Assessing The Treatment Effect in Metabolic Syndrome Without Perceptible diabeTes (ATTEMPT)

NCT ID: NCT00416741

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2011-02-28

Brief Summary

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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

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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

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Metabolic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 Usual Care-Lifestyle counseling

Metabolic syndrome

Implementation of guidelines

Intervention Type BEHAVIORAL

Attaining targets for LDL cholesterol, arterial blood pressure, fasting \[plasma flucose

2 Intensive care-Lifestyle counseling

Metabolic Syndrome Implementation of guidelines

Implementation of guidelines

Intervention Type BEHAVIORAL

Attaining targets for LDL cholesterol, arterial blood pressure, fasting \[plasma flucose

Interventions

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Implementation of guidelines

Attaining targets for LDL cholesterol, arterial blood pressure, fasting \[plasma flucose

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Metabolic Syndrome (NCEP ATP III Definition modified to AHA/NHLBI definition)

Exclusion Criteria

* Pregnancy
* Lactation
* Malignancies with small life expectancy
* Unwillingness to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hellenic Atherosclerosis Society

OTHER

Sponsor Role lead

Responsible Party

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HellenicAS

Principal Investigators

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Vasilios G Athyros, MD

Role: STUDY_CHAIR

Clinical Trials Chair of Hellenic Atherosclerosis Society

Moses - Elisaf, MD

Role: STUDY_DIRECTOR

Clinical Trials Director of Hellenic Atherosclerosis Society

Locations

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Hellenic Atherosclerosis Society

Thessaloniki, Thessaloniki, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 16854482 (View on PubMed)

Daskalopoulou 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.

Reference Type BACKGROUND
PMID: 16842136 (View on PubMed)

Athyros 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.

Reference Type BACKGROUND
PMID: 16422124 (View on PubMed)

Athyros 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.

Reference Type BACKGROUND
PMID: 16092057 (View on PubMed)

Athyros 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.

Reference Type DERIVED
PMID: 21714711 (View on PubMed)

Athyros 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.

Reference Type DERIVED
PMID: 21476961 (View on PubMed)

Chimonas 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.

Reference Type DERIVED
PMID: 20034959 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed?term=athyros

PMID: 21476961-Assessing The Treatment Effect in Metabolic Syndrome without Perceptible Diabetes (ATTEMPT): A Prospective-Randomized Study in Middle Aged Men and Women.

Other Identifiers

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HAS-01-231206

Identifier Type: -

Identifier Source: org_study_id

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