The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a) (EGLIPA)
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|ClinicalTrials.gov Identifier: NCT02501850|
Recruitment Status : Unknown
Verified July 2015 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was: Recruiting
First Posted : July 17, 2015
Last Update Posted : July 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 2||Drug: Liraglutide Drug: metformin||Phase 4|
Background: Lipoprotein (a) [Lp (a)] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp (a) in hepatocytes.
Hypothesis: Treatment with GLP-1R agonists will lower the levels of Lp (a) in patients with DM-2.
Objective: The objective of the study is to confirm in humans the results observed in vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.
Methods: we will evaluate 40 patients with DM-2 treated at the Endocrinology Department of the Vall d'Hebron University Hospital. The patients will be distributed in two groups according to the treatment prescribed by the endocrinologist during the visit of routine monitoring: group A (20 patients who were prescribred treatment with GLP-1R agonists) and group B (20 patients who were not prescribed this treatment). According to the current guidelines for treating DM-2, the GLP-1R agonists are situated as a second line treatment after metformin, and the treatment should be individualized according to the characteristics of each patient. (Inzucchi et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Diabetes Care 2012; 35 (6):.. 1364-1379). Following these recommendations, the GLP-1R agonists are usually selected when there is obesity and / or very important to avoid hypoglycaemia. The decision to prescribe a GLP-1R agonist is made by the endocrinologist before and independently of the patient´s participation in the study.
Blood levels of Lp(a) will be evaluated at baseline and at 2 months (+/- 15 days). Diabetic patients who are treated with insulin, enzyme inhibitors DPP-4 (IDDP-4) or already treated with receptor agonists GLP-1, presenting with kidney and liver failure, HbA1c> 10%, LDL-cholesterol> 180 mg / dl and / or triglycerides> 350 mg / dl will excluded.
Relevance: The results will identify a potential treatment for lowering levels of Lp (a) in patients with DM-2 and thus reducing cardiovascular risk associated with this lipoprotein.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||October 2015|
Experimental: Group A
Type 2 diabetic patients whom were prescribed GLP-1R agonists by the endocrinologist, according to usual clinical practice (liraglutide, exenatide, lixisenatide). The intervention is the prescription of an GLP-1R agonist (liraglutide, exenatide, lixisenatide)
Treatment with liraglutide, exenatide or lixisenatide
Active Comparator: Group B
Type 2 diabetic patients whom were prescribed metformin and/or sulphonilurea, according to usual clinical practice.
Treatment with metformin and/or sulphonilurea
Other Name: sulphonilurea
- Change in blood levels of Lipoprotein (a) (Lp(a)) [ Time Frame: Baseline and two months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501850
|Contact: Cristina Hernandez, MD, PhD||+34 934894172 ext firstname.lastname@example.org|
|Contact: Andreea Ciudin, PhD||+34 932744736 ext email@example.com|
|Hospital Universitari Vall d'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Andreea Ciudin, PhD +34932744736 firstname.lastname@example.org|
|Contact: Cristina Hernandez, MD, PhD +34 932746591 email@example.com|
|Principal Investigator: Cristina Hernandez, MD, PhD|
|Sub-Investigator: Andreea Ciudin, MD|
|Sub-Investigator: Olga Simó-Servat, MD|