ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a) (EGLIPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:
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. The objective of the study is to test 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Liraglutide Drug: metformin Phase 4

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Drug: Liraglutide
Treatment with liraglutide, exenatide or lixisenatide
Other Names:
  • Exenatide
  • Lixisenatide

Active Comparator: Group B
Type 2 diabetic patients whom were prescribed metformin and/or sulphonilurea, according to usual clinical practice.
Drug: metformin
Treatment with metformin and/or sulphonilurea
Other Name: sulphonilurea




Primary Outcome Measures :
  1. Change in blood levels of Lipoprotein (a) (Lp(a)) [ Time Frame: Baseline and two months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • age between 50-65 years
  • written informed consent

Exclusion Criteria:

  • active GLP-1R agonist, insulin or DPP-IV treatment.
  • Liver failure (3lsn AST and/or ALT)
  • Kidney failure (FG <30ml/min/1,73m2),
  • HbA1c> 10%
  • LDL-cholesterol> 180 mg/dl
  • Triglycerides> 350 mg/dl

Information from the National Library of Medicine

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


Contacts
Contact: Cristina Hernandez, MD, PhD +34 934894172 ext 4172 cristina.hernandez@vhir.org
Contact: Andreea Ciudin, PhD +34 932744736 ext 4736 aciudin@vhebron.net

Locations
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Andreea Ciudin, PhD    +34932744736    aciudin@vhebron.net   
Contact: Cristina Hernandez, MD, PhD    +34 932746591    cristina.hernandez@vhir.org   
Principal Investigator: Cristina Hernandez, MD, PhD         
Sub-Investigator: Andreea Ciudin, MD         
Sub-Investigator: Olga Simó-Servat, MD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute

Publications:
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02501850     History of Changes
Other Study ID Numbers: VHI-GLP-2014-01
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Lipoprotein (a)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Lixisenatide
Metformin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists