Current partner codePEPTIDESDE
NCT02501850·Phase 4·INTERVENTIONAL

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

Status

Unknown

Phase

Phase 4

Enrollment

40

Locations

1

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Liraglutide

Treatment with liraglutide, exenatide or lixisenatide

DRUG

metformin

Treatment with metformin and/or sulphonilurea

Timeline

From registration to results.

  1. First posted

    Jul 17, 2015

  2. Study start

    Oct 2014

  3. Primary completion

    Jul 2015

  4. Study completion

    Oct 2015

  5. Results posted

    Not reported

  6. Registry updated

    Jul 21, 2015

Outcomes

What the study measures.

Primary outcomes

Change in blood levels of Lipoprotein (a) (Lp(a))

Time frame · Baseline and two months

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
50 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

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