Metabolic SyndromeATTEMPTNCT00416741
Assessing The Treatment Effect in Metabolic Syndrome Without Perceptible diabeTes (ATTEMPT)
An observational study of Metabolic Syndrome, run by Hellenic Atherosclerosis Society at 1 site in Greece.
Trial summary
The objective of this protocol is to improve awareness, treatment, and control of metabolic syndrome, within primary prevention of cardiovascular disease, by implementing guidelines, after training of the participating physicians. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Implementation of guidelines
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2005to Feb 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metabolic Syndrome (NCEP ATP III Definition modified to AHA/NHLBI definition)
Who may be able to join
- Metabolic Syndrome (NCEP ATP III Definition modified to AHA/NHLBI definition)
Who cannot join
- Pregnancy
- Lactation
- Malignancies with small life expectancy
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hellenic Atherosclerosis Society
Thessaloniki, Thessaloniki, 55132
About this study
The objective of this protocol is to improve awareness, treatment, and control of metabolic syndrome, within primary prevention of cardiovascular disease, by implementing guidelines, after training of the participating physicians.
Read the detailed description
Physicians from 20 hospitals or health centres (primary and secondary health care settings) were trained to implement guidelines in treating metabolic syndrome.
There will be a baseline recording of patients with metabolic syndrome and then physicians will have to complete a one page form (by ticking pre-specified boxes) about the baseline status of the patients and will have to report the measures they took to improve awareness, treatment, and effective control of the metabolic syndrome. With 6 month intervals (up to 36 months at study completion) physicians will have to complete the same form. Previous training of physicians and the fact that they will have to report their success in treating metabolic syndrome will hopefully contribute to an increase in number of patients with the syndrome at treatment targets, and will minimise the target organ damage (i.e cardiovascular disease). The estimated 10-year reduction in coronary heart disease risk will be evaluated by a comparison of this risk (as evaluated by a risk engine, i.e. PROCAM) at the 6th month and at study completion with that of baseline.
- Conditions
- Metabolic Syndrome
- Being tested
- Implementation of guidelines
- Keywords
- Metabolic Syndrome, Obesity, Hyperlipidemia, High blood pressure, Diabetes
- Medical subject headings
- Metabolic Syndrome, Obesity, Hyperlipidemias, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of guidelinesBehavioural
Attaining targets for LDL cholesterol, arterial blood pressure, fasting [plasma flucose
| Study group | Role | What they receive |
|---|---|---|
| 1 Usual Care-Lifestyle counseling | Metabolic syndrome Receives: Behavioral: Implementation of guidelines | |
| 2 Intensive care-Lifestyle counseling | Metabolic Syndrome Implementation of guidelines Receives: Behavioral: Implementation of guidelines |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startFeb 2005
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Atherosclerosis Society
- Sponsor type
- University, hospital or other
- Investigators
- Vasilios G Athyros, MD, Study chair, Clinical Trials Chair of Hellenic Atherosclerosis SocietyMoses - Elisaf, MD, Study director, Clinical Trials Director of Hellenic Atherosclerosis Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416741
- Sponsor's protocol ID
- HAS-01-231206
- Acronym
- ATTEMPT
- Status last verified
- Jun 2011
- First submitted
- 27 Dec 2006
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Athyros VG, Ganotakis ES, Elisaf MS, Liberopoulos EN, Goudevenos IA, Karagiannis A; GREECE-METS Collaborative Group. Prevalence of vascular disease in metabolic syndrome using three proposed definitions. Int J Cardiol. 2007 Apr 25;117(2):204-10. doi: 10.1016/j.ijcard.2006.04.078. Epub 2006 Jul 18.
PubMed 16854482Daskalopoulou SS, Athyros VG, Kolovou GD, Anagnostopoulou KK, Mikhailidis DP. Definitions of metabolic syndrome: Where are we now? Curr Vasc Pharmacol. 2006 Jul;4(3):185-97. doi: 10.2174/157016106777698450.
PubMed 16842136Athyros VG, Ganotakis ES, Bathianaki M, Monedas I, Goudevenos IA, Papageorgiou AA, Papathanasiou A, Kakafika AI, Mikhailidis DP, Elisaf M; MetS-Greece Collaborative Group. Awareness, treatment and control of the metabolic syndrome and its components: a multicentre Greek study. Hellenic J Cardiol. 2005 Nov-Dec;46(6):380-6.
