- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02501850
The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a) (EGLIPA)
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Cristina Hernandez, MD, PhD
- Phone Number: 4172 +34 934894172
- Email: cristina.hernandez@vhir.org
Study Contact Backup
- Name: Andreea Ciudin, PhD
- Phone Number: 4736 +34 932744736
- Email: aciudin@vhebron.net
Study Locations
-
-
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitari Vall d'Hebron
-
Contact:
- Andreea Ciudin, PhD
- Phone Number: +34932744736
- Email: aciudin@vhebron.net
-
Contact:
- Cristina Hernandez, MD, PhD
- Phone Number: +34 932746591
- Email: cristina.hernandez@vhir.org
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Principal Investigator:
- Cristina Hernandez, MD, PhD
-
Sub-Investigator:
- Andreea Ciudin, MD
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Sub-Investigator:
- Olga Simó-Servat, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Obesity Agents
- Incretins
- Liraglutide
- Metformin
- Exenatide
- Lixisenatide
Other Study ID Numbers
- VHI-GLP-2014-01
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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