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Liraglutide and Cardio-Metabolic Risk Markers

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Palermo
Information provided by (Responsible Party):
Manfredi Rizzo, University of Palermo Identifier:
First received: October 23, 2012
Last updated: October 25, 2012
Last verified: October 2012

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)
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.


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


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 identifier: NCT01715428

Contact: Manfredi Rizzo, MD, PhD +390916552945

University Hospital of Palermo Recruiting
Palermo, Italy, 90127
Contact: Manfredi Rizzo, MD, PhD    +390916552945   
Principal Investigator: Manfredi Rizzo, MD, PhD         
Sponsors and Collaborators
University of Palermo
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 Identifier (NCT Number):
Responsible Party: Manfredi Rizzo, Assistant Professor, University of Palermo Identifier: NCT01715428     History of Changes
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, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 27, 2014