NCT01268696

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 22, 2011

Status Verified

December 1, 2010

Enrollment Period

8 months

First QC Date

December 28, 2010

Last Update Submit

July 20, 2011

Conditions

Metabolic Syndrome

Keywords

diabetesobesityhypertensiondyslipidemia

Study Arms (2)

control group

healthy volunteers

Metabolic group

Patients with metabolic syndrome

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with metabolic syndrome

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of medical biotechnology Medical University of Lodz

Lodz, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

the blood samples taken into EDTA

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusObesityHypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesLipid Metabolism Disorders

Study Officials

  • Tadeusz Pietrucha, prof.

    Department of medical biotechnology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2010

First Posted

December 31, 2010

Study Start

December 1, 2010

Primary Completion

August 1, 2011

Study Completion

January 1, 2015

Last Updated

July 22, 2011

Record last verified: 2010-12

Locations

PL(1)