New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin
Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03469115
Collaborator
(none)
100
1
2
18
5.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Adolescents aged 13-17 will be divided into two groups according to BMI (body mass index)Adolescents aged 13-17 will be divided into two groups according to BMI (body mass index)
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin
Anticipated Study Start Date
:
Mar 1, 2018
Anticipated Primary Completion Date
:
Sep 1, 2019
Anticipated Study Completion Date
:
Sep 1, 2019
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Alpha defensin level [2 hours]
Alpha defensin level above 12ng/microliter
Eligibility Criteria
Criteria
Ages Eligible for Study:
13 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Youths with metabolic syndrome (BMI above 95%)
-
Youths with BMI below 3%
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hille Yaffe Medical Center | Hadera | Israel | 38100 |
Sponsors and Collaborators
- Hillel Yaffe Medical Center
Investigators
- Principal Investigator: Eias Kassem, MD, Hillel Yaffe Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT03469115
Other Study ID Numbers:
- HYMC-15-18
First Posted:
Mar 19, 2018
Last Update Posted:
Mar 19, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: