Metabolic Syndrome and Sims Score

December 28, 2020 updated by: BASMA SAYED, Assiut University

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

Unknown

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),

  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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt
        • Recruiting
        • Assuit Univesrity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: noha gamal, professor, Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Anticipated)

December 29, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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