ovel diagnostic test to improve cardiovascular disease risk reduction in subjects with type 2 diabetes, increasing cost effectiveness and quality of life.
- Conditions
- Diabetestype 2 diabetes mellitus1008220610012653
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1500
In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- T2D patients with a glycated haemoglobin HbA1c level of >58 mmol/mole (or >7,5%).
T2D definition: T2D is the most common type of diabetes. In this condition, plasma glucose levels cannot be kept within the normal range. T2D is being developed due to a gradual decrease of insulin production by beta cells in the pancreas and/or due to a decrease of insulin sensitivity (insulin resistance). Causing a reduction in glucose uptake from the bloodstream. That can lead to continuously high glucose levels (hypertriglyceridemia). The diagnosis of T2D can be made according to fasting glucose levels >7.0 mmol/L. The golden standard is the Oral Glucose Tolerance Test (OGTT) where the glucose levels are being measured 2 hours after the ingestion of a glucose-load and have to be >11.1 mmol/L to makeobtain the diagnosis.;- Age > 18 years
A potential subject who meets any of the following criteria will be excluded from participation in this study:;- (potential) pregnancy (pregnancy / wishing to get pregnant / might be pregnant due for example loss of good anticonception).
In all these cases the women will be excluded from the study. The reason therefore is that the effect of cholesterol lowering treatment on the unborn infant has not been tested before, and therefore can potentially be harmful to the unborn infant. Women in the productive age will be asked about the possibility of pregnancy and the anticonception used, before they can be included in this study. (This procedure does not differ from usual care).
- Incapacitated subjects.
- Patients who allready partcipated in an another ongoing intervention study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the number of cardiovascular events in T2D patients<br /><br>being treated with lipid lowering therapy based on the information of the<br /><br>conventional method in combination with the LP compared to the number of<br /><br>cardiovascular events in T2D patients treated with lipid lowering therapy based<br /><br>on the information of the conventional method exclusively. We will determine<br /><br>the percentage of patients that are being reclassified to a different risk<br /><br>group according to the addition of the LP to the conventional method (see<br /><br>protocol, scheme in §2. Objectives). We will also look at all-cause mortality<br /><br>in both the control and the intervention group. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Quality of life and cardiovascular disease will be assessed every 3 months (in<br /><br>combination with regular visits to the diabetic nurse). The questionnaires used<br /><br>are: the Rose questionnaire, EQ5D level 5 and we will add personal questions<br /><br>(about work, ethnicity, additional costs made because of the disease). At the<br /><br>end of the study we will make a cost-effectiveness analysis according to:- The<br /><br>extra costs of the LP as a diagnostic test- The reduction in costs because of<br /><br>reduced morbidity (for example: hospitalization)- Non-medical costs (for<br /><br>example productivity loss).</p><br>