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Liraglutide and Cardio-Metabolic Risk Markers

Completed
Conditions
Type-2 Diabetes
Registration Number
NCT01715428
Lead Sponsor
University of Palermo
Brief Summary

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.

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
300
Inclusion Criteria
  • patients with a diagnosis of type-2 diabetes
Exclusion Criteria
  • severe hepatic or renal diseases

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
carotid intima-media thicknessevery four months for a total period of 2 years

carotid intima-media thickness will be assessed by doppler ultrasonography

Secondary Outcome Measures
NameTimeMethod
changes in plasma ghrelin concentrations and heat-shock proteinsafter 2 months of therapy

plasma ghrelin concentrations and heat shock protein 60 were measured by ELISA

changes in oxidative stress markersafter 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 atherogenic lipoproteinsafter 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)

Trial Locations

Locations (1)

University Hospital of Palermo

🇮🇹

Palermo, Italy

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