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Complications in Hypertension and Obesity

This study is currently recruiting participants.
Verified December 2016 by Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552292
First Posted: November 1, 2007
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
  Purpose
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.

Condition
Metabolic Syndrome Hypertension Obesity Dyslipidemia Hyperglycemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Investigation of Cardiovascular Complications in Arterial Hypertension and Obesity

Resource links provided by NLM:


Further study details as provided by Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health:

Primary Outcome Measures:
  • cardiovascular complications [ Time Frame: 2007-2017 ]

Secondary Outcome Measures:
  • diabetes mellitus [ Time Frame: 2007-2017 ]

Biospecimen Retention:   Samples With DNA
Blood, urine, serum

Estimated Enrollment: 30000
Study Start Date: December 2007
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Age and sex-matched sample of subjects older 18 age
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Associated clinical conditions (stroke, TIA, MI, heart failure, renal disease, diabetes mellitus)
  • Severe concomitant diseases affecting outcome
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552292


Contacts
Contact: Alexandra O Conrady, MD, PhD +7812-70255-71 ahleague@mail.ru
Contact: Elena I Baranova, professor 346-9082 ext +7812 eibaranova@yahoo.com

Locations
Russian Federation
Almazov Federal Center of Heart, Blood and Endocrinology Recruiting
St.Petersburg, Russian Federation, 194156
Contact: Oxana P Rotari, MD    7-812-7025556    rotariox@mail.ru   
Principal Investigator: Oxana Rotari, MD         
Sponsors and Collaborators
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Investigators
Study Director: Eugene V Shlyakhto Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
  More Information

Responsible Party: Conrady Alexandra, professor, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
ClinicalTrials.gov Identifier: NCT00552292     History of Changes
Other Study ID Numbers: 25/1
First Submitted: October 31, 2007
First Posted: November 1, 2007
Last Update Posted: December 6, 2016
Last Verified: December 2016

Keywords provided by Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health:
metabolic syndrome
hypertension
obesity
dyslipidemia
hyperglycemia
cardiovascular complications

Additional relevant MeSH terms:
Hypertension
Obesity
Metabolic Syndrome X
Dyslipidemias
Hyperglycemia
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders