Liraglutide and Cardio-Metabolic Risk Markers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2015 by Manfredi Rizzo, University of Palermo.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Manfredi Rizzo, University of Palermo

ClinicalTrials.gov Identifier:

NCT01715428

First received: October 23, 2012

Last updated: June 2, 2015

Last verified: June 2015

History of Changes

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	Phase
Type-2 Diabetes	Phase 3


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:

Drug Information available for: Liraglutide

U.S. FDA Resources

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, ghrelin, atherogenic lipoproteins, heat shock proteins [ Time Frame: after 2 months of therapy ]
oxidative stress, ghrelin, atherogenic lipoproteins, heat shock proteins will be measured by high-quality technologies

Biospecimen Retention: Samples With DNA

serum and plasma samples


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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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):

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.

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.

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.

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.


Responsible Party:	Manfredi Rizzo, Assistant Professor, University of Palermo
ClinicalTrials.gov Identifier:	NCT01715428 History of Changes
Other Study ID Numbers:	LIRAGLUTIDE UNIPA
Study First Received:	October 23, 2012
Last Updated:	June 2, 2015

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

ClinicalTrials.gov processed this record on July 24, 2017

To Top