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

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.

Study Overview

Status

Unknown

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristina Hernandez, MD, PhD
        • Sub-Investigator:
          • Andreea Ciudin, MD
        • Sub-Investigator:
          • Olga Simó-Servat, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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)
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.
Treatment with metformin and/or sulphonilurea
Other Names:
  • sulphonilurea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in blood levels of Lipoprotein (a) (Lp(a))
Time Frame: Baseline and two months
Baseline and two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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