NCT03469115

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.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

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

March 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

March 12, 2018

Last Update Submit

March 12, 2018

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Alpha defensin level

    Alpha defensin level above 12ng/microliter

    2 hours

Study Arms (2)

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

Serum bloodDIAGNOSTIC_TEST

Serum blood test for laboratory analysis to determine level of alpha defensin

BMI above 95%BMI below 3%

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eias Kassem, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eias Kassem, MD

CONTACT

972-50-6246882eiask@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Adolescents aged 13-17 will be divided into two groups according to BMI (body mass index)
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 19, 2018

Study Start

March 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

March 19, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)