- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04680702
Metabolic Syndrome and Sims Score
Evaluation Of siMS Score As Amarker Of Metabolic Syndrome In Children With Simple Obesity
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).
Study Overview
Status
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Assiut, Egypt
- Recruiting
- Assuit Univesrity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Metabolic Syndrome and Sims Score
|
Evaluation Of siMS Score As Amarker Of Metabolic Syndrome In Children With Simple Obesity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
sims score as screening method of metabolic syndrome in pediatric in one year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: noha gamal, professor, Director
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- siMS SCORE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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