Metabolic SyndromeNCT00552292
Complications in Hypertension and Obesity
An observational study of Metabolic Syndrome and Hypertension, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Metabolic Syndrome, Hypertension, Obesity
- How many people
- 30,000 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2007to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age and sex-matched sample of subjects older 18 age
Who may be able to join
- 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
Who cannot join
- Associated clinical conditions (stroke, TIA, MI, heart failure, renal disease, diabetes mellitus)
- Severe concomitant diseases affecting outcome
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Almazov Federal Center of Heart, Blood and Endocrinology
Saint Petersburg, 194156
Oxana P Rotari, MD, 7-812-7025556, rotariox@mail.ru
Oxana Rotari, MD
About this study
Official title: National Investigation of Cardiovascular Complications in Arterial Hypertension and Obesity
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.
- Conditions
- Metabolic Syndrome, Hypertension, Obesity, Dyslipidemia, Hyperglycemia
- Keywords
- metabolic syndrome, hypertension, obesity, dyslipidemia, hyperglycemia, cardiovascular complications
- Medical subject headings
- Metabolic Syndrome, Hypertension, Obesity, Dyslipidemias, Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular complications
Measured: 2007-2017
Secondary outcomes (1)
diabetes mellitus
Measured: 2007-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Investigators
- Eugene V Shlyakhto, Study director, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552292
- Sponsor's protocol ID
- 25/1
- Status last verified
- Dec 2016
- First submitted
- 31 Oct 2007
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Investigation of Cardiovascular Complications in Arterial Hypertension and Obesity
- ClinicalTrials.gov ID
- NCT00552292
- Acronym / sponsor ID
- 25/1
- Conditions
- Metabolic Syndrome, Hypertension, Obesity, Dyslipidemia, Hyperglycemia
- Keywords
- metabolic syndrome, hypertension, obesity, dyslipidemia, hyperglycemia, cardiovascular complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age and sex-matched sample of subjects older 18 age
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Associated clinical conditions (stroke, TIA, MI, heart failure, renal disease, diabetes mellitus)
- Severe concomitant diseases affecting outcome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiovascular complications
Time frame: 2007-2017
1 secondary outcome
diabetes mellitus
Time frame: 2007-2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene V Shlyakhto study director
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Hypertension, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra O Conrady, MD, PhD (+7812-70255-71, ahleague@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular complications (time frame: 2007-2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.