Cardiovascular DiseasesPhase 4NCT01797211
Mediterranean Diet and Endothelial Function
A Phase 4 study testing Mediterranean diet in people with Cardiovascular Diseases, run by University of Bari at 1 site in Italy.
Trial summary
To assess the effect of Mediterranean diet and some of its specific components (olive oil, non fried fish and nuts) on endothelial function in overweight and obese patients Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to May 2012
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI: > 25.0 kg/m2 Age between 18-70 years
Who cannot join
- BMI < 25.0 kg/m2 Age <18 or >70 years low left ventricular ejection fraction (LVEF < 50%) symptomatic cardiac disease in advanced stage or poorly controlled by medication cerebral disorders major liver and kidney diseases cancer excessive alcohol intake use of drugs addressed to lose weight.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, University of Bari
Bari, Bari, 70124
About this study
Official title: Mediterranean Diet and Endothelial Function in Obese and Overweight Patients: the Role of Olive Oil, Non Fried Fish and Nuts
To assess the effect of Mediterranean diet and some of its specific components (olive oil, non fried fish and nuts) on endothelial function in overweight and obese patients
Read the detailed description
Abdominal obesity is well known to increase the risk of cardiovascular disease (CVD), since it is commonly associated with hypertension, dyslipidemia, impaired fasting glucose, type 2 diabetes, metabolic syndrome, insulin resistance, systemic inflammation and endothelium dysfunction.
Abnormal endothelial function, expressed as lower vasodilatation through flow-mediated vasodilatation (FMD) of brachial artery in response to an increase in blood flow, is considered an index of subclinical atherosclerosis, and an early hallmark of cardiovascular disease, with a strong prognostic value for future cardiovascular events. Changes in diet, level of physical activity and behavior are well known key elements influence endothelial function. Recent studies seem to show that Mediterranean diet has beneficial role on cardiovascular risk. It could protect against the development of coronary heart disease also through a possible effect on body weight and obesity.
At the best of our knowledge, the effect of Mediterranean diet on endothelial function in obese subjects has not been definitely established. Therefore, the aim of this study was to evaluate the impact of Mediterranean diet on anthropometric parameters (body weight, BMI and waist circumference), lipid profile [total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C)], triglycerides (TG), fasting glucose and endothelium function, evaluated by FMD, in a group of obese and overweight subjects. In particular, subjects were invited to follow a standard Mediterranean diet for a short (3 months) or a longer (18 months) period. The specific role of some components of Mediterranean diet (olive oil or non fried fish or nuts) was also investigated.
- Conditions
- Cardiovascular Diseases
- Being tested
- Mediterranean diet
- Keywords
- Mediterranean diet; FMD; obesity; cardiovascular risk.
- Medical subject headings
- Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietDietary supplement
Patients underwent administration of Mediterranean diet and olive oil, or Mediterranean diet and not-fried fish, or Mediterranean diet and nuts.
| Study group | Role | What they receive |
|---|---|---|
| diet group A | Experimental | Mediterranean diet+olive oil Receives: Dietary Supplement: Mediterranean diet |
| Diet Group B | Experimental | Mediterranean diet+not-fried fish Receives: Dietary Supplement: Mediterranean diet |
| Diet Group C | Experimental | Mediterranean diet+nuts Receives: Dietary Supplement: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 months outcome (composite outcome)
Anthropometric parameters (BMI, waist circumference [WC] and weight) a significant decrease, while FMD ones showed a significant increase after 3 months of Mediterranean diet as compared to baseline levels. The addition per se of olive oil or non fried fish or nuts to the standard Mediterranean diet did not influence anthropometric parameters, since BMI, WC and body weight of groups A, B and C were not significant different from those of the control group. After 3 months, FMD was not higher wether olive oil or non fried fish or nuts were added to standard Mediterranean diet.
Measured: 3 months after enrollment
Secondary outcomes (1)
18 months follow-up evaluations (composite outcome)
After 18 months of dietary treatment, we observed a significant increase of HDL-C, a decrease of TC and LDL-C, no differences in TG plasma concentrations and fasting glucose. The addition per se of olive oil or non fried fish or nuts to the standard Mediterranean diet did not influence the lipid profile. Anthropometric parameters showed a significant decrease and FMD showed a significant increase after 18 months, as compared to 3 months levels. Olive oil, non fried fish or nuts to the standard Mediterranean diet did not influence anthropometric parameters, since BMI, WC and body weight of groups A, B and C were not significant different from those of the control group. It is noteworthy that, after 18 months of Mediterranean diet, but not after 3 months, FMD was higher wether olive oil or non fried fish or nuts were added to standard Mediterranean diet. Lastly, at 18 months, the FMD levels of groups A, B, and C were significantly higher than those of control group.
Measured: 18 months after enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJun 2010
- Primary completionApr 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. Marco Matteo Ciccone, University of Bari
- Investigators
- Marco M Ciccone, MD, Principal investigator, University of BariGiovanni De Pergola, MD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797211
- Sponsor's protocol ID
- 01
- Status last verified
- Feb 2013
- First submitted
- 15 Feb 2013
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Feletou M, Vanhoutte PM. Endothelium-derived hyperpolarizing factor: where are we now? Arterioscler Thromb Vasc Biol. 2006 Jun;26(6):1215-25. doi: 10.1161/01.ATV.0000217611.81085.c5. Epub 2006 Mar 16.
PubMed 16543495Yoshida T, Kawano H, Miyamoto S, Motoyama T, Fukushima H, Hirai N, Ogawa H. Prognostic value of flow-mediated dilation of the brachial artery in patients with cardiovascular disease. Intern Med. 2006;45(9):575-9. doi: 10.2169/internalmedicine.45.1534. Epub 2006 Jun 1.
PubMed 16755087Kastorini CM, Milionis HJ, Goudevenos JA, Panagiotakos DB. Mediterranean diet and coronary heart disease: is obesity a link? - A systematic review. Nutr Metab Cardiovasc Dis. 2010 Sep;20(7):536-51. doi: 10.1016/j.numecd.2010.04.006.
PubMed 20708148Babio N, Bullo M, Basora J, Martinez-Gonzalez MA, Fernandez-Ballart J, Marquez-Sandoval F, Molina C, Salas-Salvado J; Nureta-PREDIMED Investigators. Adherence to the Mediterranean diet and risk of metabolic syndrome and its components. Nutr Metab Cardiovasc Dis. 2009 Oct;19(8):563-70. doi: 10.1016/j.numecd.2008.10.007. Epub 2009 Jan 26.
PubMed 19176282Jambrik Z, Venneri L, Varga A, Rigo F, Borges A, Picano E. Peripheral vascular endothelial function testing for the diagnosis of coronary artery disease. Am Heart J. 2004 Oct;148(4):684-9. doi: 10.1016/j.ahj.2004.04.016.
PubMed 15459601Wildman RP, Muntner P, Reynolds K, McGinn AP, Rajpathak S, Wylie-Rosett J, Sowers MR. The obese without cardiometabolic risk factor clustering and the normal weight with cardiometabolic risk factor clustering: prevalence and correlates of 2 phenotypes among the US population (NHANES 1999-2004). Arch Intern Med. 2008 Aug 11;168(15):1617-24. doi: 10.1001/archinte.168.15.1617.
PubMed 18695075Hotchkiss JW, Leyland AH. The relationship between body size and mortality in the linked Scottish Health Surveys: cross-sectional surveys with follow-up. Int J Obes (Lond). 2011 Jun;35(6):838-51. doi: 10.1038/ijo.2010.207. Epub 2010 Oct 5.
PubMed 20921963von Ruesten A, Steffen A, Floegel A, van der A DL, Masala G, Tjonneland A, Halkjaer J, Palli D, Wareham NJ, Loos RJ, Sorensen TI, Boeing H. Trend in obesity prevalence in European adult cohort populations during follow-up since 1996 and their predictions to 2015. PLoS One. 2011;6(11):e27455. doi: 10.1371/journal.pone.0027455. Epub 2011 Nov 10.
