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Completed

NCT Number: NCT01715428

Liraglutide and Cardio-Metabolic Risk Markers

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.

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Key information

Conditions

Type-2 Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Palermo

Palermo, 90127, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with a diagnosis of type-2 diabetes

Exclusion criteria

  • severe hepatic or renal diseases

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Effects of Liraglutide on Cardio-Metabolic Risk Markers

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 29, 2012
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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