Clinical trial NCT01715428: Liraglutide and Cardio-Metabolic Risk Markers
Official title: Effects of Liraglutide on Cardio-Metabolic Risk Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type-2 Diabetes
Keywords: diabetes, cardiovascular risk
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult subjects with type-2 diabetes

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.

Eligibility criteria: Inclusion Criteria:

- patients with a diagnosis of type-2 diabetes

Exclusion Criteria:

- severe hepatic or renal diseases

Primary outcomes:
measure: carotid intima-media thickness
timeFrame: every four months for a total period of 2 years
Secondary outcomes:
measure: changes in oxidative stress markers
timeFrame: after 2 months of therapy
measure: changes in plasma ghrelin concentrations and heat-shock proteins
timeFrame: after 2 months of therapy
measure: changes in atherogenic lipoproteins
timeFrame: after 2 and after 4 months of therapy
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: University Hospital of Palermo
Study officials:
affiliation: University of Palermo, Italy
name: Giuseppe Montalto, MD
role: STUDY_DIRECTOR
References:
citation: Nikolic D, Patti AM, Giglio RV, Chianetta R, Castellino G, Magan-Fernandez A, Citarrella R, Papanas N, Janez A, Stoian AP, Rizvi AA, Rizzo M. Liraglutide Improved Cardiometabolic Parameters More in Obese than in Non-obese Patients with Type 2 Diabetes: A Real-World 18-Month Prospective Study. Diabetes Ther. 2022 Mar;13(3):453-464. doi: 10.1007/s13300-022-01217-z. Epub 2022 Feb 15.
citation: Nikolic D, Giglio RV, Rizvi AA, Patti AM, Montalto G, Maranta F, Cianflone D, Stoian AP, Rizzo M. Liraglutide Reduces Carotid Intima-Media Thickness by Reducing Small Dense Low-Density Lipoproteins in a Real-World Setting of Patients with Type 2 Diabetes: A Novel Anti-Atherogenic Effect. Diabetes Ther. 2021 Jan;12(1):261-274. doi: 10.1007/s13300-020-00962-3. Epub 2020 Nov 18.
citation: Rizzo M, Rizvi AA, Patti AM, Nikolic D, Giglio RV, Castellino G, Li Volti G, Caprio M, Montalto G, Provenzano V, Genovese S, Ceriello A. Liraglutide improves metabolic parameters and carotid intima-media thickness in diabetic patients with the metabolic syndrome: an 18-month prospective study. Cardiovasc Diabetol. 2016 Dec 3;15(1):162. doi: 10.1186/s12933-016-0480-8.
citation: Rizvi AA, Patti AM, Giglio RV, Nikolic D, Amato A, Al-Busaidi N, Al-Rasadi K, Soresi M, Banach M, Montalto G, Rizzo M. Liraglutide improves carotid intima-media thickness in patients with type 2 diabetes and non-alcoholic fatty liver disease: an 8-month prospective pilot study. Expert Opin Biol Ther. 2015;15(10):1391-7. doi: 10.1517/14712598.2015.1067299. Epub 2015 Jul 20.
citation: Rizzo M, Abate N, Chandalia M, Rizvi AA, Giglio RV, Nikolic D, Marino Gammazza A, Barbagallo I, Isenovic ER, Banach M, Montalto G, Li Volti G. Liraglutide reduces oxidative stress and restores heme oxygenase-1 and ghrelin levels in patients with type 2 diabetes: a prospective pilot study. J Clin Endocrinol Metab. 2015 Feb;100(2):603-6. doi: 10.1210/jc.2014-2291. Epub 2014 Nov 13.
citation: Rizzo M, Chandalia M, Patti AM, Di Bartolo V, Rizvi AA, Montalto G, Abate N. Liraglutide decreases carotid intima-media thickness in patients with type 2 diabetes: 8-month prospective pilot study. Cardiovasc Diabetol. 2014 Feb 22;13:49. doi: 10.1186/1475-2840-13-49.