PubMed 22102897Serdula MK, Mokdad AH, Williamson DF, Galuska DA, Mendlein JM, Heath GW. Prevalence of attempting weight loss and strategies for controlling weight. JAMA. 1999 Oct 13;282(14):1353-8. doi: 10.1001/jama.282.14.1353.
PubMed 10527182Romaguera D, Norat T, Vergnaud AC, Mouw T, May AM, Agudo A, Buckland G, Slimani N, Rinaldi S, Couto E, Clavel-Chapelon F, Boutron-Ruault MC, Cottet V, Rohrmann S, Teucher B, Bergmann M, Boeing H, Tjonneland A, Halkjaer J, Jakobsen MU, Dahm CC, Travier N, Rodriguez L, Sanchez MJ, Amiano P, Barricarte A, Huerta JM, Luan J, Wareham N, Key TJ, Spencer EA, Orfanos P, Naska A, Trichopoulou A, Palli D, Agnoli C, Mattiello A, Tumino R, Vineis P, Bueno-de-Mesquita HB, Buchner FL, Manjer J, Wirfalt E, Johansson I, Hellstrom V, Lund E, Braaten T, Engeset D, Odysseos A, Riboli E, Peeters PH. Mediterranean dietary patterns and prospective weight change in participants of the EPIC-PANACEA project. Am J Clin Nutr. 2010 Oct;92(4):912-21. doi: 10.3945/ajcn.2010.29482. Epub 2010 Sep 1.
PubMed 20810975Issa C, Darmon N, Salameh P, Maillot M, Batal M, Lairon D. A Mediterranean diet pattern with low consumption of liquid sweets and refined cereals is negatively associated with adiposity in adults from rural Lebanon. Int J Obes (Lond). 2011 Feb;35(2):251-8. doi: 10.1038/ijo.2010.130. Epub 2010 Jul 6.
PubMed 20603626de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999 Feb 16;99(6):779-85. doi: 10.1161/01.cir.99.6.779.
PubMed 9989963Robertson RM, Smaha L. Can a Mediterranean-style diet reduce heart disease? Circulation. 2001 Apr 3;103(13):1821-2. doi: 10.1161/01.cir.103.13.1821. No abstract available.
PubMed 11282917Perona JS, Cabello-Moruno R, Ruiz-Gutierrez V. The role of virgin olive oil components in the modulation of endothelial function. J Nutr Biochem. 2006 Jul;17(7):429-45. doi: 10.1016/j.jnutbio.2005.11.007. Epub 2005 Dec 12.
PubMed 16481154Massaro M, Basta G, Lazzerini G, Carluccio MA, Bosetti F, Solaini G, Visioli F, Paolicchi A, De Caterina R. Quenching of intracellular ROS generation as a mechanism for oleate-induced reduction of endothelial activation and early atherogenesis. Thromb Haemost. 2002 Aug;88(2):335-44.
PubMed 12195709
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet and Endothelial Function in Obese and Overweight Patients: the Role of Olive Oil, Non Fried Fish and Nuts
- ClinicalTrials.gov ID
- NCT01797211
- Acronym / sponsor ID
- 01
- Conditions
- Cardiovascular Diseases
- Keywords
- Mediterranean diet; FMD; obesity; cardiovascular risk.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Feb 2013 (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.
To assess the effect of Mediterranean diet and some of its specific components (olive oil, non fried fish and nuts) on endothelial function in overweight and obese patients
Detailed description
Abdominal obesity is well known to increase the risk of cardiovascular disease (CVD), since it is commonly associated with hypertension, dyslipidemia, impaired fasting glucose, type 2 diabetes, metabolic syndrome, insulin resistance, systemic inflammation and endothelium dysfunction.
