NCT00416741

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

5.9 years

First QC Date

December 27, 2006

Last Update Submit

June 23, 2011

Conditions

Keywords

Metabolic SyndromeObesityHyperlipidemiaHigh blood pressureDiabetes

Study Arms (2)

1 Usual Care-Lifestyle counseling

Metabolic syndrome

Behavioral: Implementation of guidelines

2 Intensive care-Lifestyle counseling

Metabolic Syndrome Implementation of guidelines

Behavioral: Implementation of guidelines

Interventions

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

1 Usual Care-Lifestyle counseling2 Intensive care-Lifestyle counseling

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Lactation
  • Malignancies with small life expectancy
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hellenic Atherosclerosis Society

Thessaloniki, Thessaloniki, 55132, Greece

Location

Related Publications (7)

  • 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.

    PMID: 16854482BACKGROUND
  • 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.

    PMID: 16842136BACKGROUND
  • 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.

    PMID: 16422124BACKGROUND
  • 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.

    PMID: 16092057BACKGROUND
  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Metabolic SyndromeObesityHyperlipidemiasHypertensionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism DisordersVascular DiseasesCardiovascular DiseasesEndocrine System Diseases

Study Officials

  • Vasilios G Athyros, MD

    Clinical Trials Chair of Hellenic Atherosclerosis Society

    STUDY CHAIR
  • Moses - Elisaf, MD

    Clinical Trials Director of Hellenic Atherosclerosis Society

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Start

February 1, 2005

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations