NCT02501850

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

July 16, 2015

Last Update Submit

July 20, 2015

Conditions

Diabetes Mellitus Type 2

Keywords

Lipoprotein (a)

Outcome Measures

Primary Outcomes (1)

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

    Baseline and two months

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

Type 2 diabetic patients whom were prescribed metformin and/or sulphonilurea, according to usual clinical practice.

Drug: metformin

Interventions

LiraglutideDRUG

Treatment with liraglutide, exenatide or lixisenatide

Also known as: Exenatide, Lixisenatide
Group A
metforminDRUG

Treatment with metformin and/or sulphonilurea

Also known as: sulphonilurea
Group B

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Related Publications (3)

  • Hernandez C, Francisco G, Chacon P, Simo R. Lipoprotein(a) as a risk factor for cardiovascular mortality in type 2 diabetic patients: a 10-year follow-up study. Diabetes Care. 2005 Apr;28(4):931-3. doi: 10.2337/diacare.28.4.931. No abstract available.

    PMID: 15793200BACKGROUND

  • Hernandez C, Francisco G, Chacon P, Mesa J, Simo R. Biological variation of lipoprotein(a) in a diabetic population. Analysis of the causes and clinical implications. Clin Chem Lab Med. 2003 Aug;41(8):1075-80. doi: 10.1515/CCLM.2003.166.

    PMID: 12964817BACKGROUND

  • Genser B, Dias KC, Siekmeier R, Stojakovic T, Grammer T, Maerz W. Lipoprotein (a) and risk of cardiovascular disease--a systematic review and meta analysis of prospective studies. Clin Lab. 2011;57(3-4):143-56.

    PMID: 21500721BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LiraglutideExenatidelixisenatideMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsBiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Cristina Hernandez, MD, PhD

CONTACT

+34 934894172cristina.hernandez@vhir.org

Andreea Ciudin, PhD

CONTACT

+34 932744736aciudin@vhebron.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 17, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

ES(1)