Metabolic SyndromeNCT04611412
Determination of Risk Factors for the Development of Obesity and Hypertension in Children According to Perinatal Programming of Metabolism
An observational study of Metabolic Syndrome, run by Samarkand State Medical Institute at 1 site in Uzbekistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Risk Factors
- How many people
- 55 participants
- Where
- 1 siteUzbekistan
- Study dates
- 15 Dec 2020to 2 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Child, Adult
Study population: the cohort study will include 55 children aged 12 to 18 with exogenous constitutional obesity
Who may be able to join
- SDS (standart deviation score) of body mass index (BMI) ranging from +2.0 to +3.0
Who cannot join
- secondary obesity and overweight genetic syndromes,
- refusal of the child and/or parents to be examined
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site, 1 recruiting
- Recruiting
Samarkand State Medical Institute
Samarkand, 140100
Lilya M Garifulina, PhD, +998915497971, ms.garifulina77@mail.ru
About this study
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
Read the detailed description
A retrospective cohort study of 55 children aged 12 to 18 years (average 14.60±0.24 years) with exogenous-constitutional obesity was conducted, with 24 girls (43.6%) and 31 (56.4%) boys. Children were identified during dispensary examinations in family clinics in Samarkand in the period 2018-2019. All the examined children belonged to the Uzbek population.
- Conditions
- Metabolic Syndrome
- Being tested
- Risk Factors
- Keywords
- Metabolic Syndrome, children, obesity
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk FactorsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 1 group | Group I consisted of 17 people (16.83%) with a uniform type of obesity Receives: Other: Risk Factors | |
| 2 group | Group II included 38 children with AO, and 20 of them had normal BLOOD pressure Receives: Other: Risk Factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start15 Dec 2020 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion2 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samarkand State Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611412
- Sponsor's protocol ID
- Project #4
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study participants will perform all types of medical and diagnostic activities
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Risk Factors for the Development of Obesity and Hypertension in Children According to Perinatal Programming of Metabolism
- ClinicalTrials.gov ID
- NCT04611412
- Acronym / sponsor ID
- Project #4
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, children, obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Samarkand State Medical InstituteUniversity, hospital or other
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 2 Jan 2024 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A retrospective cohort study of 55 children aged 12 to 18 years (average 14.60±0.24 years) with exogenous-constitutional obesity was conducted, with 24 girls (43.6%) and 31 (56.4%) boys. Children were identified during dispensary examinations in family clinics in Samarkand in the period 2018-2019. All the examined children belonged to the Uzbek population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 group | – | Other: Risk FactorsGroup I consisted of 17 people (16.83%) with a uniform type of obesity |
| 2 group | – | Other: Risk FactorsGroup II included 38 children with AO, and 20 of them had normal BLOOD pressure |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- the cohort study will include 55 children aged 12 to 18 with exogenous constitutional obesity
Key inclusion criteria (1 listed)
- SDS (standart deviation score) of body mass index (BMI) ranging from +2.0 to +3.0
Key exclusion criteria (2 listed)
- secondary obesity and overweight genetic syndromes,
- refusal of the child and/or parents to be examined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk FactorsBMI 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). | Other | 1 group, 2 group |
Primary outcome
Risk factors of metabolic syndrome
Time frame: up to 36 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: No. Study participants will perform all types of medical and diagnostic activities
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Samarkand State Medical Institute at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors of metabolic syndrome (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.