Liraglutide and Cardio-Metabolic Risk Markers

Type-2 Diabetes Clinical Trial

Official title:

Effects of Liraglutide on Cardio-Metabolic Risk Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715428
• Other study ID #: LIRAGLUTIDE UNIPA
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: November 20, 2017
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2017
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with a diagnosis of type-2 diabetes

Exclusion Criteria:

• severe hepatic or renal diseases

Related Conditions & MeSH terms

• Type-2 Diabetes

Locations

Country	Name	City	State
Italy	University Hospital of Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	carotid intima-media thickness	carotid intima-media thickness will be assessed by doppler ultrasonography	every four months for a total period of 2 years
Secondary	changes in oxidative stress markers	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).	after 2 months of therapy
Secondary	changes in plasma ghrelin concentrations and heat-shock proteins	plasma ghrelin concentrations and heat shock protein 60 were measured by ELISA	after 2 months of therapy
Secondary	changes in atherogenic lipoproteins	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)	after 2 and after 4 months of therapy