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Genetic Assessment of the Patients With Metabolic Syndrome (GENMetS)

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ClinicalTrials.gov Identifier: NCT01268696
Recruitment Status : Unknown
Verified December 2010 by Medical Universtity of Lodz.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2010
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:
Medical Universtity of Lodz

Tracking Information
First Submitted Date December 28, 2010
First Posted Date December 31, 2010
Last Update Posted Date July 22, 2011
Study Start Date December 2010
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01268696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic Assessment of the Patients With Metabolic Syndrome
Official Title Genetic Assessment of the Patients With Metabolic Syndrome in Polish Population
Brief Summary

Metabolic syndrome is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes. The exact mechanisms of the complex pathways of metabolic syndrome are not yet completely known. The pathophysiology is extremely complex and has been only partially elucidated. Most patients are older, obese, sedentary, and have a degree of insulin resistance. Stress can also be a contributing factor. The most important factors are:

weight, genetics, aging, sedentary lifestyle,excess caloric intake. In our study we will assess the role of some polymorphisms in the pathology of metabolic syndrome.

Detailed Description

Eligibility criteria to the study:

  • patients with metabolic syndrome
  • with written consent
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
the blood samples taken into EDTA
Sampling Method Probability Sample
Study Population Patients with metabolic syndrome
Condition Metabolic Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • control group
    healthy volunteers
  • Metabolic group
    Patients with metabolic syndrome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December¬†30,¬†2010)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2015
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with metabolic syndrome according to IDF,AHA and NHLBI 2009

Exclusion Criteria:

  • diabetes type 1
  • cancer
  • not consent
  • steroid therapy
  • alcohol or drug abuse
  • chronic inflammatory disease
  • pregnancy or lactation
  • severe hypothyroidism
  • immunosuppressive treatment
  • operation or severe injury during the last month
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01268696
Other Study ID Numbers RNN/202/10/KE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Department of Medical Biotechnology, Medical University of Lodz
Study Sponsor Medical Universtity of Lodz
Collaborators Not Provided
Investigators
Study Chair: Tadeusz Pietrucha, prof. Department of medical biotechnology
PRS Account Medical Universtity of Lodz
Verification Date December 2010