PubMed 16422124Athyros VG, Mikhailidis DP, Papageorgiou AA, Didangelos TP, Peletidou A, Kleta D, Karagiannis A, Kakafika AI, Tziomalos K, Elisaf M. Targeting vascular risk in patients with metabolic syndrome but without diabetes. Metabolism. 2005 Aug;54(8):1065-74. doi: 10.1016/j.metabol.2005.03.010.
PubMed 16092057Athyros VG, Karagiannis A, Ganotakis ES, Paletas K, Nicolaou V, Bacharoudis G, Tziomalos K, Alexandrides T, Liberopoulos EN, Mikhailidis DP; Assessing The Treatment Effect in Metabolic syndrome without Perceptible diabeTes (ATTEMPT) Collaborative Group. Association between the changes in renal function and serum uric acid levels during multifactorial intervention and clinical outcome in patients with metabolic syndrome. A post hoc analysis of the ATTEMPT study. Curr Med Res Opin. 2011 Aug;27(8):1659-68. doi: 10.1185/03007995.2011.595782. Epub 2011 Jun 30.
PubMed 21714711Athyros VG, Ganotakis E, Kolovou GD, Nicolaou V, Achimastos A, Bilianou E, Alexandrides T, Karagiannis A, Paletas K, Liberopoulos EN, Tziomalos K, Petridis D, Kakafika A, Elisaf MS, Mikhailidis DP; Assessing The Treatment Effect in Metabolic Syndrome Without Perceptible Diabetes (ATTEMPT) Collaborative. Assessing the treatment effect in metabolic syndrome without perceptible diabetes (ATTEMPT): a prospective-randomized study in middle aged men and women. Curr Vasc Pharmacol. 2011 Nov;9(6):647-57. doi: 10.2174/157016111797484080.
PubMed 21476961Chimonas T, Athyros VG, Ganotakis E, Nicolaou V, Panagiotakos DB, Mikhailidis DP, Elisaf M; Assessing the Treatment Effect in Metabolic Syndrome Without Perceptible diabeTes (ATTEMPT) Collaborative Group. Cardiovascular risk factors and estimated 10-year risk of fatal cardiovascular events using various equations in Greeks with metabolic syndrome. Angiology. 2010 Feb-Mar;61(1):49-57. doi: 10.1177/0003319709351873.
PubMed 20034959
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing The Treatment Effect in Metabolic Syndrome Without Perceptible diabeTes (ATTEMPT)
- ClinicalTrials.gov ID
- NCT00416741
- Acronym / sponsor ID
- ATTEMPT / HAS-01-231206
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Obesity, Hyperlipidemia, High blood pressure, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Hellenic Atherosclerosis SocietyUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Dec 2006 (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.
The objective of this protocol is to improve awareness, treatment, and control of metabolic syndrome, within primary prevention of cardiovascular disease, by implementing guidelines, after training of the participating physicians.
Detailed description
Physicians from 20 hospitals or health centres (primary and secondary health care settings) were trained to implement guidelines in treating metabolic syndrome.
There will be a baseline recording of patients with metabolic syndrome and then physicians will have to complete a one page form (by ticking pre-specified boxes) about the baseline status of the patients and will have to report the measures they took to improve awareness, treatment, and effective control of the metabolic syndrome. With 6 month intervals (up to 36 months at study completion) physicians will have to complete the same form. Previous training of physicians and the fact that they will have to report their success in treating metabolic syndrome will hopefully contribute to an increase in number of patients with the syndrome at treatment targets, and will minimise the target organ damage (i.e cardiovascular disease). The estimated 10-year reduction in coronary heart disease risk will be evaluated by a comparison of this risk (as evaluated by a risk engine, i.e. PROCAM) at the 6th month and at study completion with that of baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Usual Care-Lifestyle counseling | – | Behavioral: Implementation of guidelinesMetabolic syndrome |
| 2 Intensive care-Lifestyle counseling | – | Behavioral: Implementation of guidelinesMetabolic Syndrome Implementation of guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metabolic Syndrome (NCEP ATP III Definition modified to AHA/NHLBI definition)
Key inclusion criteria (1 listed)
- Metabolic Syndrome (NCEP ATP III Definition modified to AHA/NHLBI definition)
Key exclusion criteria (4 listed)
- Pregnancy
- Lactation
- Malignancies with small life expectancy
- Unwillingness to participate
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 |
|---|---|---|
| Implementation of guidelinesAttaining targets for LDL cholesterol, arterial blood pressure, fasting [plasma flucose | Behavioural | 1 Usual Care-Lifestyle counseling, 2 Intensive care-Lifestyle counseling |
Primary outcome
Not reported in the source record.
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 27 Jun 2011.
- Background: PubMed 16854482Athyros VG, Ganotakis ES, Elisaf MS, Liberopoulos EN, Goudevenos IA, Karagiannis A; GREECE-METS Collaborative Group. Prevalence of vascular disease in metabolic syndrome using three proposed definitions. Int J Cardiol. 2007 Apr 25;117(2):204-10. doi: 10.1016/j.ijcard.2006.04.078. Epub 2006 Jul 18.
- Background: PubMed 16842136Daskalopoulou SS, Athyros VG, Kolovou GD, Anagnostopoulou KK, Mikhailidis DP. Definitions of metabolic syndrome: Where are we now? Curr Vasc Pharmacol. 2006 Jul;4(3):185-97. doi: 10.2174/157016106777698450.
- Background: PubMed 16422124Athyros VG, Ganotakis ES, Bathianaki M, Monedas I, Goudevenos IA, Papageorgiou AA, Papathanasiou A, Kakafika AI, Mikhailidis DP, Elisaf M; MetS-Greece Collaborative Group. Awareness, treatment and control of the metabolic syndrome and its components: a multicentre Greek study. Hellenic J Cardiol. 2005 Nov-Dec;46(6):380-6.
- Background: PubMed 16092057Athyros VG, Mikhailidis DP, Papageorgiou AA, Didangelos TP, Peletidou A, Kleta D, Karagiannis A, Kakafika AI, Tziomalos K, Elisaf M. Targeting vascular risk in patients with metabolic syndrome but without diabetes. Metabolism. 2005 Aug;54(8):1065-74. doi: 10.1016/j.metabol.2005.03.010.
- Derived from this study: PubMed 21714711Athyros VG, Karagiannis A, Ganotakis ES, Paletas K, Nicolaou V, Bacharoudis G, Tziomalos K, Alexandrides T, Liberopoulos EN, Mikhailidis DP; Assessing The Treatment Effect in Metabolic syndrome without Perceptible diabeTes (ATTEMPT) Collaborative Group. Association between the changes in renal function and serum uric acid levels during multifactorial intervention and clinical outcome in patients with metabolic syndrome. A post hoc analysis of the ATTEMPT study. Curr Med Res Opin. 2011 Aug;27(8):1659-68. doi: 10.1185/03007995.2011.595782. Epub 2011 Jun 30.
- Derived from this study: PubMed 21476961Athyros VG, Ganotakis E, Kolovou GD, Nicolaou V, Achimastos A, Bilianou E, Alexandrides T, Karagiannis A, Paletas K, Liberopoulos EN, Tziomalos K, Petridis D, Kakafika A, Elisaf MS, Mikhailidis DP; Assessing The Treatment Effect in Metabolic Syndrome Without Perceptible Diabetes (ATTEMPT) Collaborative. Assessing the treatment effect in metabolic syndrome without perceptible diabetes (ATTEMPT): a prospective-randomized study in middle aged men and women. Curr Vasc Pharmacol. 2011 Nov;9(6):647-57. doi: 10.2174/157016111797484080.
- Derived from this study: PubMed 20034959Chimonas T, Athyros VG, Ganotakis E, Nicolaou V, Panagiotakos DB, Mikhailidis DP, Elisaf M; Assessing the Treatment Effect in Metabolic Syndrome Without Perceptible diabeTes (ATTEMPT) Collaborative Group. Cardiovascular risk factors and estimated 10-year risk of fatal cardiovascular events using various equations in Greeks with metabolic syndrome. Angiology. 2010 Feb-Mar;61(1):49-57. doi: 10.1177/0003319709351873.
- PMID: 21476961-Assessing The Treatment Effect in Metabolic Syndrome without Perceptible Diabetes (ATTEMPT): A Prospective-Randomized Study in Middle Aged Men and Women.Link provided by the sponsor.
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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.
Vasilios G Athyros, MD study chair
Clinical Trials Chair of Hellenic Atherosclerosis Society
Moses - Elisaf, MD study director
Clinical Trials Director of Hellenic Atherosclerosis Society
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 Metabolic Syndrome, run by Hellenic Atherosclerosis Society at 1 site in Greece.
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 4 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 27 Jun 2011. 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 Greece. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00416741, which also lists 7 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 27 Jun 2011.