NCT00552292

Brief Summary

The study in aimed to investigate epidemiology of risk factors in Russian Federation its prognostic value aimed on acceptance of national specific definition of metabolic syndrome and guidelines for its management.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

9.4 years

First QC Date

October 31, 2007

Last Update Submit

December 5, 2016

Conditions

Metabolic SyndromeHypertensionObesityDyslipidemiaHyperglycemia

Keywords

metabolic syndromehypertensionobesitydyslipidemiahyperglycemiacardiovascular complications

Outcome Measures

Primary Outcomes (1)

  • cardiovascular complications

    2007-2017

Secondary Outcomes (1)

  • diabetes mellitus

    2007-2017

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Age and sex-matched sample of subjects older 18 age

You may qualify if:

  • Age older 18 years
  • Signed informed consent
  • Blood pressure more than 130 and/or 85 mm Hg
  • Waist circumference more than 80 sm in females and 94 in males and/or BMI more than 25 kg/m2
  • Dyslipidemia (elevated TG and/or decreased level of HDLP or therapy for high triglyceride level)
  • Fasting glucose more than 5,6 mmol/l

You may not qualify if:

  • Associated clinical conditions (stroke, TIA, MI, heart failure, renal disease, diabetes mellitus)
  • Severe concomitant diseases affecting outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almazov Federal Center of Heart, Blood and Endocrinology

Saint Petersburg, 194156, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, serum

MeSH Terms

Conditions

Metabolic SyndromeHypertensionObesityDyslipidemiasHyperglycemia

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism Disorders

Study Officials

  • Eugene V Shlyakhto

    Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    STUDY DIRECTOR

Central Study Contacts

Alexandra O Conrady, MD, PhD

CONTACT

+7812-70255-71ahleague@mail.ru

Elena I Baranova, professor

CONTACT

346-9082eibaranova@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 1, 2007

Study Start

December 1, 2007

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

RU(1)