Complications in Hypertension and Obesity

Obesity Clinical Trial

Official title:

National Investigation of Cardiovascular Complications in Arterial Hypertension and Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00552292
• Other study ID #: 25/1
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2007
• Last updated: December 5, 2016
• Start date: December 2007
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: Alexandra O Conrady, MD, PhD
• Phone: +7812-70255-71
• Email: ahleague[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hyperglycemia
• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Locations

Country	Name	City	State
Russian Federation	Almazov Federal Center of Heart, Blood and Endocrinology	St.Petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular complications		2007-2017	No
Secondary	diabetes mellitus		2007-2017	No