Type-2 DiabetesNCT01715428
Liraglutide and Cardio-Metabolic Risk Markers
An observational study of Type-2 Diabetes, run by University of Palermo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type-2 Diabetes
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult subjects with type-2 diabetes
Who may be able to join
- patients with a diagnosis of type-2 diabetes
Who cannot join
- severe hepatic or renal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Liraglutide on 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.
Read the detailed description
In details, we will evaluate the effects of liraglutide on carotid-intima media thickness, oxidative stress, ghrelin, heat shock proteins and lipoproteins.
- Conditions
- Type-2 Diabetes
- Keywords
- diabetes, cardiovascular risk
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | administration of liraglutide at 1.2 mg/daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid intima-media thickness
carotid intima-media thickness will be assessed by doppler ultrasonography
Measured: every four months for a total period of 2 years
Secondary outcomes (3)
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).
Measured: after 2 months of therapy
changes in plasma ghrelin concentrations and heat-shock proteins
plasma ghrelin concentrations and heat shock protein 60 were measured by ELISA
Measured: after 2 months of therapy
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)
Measured: after 2 and after 4 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type-2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfredi Rizzo, University of Palermo
- Investigators
- Giuseppe Montalto, MD, Study director, University of Palermo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715428
- Sponsor's protocol ID
- LIRAGLUTIDE UNIPA
- Status last verified
- Nov 2017
- First submitted
- 23 Oct 2012
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35167051Nikolic 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.
PubMed 33210276Rizzo 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.
PubMed 27912784Rizvi 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.
PubMed 26195184Rizzo 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.
PubMed 25393640Rizzo 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.
PubMed 24559258
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liraglutide on Cardio-Metabolic Risk Markers
- ClinicalTrials.gov ID
- NCT01715428
- Acronym / sponsor ID
- LIRAGLUTIDE UNIPA
- Conditions
- Type-2 Diabetes
- Keywords
- diabetes, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | – | –administration of liraglutide at 1.2 mg/daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult subjects with type-2 diabetes
Key inclusion criteria (1 listed)
- patients with a diagnosis of type-2 diabetes
Key exclusion criteria (1 listed)
- severe hepatic or renal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
changes in oxidative stress markers
Time frame: after 2 months of therapy
changes in plasma ghrelin concentrations and heat-shock proteins
Time frame: after 2 months of therapy
changes in atherogenic lipoproteins
Time frame: after 2 and after 4 months of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Derived from this study: PubMed 35167051Nikolic 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.
- Derived from this study: PubMed 33210276Nikolic 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.
- Derived from this study: PubMed 27912784Rizzo 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.
- Derived from this study: PubMed 26195184Rizvi 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.
- Derived from this study: PubMed 25393640Rizzo 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.
- Derived from this study: PubMed 24559258Rizzo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Montalto, MD study director
University of Palermo, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type-2 Diabetes, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid intima-media thickness (time frame: every four months for a total period of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715428, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.