Liraglutide and Cardio-Metabolic Risk Markers

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Palermo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014