Genetic Assessment of the Patients With Metabolic Syndrome | NCT01268696

Studies
Genetic Assessment of the Patients With Metabolic Syndrome

NCT01268696

Sponsor

Medical University of Lodz

Status

Unknown status

Last Update Posted

Jul 22, 2011Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Metabolic Syndrome

Interventions

Not provided

Countries

Poland

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 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Aug 2011Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Dec 28, 2010

First Submission Date that Met QC Criteria

Dec 30, 2010

First Posted Date

Dec 31, 2010Estimated

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

Jul 20, 2011

Last Update Posted Date

Jul 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group		healthy volunteers
Metabolic group		Patients with metabolic syndrome

Interventions

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with metabolic syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tadeusz Pietrucha, prof.	Department of medical biotechnology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of medical biotechnology Medical University of Lodz		Lodz			Poland

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D003920	Diabetes Mellitus
D009765	Obesity
D006973	Hypertension
D050171	Dyslipidemias

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided