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

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT02501850
Phase
PHASE4
Status
Unknown

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
50 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Treatment with liraglutide, exenatide or lixisenatide
  • metformin — DRUG
    Treatment with metformin and/or sulphonilurea

Study Details

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.

Key Dates

Start date
Oct 31, 2014
Status verified
Jul 2015
Primary completion
Jul 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)
  • Active Comparator: Group B
    Type 2 diabetic patients whom were prescribed metformin and/or sulphonilurea, according to usual clinical practice.

Primary Outcome Measure

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

Central Contacts

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