NCT01715428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

3.5 years

First QC Date

October 23, 2012

Last Update Submit

November 20, 2017

Conditions

Type-2 Diabetes

Keywords

diabetes, cardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • changes in oxidative stress markers

    after 2 months of therapy

  • changes in plasma ghrelin concentrations and heat-shock proteins

    after 2 months of therapy

  • changes in atherogenic lipoproteins

    after 2 and after 4 months of therapy

Study Arms (1)

Liraglutide

administration of liraglutide at 1.2 mg/daily

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult subjects with type-2 diabetes

You may qualify if:

  • \- patients with a diagnosis of type-2 diabetes

You may not qualify if:

  • \- severe hepatic or renal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Palermo

Palermo, 90127, Italy

Location

Related Publications (6)

  • 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.

    PMID: 35167051DERIVED

  • 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.

    PMID: 33210276DERIVED

  • 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.

    PMID: 27912784DERIVED

  • 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.

    PMID: 26195184DERIVED

  • 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.

    PMID: 25393640DERIVED

  • 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.

    PMID: 24559258DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum and plasma samples

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Giuseppe Montalto, MD

    University of Palermo, Italy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 29, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 22, 2017

Record last verified: 2017-11

Locations

IT(1)