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NCT04680702 Clinical Trial

Metabolic Syndrome and Sims Score

Metabolic Syndrome , Sims Score and Pediatrics Clinical Trial

Official title:
Evaluation Of siMS Score As Amarker Of Metabolic Syndrome In Children With Simple Obesity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04680702
Other study ID # siMS SCORE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2020
Est. completion date December 1, 2022

Study information
Verified date December 2020
Source Assiut University
Contact basma sayed, master
Phone 01010604622
Email basmasayedib@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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), 1. Central Obesity (WC): WC ≥ 90th percentile . 2. High BP (mmHg) : Systolic or diastolic DBP≥ 90% for age, sex, height 3. High Triglycerides (mg/dL) : TG ≥ 110 mg/dL (≥1.24 mmol/L) . 4. HDL ≤ 40 mg/dL(<1.03 mmol/L). 5. 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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 1, 2022
Est. primary completion date December 29, 2020
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility 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 (ß-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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Sims Score
Evaluation Of siMS Score As Amarker Of Metabolic Syndrome In Children With Simple Obesity

Locations
Country Name City State
Egypt Assuit Univesrity Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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