Abnormal endothelial function, expressed as lower vasodilatation through flow-mediated vasodilatation (FMD) of brachial artery in response to an increase in blood flow, is considered an index of subclinical atherosclerosis, and an early hallmark of cardiovascular disease, with a strong prognostic value for future cardiovascular events. Changes in diet, level of physical activity and behavior are well known key elements influence endothelial function. Recent studies seem to show that Mediterranean diet has beneficial role on cardiovascular risk. It could protect against the development of coronary heart disease also through a possible effect on body weight and obesity.
At the best of our knowledge, the effect of Mediterranean diet on endothelial function in obese subjects has not been definitely established. Therefore, the aim of this study was to evaluate the impact of Mediterranean diet on anthropometric parameters (body weight, BMI and waist circumference), lipid profile [total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C)], triglycerides (TG), fasting glucose and endothelium function, evaluated by FMD, in a group of obese and overweight subjects. In particular, subjects were invited to follow a standard Mediterranean diet for a short (3 months) or a longer (18 months) period. The specific role of some components of Mediterranean diet (olive oil or non fried fish or nuts) was also investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diet group A | Experimental | Dietary Supplement: Mediterranean dietMediterranean diet+olive oil |
| Diet Group B | Experimental | Dietary Supplement: Mediterranean dietMediterranean diet+not-fried fish |
| Diet Group C | Experimental | Dietary Supplement: Mediterranean dietMediterranean diet+nuts |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI: > 25.0 kg/m2 Age between 18-70 years
Key exclusion criteria (1 listed)
- BMI < 25.0 kg/m2 Age <18 or >70 years low left ventricular ejection fraction (LVEF < 50%) symptomatic cardiac disease in advanced stage or poorly controlled by medication cerebral disorders major liver and kidney diseases cancer excessive alcohol intake use of drugs addressed to lose weight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean dietPatients underwent administration of Mediterranean diet and olive oil, or Mediterranean diet and not-fried fish, or Mediterranean diet and nuts. | Dietary supplement | Diet Group B, Diet Group C, diet group A |
Primary outcome
3 months outcome (composite outcome)
Time frame: 3 months after enrollment
Anthropometric parameters (BMI, waist circumference [WC] and weight) a significant decrease, while FMD ones showed a significant increase after 3 months of Mediterranean diet as compared to baseline levels. The addition per se of olive oil or non fried fish or nuts to the standard Mediterranean diet did not influence anthropometric parameters, since BMI, WC and body weight of groups A, B and C were not significant different from those of the control group. After 3 months, FMD was not higher wether olive oil or non fried fish or nuts were added to standard Mediterranean diet.
1 secondary outcome
18 months follow-up evaluations (composite outcome)
Time frame: 18 months after enrollment period
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 Feb 2013.
- Background: PubMed 16543495Feletou M, Vanhoutte PM. Endothelium-derived hyperpolarizing factor: where are we now? Arterioscler Thromb Vasc Biol. 2006 Jun;26(6):1215-25. doi: 10.1161/01.ATV.0000217611.81085.c5. Epub 2006 Mar 16.
- Background: PubMed 16755087Yoshida T, Kawano H, Miyamoto S, Motoyama T, Fukushima H, Hirai N, Ogawa H. Prognostic value of flow-mediated dilation of the brachial artery in patients with cardiovascular disease. Intern Med. 2006;45(9):575-9. doi: 10.2169/internalmedicine.45.1534. Epub 2006 Jun 1.
- Results publication: PubMed 20708148Kastorini CM, Milionis HJ, Goudevenos JA, Panagiotakos DB. Mediterranean diet and coronary heart disease: is obesity a link? - A systematic review. Nutr Metab Cardiovasc Dis. 2010 Sep;20(7):536-51. doi: 10.1016/j.numecd.2010.04.006.
- Results publication: PubMed 19176282Babio N, Bullo M, Basora J, Martinez-Gonzalez MA, Fernandez-Ballart J, Marquez-Sandoval F, Molina C, Salas-Salvado J; Nureta-PREDIMED Investigators. Adherence to the Mediterranean diet and risk of metabolic syndrome and its components. Nutr Metab Cardiovasc Dis. 2009 Oct;19(8):563-70. doi: 10.1016/j.numecd.2008.10.007. Epub 2009 Jan 26.
