Metabolic Syndrome and Sims Score
Primary Purpose
Metabolic Syndrome , Sims Score and Pediatrics
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sims Score
Sponsored by
About this trial
This is an interventional screening trial for Metabolic Syndrome , Sims Score and Pediatrics
Eligibility Criteria
Inclusion Criteria:
- All obese patients aged from 7 to 17 years old.
Exclusion Criteria:
All obesechildren
- With endocrial and syndromatic obesity, (Endocrinal disease as hypothyroidism and Cushing's syndrome etc, syndromic obesity asPrader-Willi syndrome ,Alstrom-Hallgren syndrome, Bardet-Biedl syndrome, Beckwith-Wiedemansyndrome,etc…….)
- Children on medications that affect lipid profile that include (β-Blockers ,Amiodarone ,Loop diuretics, Thiazide diuretics (high dose) ,Sodium-glucose co-transporter 2 (SGLT2) inhibitors ,Steroid Hormones/Anabolic Steroids, Antiviral Therapy ,Immunosuppressants ,Centrally Acting Medications as Anticonvulsants).
Sites / Locations
- Assuit UnivesrityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metabolic Syndrome and Sims Score
Arm Description
Outcomes
Primary Outcome Measures
sims score as screening method of metabolic syndrome in pediatric in one year
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04680702
Brief Title
Metabolic Syndrome and Sims Score
Official Title
Evaluation Of siMS Score As Amarker Of Metabolic Syndrome In Children With Simple Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 29, 2020 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
SiMSscore was used as a simple and accurate method for Quantifying Metabolic Syndrome in adults , Developed siMS score was calculated using formula: siMS score = 2*Waist/Height + Gly/5.6 + Tg/1.7 + TAsystolic/130-HDL/1.02 or 1.28 (for male or female subjects, respectively),However studies on siMSscor in pediatric was done .
PsiMSscore(pediatric sims score) calculated using formula: (2xWaist/Height) + (Glucose(mmol/l)/5.6) + (triglycerides(mmol/l)/1.7) + (Systolic BP/130)-(HDL(mmol/l)/1.02(Soldatovic etal;2016).
Detailed Description
Metabolic Syndrome (MetS) is defined as a cluster of cardio metabolic risk factors that include central obesity low levels of high-density lipoprotein-cholesterol (HDL-C), hypertriglyceridemia, hypertension, and hyperglycaemia. Metabolic changes in childhood track into adulthood, predisposing these individuals to type 2 diabetes, and cardiovascular diseases.
The underlying prevalence of MetS in adolescents depends on the set of MetScri:eria used, with overall ranges in the US from 1.2%-9.8% using modified ATP-III criteria (Adult Treatment PanelII) to 4.5%-8.4% using the IDF adolescent criteria . Assessments among school-aged children and early adolescents islower (0.2%-1.2%) which is likely because of the strong effects of puberty on insulin resistance.
There is no consensus regarding the diagnosis of metabolic syndrome in children and adolescents. It is evident that each component of the syndrome must be identified as early as possible in order to prevent definitive lesion Pediatric and adolescent metabolic syndrome (MetS) criteria adapted from the National Cholesterol Education Program Adult Treatment Panel III (ATP lll),
Central Obesity (WC): WC ≥ 90th percentile .
High BP (mmHg) : Systolic or diastolic DBP≥ 90% for age, sex, height
High Triglycerides (mg/dL) : TG ≥ 110 mg/dL (≥1.24 mmol/L) .
HDL ≤ 40 mg/dL(<1.03 mmol/L).
High Fasting Glucose :≥100 mg/dL (5.6 mmol/L) or known T2DM. Individuals need to have at least three abnormalities in MetS components to be classified as havingMetS SiMSscore was used as a simple and accurate method for Quantifying Metabolic Syndrome in adults , Developed siMS score was calculated using formula: siMS score = 2*Waist/Height + Gly/5.6 + Tg/1.7 + TAsystolic/130-HDL/1.02 or 1.28 (for male or female subjects, respectively),However studies on siMSscor in pediatric was done .
PsiMSscore(pediatric sims score) calculated using formula: (2xWaist/Height) + (Glucose(mmol/l)/5.6) + (triglycerides(mmol/l)/1.7) + (Systolic BP/130)-(HDL(mmol/l)/1.02
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome , Sims Score and Pediatrics
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metabolic Syndrome and Sims Score
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Sims Score
Intervention Description
Evaluation Of siMS Score As Amarker Of Metabolic Syndrome In Children With Simple Obesity
Primary Outcome Measure Information:
Title
sims score as screening method of metabolic syndrome in pediatric in one year
Time Frame
sims score as screening method of metabolic syndrome in pediatric in one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All obese patients aged from 7 to 17 years old.
Exclusion Criteria:
All obesechildren
With endocrial and syndromatic obesity, (Endocrinal disease as hypothyroidism and Cushing's syndrome etc, syndromic obesity asPrader-Willi syndrome ,Alstrom-Hallgren syndrome, Bardet-Biedl syndrome, Beckwith-Wiedemansyndrome,etc…….)
Children on medications that affect lipid profile that include (β-Blockers ,Amiodarone ,Loop diuretics, Thiazide diuretics (high dose) ,Sodium-glucose co-transporter 2 (SGLT2) inhibitors ,Steroid Hormones/Anabolic Steroids, Antiviral Therapy ,Immunosuppressants ,Centrally Acting Medications as Anticonvulsants).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
basma sayed, master
Phone
01010604622
Email
basmasayedib@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
noha gamal, professor
Organizational Affiliation
Director
Official's Role
Study Director
Facility Information:
Facility Name
Assuit Univesrity
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
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