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

Metabolic Syndrome Clinical Trial

— ATTEMPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416741
• Other study ID #: HAS-01-231206
• Status: Completed
• Phase: Phase 4
• First received: December 27, 2006
• Last updated: June 23, 2011
• Start date: February 2005
• Est. completion date: February 2011

Study information

• Verified date: June 2011
• Source: Hellenic Atherosclerosis Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• Implementation of guidelines
Attaining targets for LDL cholesterol, arterial blood pressure, fasting [plasma flucose

Locations

Country	Name	City	State
Greece	Hellenic Atherosclerosis Society	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Atherosclerosis Society

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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. — View Citation

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. Epub 2006 Jul 18. — View Citation

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. — View Citation

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. Review. — View Citation

External Links

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