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Liraglutide and Cardio-Metabolic Risk Markers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01715428
First Posted: October 29, 2012
Last Update Posted: November 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manfredi Rizzo, University of Palermo
  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
Type-2 Diabetes

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 markers [ Time Frame: after 2 months of therapy ]
    Serum LOOH levels were evaluated following the oxidation of Fe2+ to Fe3+ in the presence of xylenol orange at 560 nm. Levels of GSH were measured in serum using a spectrophotometric assay based on the reaction of thiol groups with 2,2-dithio-bis-nitrobenzoic acid, while the production of ROS was assessed using fluorescent probe dihydroethidium staining (Sigma).

  • changes in plasma ghrelin concentrations and heat-shock proteins [ Time Frame: after 2 months of therapy ]
    plasma ghrelin concentrations and heat shock protein 60 were measured by ELISA

  • changes in atherogenic lipoproteins [ Time Frame: after 2 and after 4 months of therapy ]
    the full LDL subclass profile (from larger and less atherogenic LDL-1 and LDL-2, to smaller denser LDL-3 to LDL-7) was assessed by gel electrophoresis (Lipoprint, Quantimetrix, USA)


Biospecimen Retention:   Samples With DNA
serum and plasma samples

Enrollment: 300
Actual Study Start Date: June 2012
Study Completion Date: December 2015
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

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

- patients with a diagnosis of type-2 diabetes

Exclusion Criteria:

- severe hepatic or renal diseases

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715428


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

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
First Submitted: October 23, 2012
First Posted: October 29, 2012
Last Update Posted: November 22, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists