|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02505451 |
|
Date of registration:
|
03/07/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Myocardial Regional Function by Dobutamine Stress Echocardiography in the Metabolic Syndrome and Type 2 Diabetes
|
|
Scientific 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 |
|
Date of first enrolment:
|
July 2015 |
|
Target sample size:
|
125 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02505451 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Philippe Obert, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Laboratory of Cardiovascular Pharm-Ecology, Faculty of Health and Sciences, university of Avignon, 33 rue louis pasteur 84000 Avignon, France. |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Male and female 40-65 years old, asymptomatic and free of coronary disease
Exclusion Criteria:
- 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,
- 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).
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes-related Complications
|
|
Intervention(s)
|
|
Drug: dobutamine
|
|
Primary Outcome(s)
|
|
Regional longitudinal strain
[Time Frame: day 1]
|
|
Secondary ID(s)
|
|
UAPV-022015-SFC
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|