Liraglutide and Cardio-Metabolic Risk Markers

This study is currently recruiting participants.
Verified October 2012 by University of Palermo
Sponsor:
Information provided by (Responsible Party):
Manfredi Rizzo, University of Palermo
ClinicalTrials.gov Identifier:
NCT01715428
First received: October 23, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

Incretin-based therapies have shown significant effects beyond those on glucose metabolism. We aim in the present study to evaluate the effects of liraglutide on several cardio-metabolic risk markers.


Condition Phase
Type-2 Diabetes
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Liraglutide on Cardio-Metabolic Risk Markers

Resource links provided by NLM:


Further study details as provided by University of Palermo:

Primary Outcome Measures:
  • carotid intima-media thickness [ Time Frame: every four months for a total period of 2 years ] [ Designated as safety issue: No ]
    carotid intima-media thickness will be assessed by doppler ultrasonography


Secondary Outcome Measures:
  • changes in oxidative stress, ghrelin, atherogenic lipoproteins, heat shock proteins [ Time Frame: after 2 months of therapy ] [ Designated as safety issue: No ]
    oxidative stress, ghrelin, atherogenic lipoproteins, heat shock proteins will be measured by high-quality technologies


Biospecimen Retention:   Samples With DNA

serum and plasma samples


Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Liraglutide
administration of liraglutide at 1.2 mg/daily

Detailed Description:

In details, we will evaluate the effects of liraglutide on carotid-intima media thickness, oxidative stress, ghrelin, heat shock proteins and lipoproteins.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adult subjects with type-2 diabetes

Criteria

Inclusion Criteria:

- patients with a diagnosis of type-2 diabetes

Exclusion Criteria:

- severe hepatic or renal diseases

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715428

Contacts
Contact: Manfredi Rizzo, MD, PhD +390916552945 manfredi.rizzo@unipa.it

Locations
Italy
University Hospital of Palermo Recruiting
Palermo, Italy, 90127
Contact: Manfredi Rizzo, MD, PhD    +390916552945    manfredi.rizzo@unipa.it   
Principal Investigator: Manfredi Rizzo, MD, PhD         
Sponsors and Collaborators
University of Palermo
Investigators
Study Director: Giuseppe Montalto, MD University of Palermo, Italy
  More Information

No publications provided

Responsible Party: Manfredi Rizzo, Assistant Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT01715428     History of Changes
Other Study ID Numbers: LIRAGLUTIDE UNIPA
Study First Received: October 23, 2012
Last Updated: October 25, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Palermo:
diabetes, cardiovascular risk

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014