New Insights Into the Metabolic Syndrome: the Role of Alp... | NCT03469115

Studies
New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin

NCT03469115

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Mar 19, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Metabolic Syndrome

Interventions

Serum blood

Countries

Israel

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2018Estimated

Primary Completion Date

Sep 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Mar 12, 2018

First Submission Date that Met QC Criteria

Mar 12, 2018

First Posted Date

Mar 19, 2018Actual

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

Mar 12, 2018

Last Update Posted Date

Mar 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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 purpose of this study is to find out if there is a connection between a higher level of peptide alpha defensin in blood serum with the metabolic profile of adolescents aged 13-17.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMI above 95%	Active Comparator	Serum blood will be taken from obese youths with suspected metabolic syndrome	Diagnostic Test: Serum blood
BMI below 3%	Active Comparator	Serum blood will be taken from slim youths	Diagnostic Test: Serum blood

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum blood	Diagnostic Test	Serum blood test for laboratory analysis to determine level of alpha defensin	BMI above 95% BMI below 3%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alpha defensin level	Alpha defensin level above 12ng/microliter	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Youths with metabolic syndrome (BMI above 95%)
Youths with BMI below 3%

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eias Kassem, MD	Contact	972-50-6246882		eiask@hy.health.gov.il

Overall Officials

Name	Affiliation	Role
Eias Kassem, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hille Yaffe Medical Center		Hadera		38100	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided