|- candidate number||8221|
|- NTR Number||NTR2426|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jul-2010|
|- Secondary IDs||P09.241 MEC LUMC|
|- Public Title||Het effect van een suikerbelasting op de vaatwand van de aorta.|
|- Scientific Title||Effects of postprandial hyperglycemia on aortic elasticity in impaired glucose tolerance and diabetes mellitus type 2.|
|- hypothesis||Postprandial hyperglycemia has a negative effect on aortic elasticity in patients with impaired fasting glucose versus matched controls.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Aortic elasticity|
|- Inclusion criteria||1. Impaired fasting glucose (fasting glucose 5.6-6.9 mmol/l);|
2. Age 18-75 years;
3. Informed consent.
1. Subjects with normal fasting glucose matched for age (18-75), BMI, blood pressure and gender;
2. Informed consent.
|- Exclusion criteria||1. Fasting plasma glucose =/. 7 mmol/l or previously diagnosed T2DM;|
2. Grade 2 or 3 hypertension at screening according to ESC guidelines 2007;
3. Use of medication; antihypertensives, glucose lowering medication, statins of fibrates;
4. Any significant chronic disease;
5. Renal, hepatic or other endocrine disease;
8. Contra-indications MRI;
9. Recent participation in other research projects in one year.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||12-mrt-2010|
|- planned closingdate||1-jan-2011|
|- Target number of participants||36|
|- Interventions||Subjects will arrive after an overnight fast. A cannula will be inserted for blood drawing during the MRI scan. MRI scan will be performed to measure baseline cardiac function, abdominal waist fat and pulse wave velocity. After this MRI scan heart rate variability will be measured by a 5 minurte ECG registration. Subsequently the patient will drink on one study day a 75g oral carbohydrate load (75g dextrose in 300 ml water) and on the other study day only 300 ml water as contol. At 30, 60, 90 and 120 minutes post-carbohydrate load, blood samples will be collected for insulin and glucose levels. Post-carbohydrate MRI evaluation of pulse wave velocity is performed at one or two hours after the carbohydrate load. Heart rate variability will me measured again immediately after the MRI scans. Optimal time of measurement will be defined in six patients.|
|- Primary outcome||1. Magnetic resonance imaging: Aortic pulse wave velocity;|
2. Heart rate variability.
|- Secondary outcome||1. Heart dimensions: End-diastolic volume, end systolic volume, LV mass, LV mass index, LVMI/EDVI;|
2. Heart function: Systolic function (stroke volume, ejection fraction, cardiac output, cardiac index, peak ejection rate), diastolic function (early peak filling rate E, early deceleration peak, atrial peak filling rate A, E/A ratio, peak mitral annulus longitudinal motion, MR estimate of LV filling pressure);
3. Body fat distribution;
4. Glucose and insulin levels.
|- Timepoints||2 study days separated by 7-day intervals.|
Each study day will consist of approximately 5 hours. For the study protocol the total examination time will be 80 minutes for the first MRI scan and 60 for the second MRI scan.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. N. Tjeerdema|
|- CONTACT for SCIENTIFIC QUERIES||Drs. N. Tjeerdema|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Center for Translational Molecular Medicine (CTMM)|
|- Brief summary||Study of the effects of postprandial hyperglycemia in patients with impaired fasting glucose versus matched controls on aortic elasticity measured by the pulse wave velocity and heart rate variability. |
|- Main changes (audit trail)|
|- RECORD||8-jul-2010 - 5-aug-2010|