Back to resultsNew Insights Into the Metabolic Syndrome: the Role of Alpha Defensin
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Serum blood
Sponsored by
About this trial
This is an interventional screening trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Youths with metabolic syndrome (BMI above 95%)
- Youths with BMI below 3%
Exclusion Criteria:
-
Sites / Locations
- Hille Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BMI above 95%
BMI below 3%
Arm Description
Serum blood will be taken from obese youths with suspected metabolic syndrome
Serum blood will be taken from slim youths
Outcomes
Primary Outcome Measures
Alpha defensin level
Alpha defensin level above 12ng/microliter
Secondary Outcome Measures
Full Information
NCT ID
NCT03469115
First Posted
March 12, 2018
Last Updated
March 12, 2018
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03469115
Brief Title
New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin
Official Title
New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adolescents aged 13-17 will be divided into two groups according to BMI (body mass index)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BMI above 95%
Arm Type
Active Comparator
Arm Description
Serum blood will be taken from obese youths with suspected metabolic syndrome
Arm Title
BMI below 3%
Arm Type
Active Comparator
Arm Description
Serum blood will be taken from slim youths
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum blood
Intervention Description
Serum blood test for laboratory analysis to determine level of alpha defensin
Primary Outcome Measure Information:
Title
Alpha defensin level
Description
Alpha defensin level above 12ng/microliter
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Youths with metabolic syndrome (BMI above 95%)
Youths with BMI below 3%
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eias Kassem, MD
Phone
972-50-6246882
Email
eiask@hy.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eias Kassem, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hille Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eias Kassem, MD
Email
eiask@hy.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin
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