- Results publication: PubMed 15459601Jambrik Z, Venneri L, Varga A, Rigo F, Borges A, Picano E. Peripheral vascular endothelial function testing for the diagnosis of coronary artery disease. Am Heart J. 2004 Oct;148(4):684-9. doi: 10.1016/j.ahj.2004.04.016.
- Results publication: PubMed 18695075Wildman RP, Muntner P, Reynolds K, McGinn AP, Rajpathak S, Wylie-Rosett J, Sowers MR. The obese without cardiometabolic risk factor clustering and the normal weight with cardiometabolic risk factor clustering: prevalence and correlates of 2 phenotypes among the US population (NHANES 1999-2004). Arch Intern Med. 2008 Aug 11;168(15):1617-24. doi: 10.1001/archinte.168.15.1617.
- Results publication: PubMed 20921963Hotchkiss JW, Leyland AH. The relationship between body size and mortality in the linked Scottish Health Surveys: cross-sectional surveys with follow-up. Int J Obes (Lond). 2011 Jun;35(6):838-51. doi: 10.1038/ijo.2010.207. Epub 2010 Oct 5.
- Results publication: PubMed 22102897von Ruesten A, Steffen A, Floegel A, van der A DL, Masala G, Tjonneland A, Halkjaer J, Palli D, Wareham NJ, Loos RJ, Sorensen TI, Boeing H. Trend in obesity prevalence in European adult cohort populations during follow-up since 1996 and their predictions to 2015. PLoS One. 2011;6(11):e27455. doi: 10.1371/journal.pone.0027455. Epub 2011 Nov 10.
- Results publication: PubMed 10527182Serdula MK, Mokdad AH, Williamson DF, Galuska DA, Mendlein JM, Heath GW. Prevalence of attempting weight loss and strategies for controlling weight. JAMA. 1999 Oct 13;282(14):1353-8. doi: 10.1001/jama.282.14.1353.
- Results publication: PubMed 20810975Romaguera D, Norat T, Vergnaud AC, Mouw T, May AM, Agudo A, Buckland G, Slimani N, Rinaldi S, Couto E, Clavel-Chapelon F, Boutron-Ruault MC, Cottet V, Rohrmann S, Teucher B, Bergmann M, Boeing H, Tjonneland A, Halkjaer J, Jakobsen MU, Dahm CC, Travier N, Rodriguez L, Sanchez MJ, Amiano P, Barricarte A, Huerta JM, Luan J, Wareham N, Key TJ, Spencer EA, Orfanos P, Naska A, Trichopoulou A, Palli D, Agnoli C, Mattiello A, Tumino R, Vineis P, Bueno-de-Mesquita HB, Buchner FL, Manjer J, Wirfalt E, Johansson I, Hellstrom V, Lund E, Braaten T, Engeset D, Odysseos A, Riboli E, Peeters PH. Mediterranean dietary patterns and prospective weight change in participants of the EPIC-PANACEA project. Am J Clin Nutr. 2010 Oct;92(4):912-21. doi: 10.3945/ajcn.2010.29482. Epub 2010 Sep 1.
- Results publication: PubMed 20603626Issa C, Darmon N, Salameh P, Maillot M, Batal M, Lairon D. A Mediterranean diet pattern with low consumption of liquid sweets and refined cereals is negatively associated with adiposity in adults from rural Lebanon. Int J Obes (Lond). 2011 Feb;35(2):251-8. doi: 10.1038/ijo.2010.130. Epub 2010 Jul 6.
- Results publication: PubMed 9989963de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999 Feb 16;99(6):779-85. doi: 10.1161/01.cir.99.6.779.
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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.
Marco M Ciccone, MD principal investigator
University of Bari
Giovanni De Pergola, MD principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mediterranean diet in people with Cardiovascular Diseases, run by University of Bari 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 Feb 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
3 months outcome (composite outcome) (time frame: 3 months after enrollment). 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 NCT01797211, which also lists 23 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 Feb 2013.