Metabolic Syndrome and Sims Score

NCT ID: NCT04680702

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-12-01

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),

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

Conditions

Metabolic Syndrome , Sims Score and Pediatrics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Metabolic Syndrome and Sims Score

Group Type: EXPERIMENTAL

Sims Score

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Sims Score

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

Intervention Type: DIAGNOSTIC_TEST

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).

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

BASMA SAYED

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

noha gamal, professor

Role: STUDY_DIRECTOR

Director

Locations

Assuit Univesrity

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

basma sayed, master

Role: CONTACT

Phone: 01010604622

Email: basmasayedib@gmail.com

Other Identifiers

siMS SCORE

Identifier Type: -

Identifier Source: org_study_id