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

March 12, 2018 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hille Yaffe medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BMI above 95%
Serum blood will be taken from obese youths with suspected metabolic syndrome
Diagnostic test: Serum blood
Serum blood test for laboratory analysis to determine level of alpha defensin
Active Comparator: BMI below 3%
Serum blood will be taken from slim youths
Diagnostic test: Serum blood
Serum blood test for laboratory analysis to determine level of alpha defensin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-15-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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