Liraglutide and Cardio-Metabolic Risk Markers
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ClinicalTrials.gov Identifier: NCT01715428 |
Recruitment Status :
Completed
First Posted : October 29, 2012
Last Update Posted : November 22, 2017
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Condition or disease |
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Type-2 Diabetes |
Study Type : | Observational |
Actual Enrollment : | 300 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Effects of Liraglutide on Cardio-Metabolic Risk Markers |
Actual Study Start Date : | June 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Group/Cohort |
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Liraglutide
administration of liraglutide at 1.2 mg/daily
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- 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
- 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- patients with a diagnosis of type-2 diabetes
Exclusion Criteria:
- severe hepatic or renal diseases

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
Italy | |
University Hospital of Palermo | |
Palermo, Italy, 90127 |
Study Director: | Giuseppe Montalto, MD | University of Palermo, Italy |
Responsible Party: | Manfredi Rizzo, Assistant Professor, University of Palermo |
ClinicalTrials.gov Identifier: | NCT01715428 |
Other Study ID Numbers: |
LIRAGLUTIDE UNIPA |
First Posted: | October 29, 2012 Key Record Dates |
Last Update Posted: | November 22, 2017 |
Last Verified: | November 2017 |
diabetes, cardiovascular risk |