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

This study has been completed.
Sponsor:
Information provided by:
Hellenic Atherosclerosis Society
ClinicalTrials.gov Identifier:
NCT00416741
First received: December 27, 2006
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Behavioral: Implementation of guidelines
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing The Treatment Effect in Metabolic Syndrome Without Perceptible diabeTes (ATTEMPT)

Resource links provided by NLM:


Further study details as provided by Hellenic Atherosclerosis Society:

Enrollment: 2000
Study Start Date: February 2005
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Usual Care-Lifestyle counseling
Metabolic syndrome
Behavioral: Implementation of guidelines
Attaining targets for LDL cholesterol, arterial blood pressure, fasting [plasma flucose
2 Intensive care-Lifestyle counseling
Metabolic Syndrome Implementation of guidelines
Behavioral: Implementation of guidelines
Attaining targets for LDL cholesterol, arterial blood pressure, fasting [plasma flucose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416741

Locations
Greece
Hellenic Atherosclerosis Society
Thessaloniki, Greece, 55132
Sponsors and Collaborators
Hellenic Atherosclerosis Society
Investigators
Study Chair: Vasilios G Athyros, MD Clinical Trials Chair of Hellenic Atherosclerosis Society
Study Director: Moses - Elisaf, MD Clinical Trials Director of Hellenic Atherosclerosis Society
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: V.G. Athyros, MD Study Administrator, HellenicAS
ClinicalTrials.gov Identifier: NCT00416741     History of Changes
Other Study ID Numbers: HAS-01-231206
Study First Received: December 27, 2006
Last Updated: June 23, 2011
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Hellenic Atherosclerosis Society:
Metabolic Syndrome
Obesity
Hyperlipidemia
High blood pressure
Diabetes

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014