Complications in Hypertension and Obesity | NCT00552292

Studies
Complications in Hypertension and Obesity

NCT00552292

Sponsor

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

Status

Unknown status

Last Update Posted

Dec 6, 2016Estimated

Enrollment

30,000Estimated

Phase

Not provided

Conditions

Metabolic Syndrome
Hypertension
Obesity
Dyslipidemia
Hyperglycemia

Interventions

Not provided

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

May 2017Estimated

Completion Date

May 2017Estimated

First Submitted Date

Oct 31, 2007

First Submission Date that Met QC Criteria

Oct 31, 2007

First Posted Date

Nov 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2016

Last Update Posted Date

Dec 6, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Conrady Alexandra, professor, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30,000Estimated

Measure	Description	Time Frame
cardiovascular complications		2007-2017

Measure	Description	Time Frame
diabetes mellitus		2007-2017

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Age and sex-matched sample of subjects older 18 age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexandra O Conrady, MD, PhD	Contact	+7812-70255-71		ahleague@mail.ru
Elena I Baranova, professor	Contact	346-9082	+7812	eibaranova@yahoo.com

Overall Officials

Name	Affiliation	Role
Eugene V Shlyakhto	Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Almazov Federal Center of Heart, Blood and Endocrinology	Recruiting	Saint Petersburg		194156	Russia

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D006973	Hypertension
D009765	Obesity
D050171	Dyslipidemias
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided