NCT04611412

Brief Summary

to determine the risk factors for developing obesity in children with exogenous-constitutional obesity and arterial hypertension, according to the theories of early programming of metabolism

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

October 11, 2020

Last Update Submit

October 26, 2020

Conditions

Keywords

Metabolic Syndromechildrenobesity

Outcome Measures

Primary Outcomes (1)

  • Risk factors of metabolic syndrome

    A retrospective, cohort study of 55 children aged 12 to 18 years with exogenous constitutional obesity will be conducted Children with exogenous-constitutional obesity were divided by the presence of abdominal (visceral) obesity and the presence of hypertension. Parents will be interviewed and medical records (forms 003/y and 112) of children with exogenous constitutional obesity will be analyzed. Also, on the basis of a specially developed questionnaire, children with exogenous constitutional obesity were surveyed. When conducting a survey of children and their parents, the following factors will be of particular importance: heredity, pregnancy, weight and body length at birth, the nature of nutrition in the first two years of life, eating habits, and physical activity.

    up to 36 months

Study Arms (2)

1 group

Group I consisted of 17 people (16.83%) with a uniform type of obesity

Other: Risk Factors

2 group

Group II included 38 children with AO, and 20 of them had normal BLOOD pressure

Other: Risk Factors

Interventions

BMI in children and adolescents was compared with percentile charts developed by who for children from 5 to 19 years of age (WHO Growth Reference, 2007). Body mass index was defined as the ratio of body weight (in kg) to body length in the supine position or height in the standing position (m2).

1 group2 group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

the cohort study will include 55 children aged 12 to 18 with exogenous constitutional obesity

You may qualify if:

  • SDS (standart deviation score) of body mass index (BMI) ranging from +2.0 to +3.0

You may not qualify if:

  • secondary obesity and overweight genetic syndromes,
  • refusal of the child and/or parents to be examined

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samarkand State Medical Institute

Samarkand, 140100, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Metabolic SyndromeObesity

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2020

First Posted

November 2, 2020

Study Start

December 15, 2020

Primary Completion

December 30, 2023

Study Completion

January 2, 2024

Last Updated

November 2, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Study participants will perform all types of medical and diagnostic activities

Locations