis. An increase in epicardial adipose tissue is consensually reported in T2DM and SM and is clearly associated with coronary atherosclerosis. A link between cardiac adiposity and overall cardiac function, particularly diastolic, is now suggested but to our knowledge no study has challenged its association with myocardial dysfunction in T2DM as SM patients.
Objectives and Methodology: - To investigate regional myocardial linear deformations and torsion, at rest and in response to a dobutamine stress, in asymptomatic T2DM and SM patients without clinical complications, - to study the links between expected regional myocardial abnormalities and inflammation, hyperglycemia and cardiac adiposity. A control group of healthy individuals matched for sex and age will also be included.
All the subjects will benefit from a clinical, anthropometric and biological evaluation. In addition, conventional echocardiography (remodelling and global diastolic and systolic functions) complemented by a functional analysis by tissue Doppler imaging will be performed. Furthermore, 2D cine loops will be recorded in the apical 4, 3 and 2- chamber views for the objective assessment of myocardial longitudinal deformations as well as in the parasternal short axis (base and apex) for the evaluation of the circumferential deformations and basal and apical rotations and left ventricular torsion, at rest and under low dose of dobutamine (110 and 120 bpm).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patients | Experimental | Drug: dobutamineRegional myocardial function will be assessed during dobutamine stress echocardiography in asymptomatic patients with type II diabetes (according to the American Diabetes Association, 2012) free of coronary diseases. |
| Metabolic syndrom | Experimental | Drug: dobutamineRegional myocardial function will be assessed during dobutamine stress echocardiography in asymptomatic patients with the Metabolic syndrome (according to Alberti et al 2009) free of diabetes and coronary diseases. |
| controls | Experimental | Drug: dobutamineRegional myocardial function will be assessed during dobutamine stress echocardiography in healthy subjects. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female 40-65 years old, asymptomatic and free of coronary disease
Key exclusion criteria (16 listed)
- for all the subjects :
- body mass index > 35 kg / m2, defining severe obesity,
- Under insulin therapy,
- Poorly controlled hypertension (> 140/95)
- Peripheral vascular disease (> stage II of Leriche)
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 |
|---|---|---|
| dobutamineIn each participant, dobutamine will be administered via intravenous infusion in doses of 10, 20, 30 and 40 lg/kg/min during 3-min stages and 2D strain echocardiography will be performed at each stage. | Drug | Metabolic syndrom, Type 2 diabetic patients, controls |
Primary outcome
Regional longitudinal strain
Time frame: day 1
Regional myocardial function will be evaluated for each participant at rest and during low dose dobutamine within a single session.
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 18 Jan 2019.
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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.
Philippe Obert, PhD study director
Laboratory of Cardiovascular Pharm-Ecology, Faculty of Health and Sciences, university of Avignon, 33 rue louis pasteur 84000 Avignon, France.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dobutamine in people with Diabetes-related Complications, run by University of Avignon 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 1 inclusion and 16 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 18 Jan 2019. 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?
Regional longitudinal strain (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2019.