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Liraglutide and Cardio-Metabolic Risk Markers

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Manfredi Rizzo, University of Palermo Identifier:
First received: October 23, 2012
Last updated: June 2, 2015
Last verified: June 2015
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 Manfredi Rizzo, University of Palermo:

Primary Outcome Measures:
  • carotid intima-media thickness [ Time Frame: every four months for a total period of 2 years ]
    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 ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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Please refer to this study by its identifier: NCT01715428

University Hospital of Palermo
Palermo, Italy, 90127
Sponsors and Collaborators
University of Palermo
Study Director: Giuseppe Montalto, MD University of Palermo, Italy
  More Information

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: June 2, 2015

Keywords provided by Manfredi Rizzo, University of Palermo:
diabetes, cardiovascular risk

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017