Pre-DiabetesNCT06117358
Detection of Pre-Diabetes in Overweight and Obese Children
An observational study of Pre-Diabetes, run by Assiut University.
Trial summary
Descriptive cross section study To detect prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pre-Diabetes
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 31 Mar 2025
- 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 10 to 18 years
- All sexes
- Child, Adult
Study population: • obese and overweight children and adolescents in Assiut governorate aged between (10-18) years.
Who may be able to join
- Both sexes , aged (10-18) years.
- Body mass index calculated as weight in Kg/(height in meters)2 :
- Over weight > 85% percentile
- Obese > 95% percentile " On Egyptian growth chart "
Who cannot join
- • Children and adolescents with type 2 diabetes mellitus.
- Children and adolescents with drug history affecting blood glucose level as corticosteroids.
- Children and adolescents with any condition affecting blood glucose level as Cushing disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection of Pre-Diabetes in Overweight and Obese Children and Adolescents in Assiut Governorate
Descriptive cross section study To detect prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors.
Read the detailed description
Childhood obesity has reached epidemic levels in developed as well as in developing countries, Overweight and obesity in childhood have significant impact on both physical and psychological health.
Childhood obesity has been linked to numerous medical conditions. These conditions include : fatty liver disease, sleep apnea, Type 2 diabetes, asthma, cardiovascular disease, high cholesterol, cholelithiasis (gallstones), glucose intolerance and insulin resistance, etc.
Obesity is associated with Prediabetes , a significant risk factor for development of type 2 diabetes mellitus T2DM and its accompanying complications.
In some populations, type 2 diabetes is now the dominant form of diabetes in children and adolescents.
Prediabetes is defined by a fasting glucose level of 100 to 125 mg/dL , glycated hemoglobin level (HbA1C) of 5.7% to 6.4% , or a glucose level of 140 to 199 mg/dL measured 2 hours after a 75-g oral glucose load. approximately 10% of people with prediabetes progress to having diabetes each year.
The vast majority of pediatric cases occur after age 10, with the peak age for presentation occurring at mid-puberty (approximately age 14 years).
The ADA recommends screening for type 2 diabetes in children after onset of puberty or age 10 years who are overweight (BMI ≥85th percentile) or obese (BMI ≥95th percentile) and have one or more additional risk factors for diabetes.
One report in JAMA Pediatrics found that nearly one in three adolescents and teens has prediabetes and the rate among 12 to 19 year-olds more than doubled between 1999-2002 and 2015-2018, jumping from 12 percent to 28 percent.
However , no enough data are available regarding prevalence and risk factors of prediabetes in overweight and obese youth particularly in our locality.
- Conditions
- Pre-Diabetes
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Descriptive cross section study
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Pre-Diabetes in Overweight and Obese children and adolescents in Assiut governorate
determine the prevalence of prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors through many investigations as HbA1c , Fasting blood glucose level , Lipid profile in 150 obese children.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-DiabetesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Bakr Gaber, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117358
- Sponsor's protocol ID
- Detection of Pre-Diabetes
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Pre-Diabetes in Overweight and Obese Children and Adolescents in Assiut Governorate
- ClinicalTrials.gov ID
- NCT06117358
- Acronym / sponsor ID
- Detection of Pre-Diabetes
- Conditions
- Pre-Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 7 Nov 2023 (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.
Descriptive cross section study To detect prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors.
Detailed description
Childhood obesity has reached epidemic levels in developed as well as in developing countries, Overweight and obesity in childhood have significant impact on both physical and psychological health.
Childhood obesity has been linked to numerous medical conditions. These conditions include : fatty liver disease, sleep apnea, Type 2 diabetes, asthma, cardiovascular disease, high cholesterol, cholelithiasis (gallstones), glucose intolerance and insulin resistance, etc.
Obesity is associated with Prediabetes , a significant risk factor for development of type 2 diabetes mellitus T2DM and its accompanying complications.
In some populations, type 2 diabetes is now the dominant form of diabetes in children and adolescents.
Prediabetes is defined by a fasting glucose level of 100 to 125 mg/dL , glycated hemoglobin level (HbA1C) of 5.7% to 6.4% , or a glucose level of 140 to 199 mg/dL measured 2 hours after a 75-g oral glucose load. approximately 10% of people with prediabetes progress to having diabetes each year.
The vast majority of pediatric cases occur after age 10, with the peak age for presentation occurring at mid-puberty (approximately age 14 years).
The ADA recommends screening for type 2 diabetes in children after onset of puberty or age 10 years who are overweight (BMI ≥85th percentile) or obese (BMI ≥95th percentile) and have one or more additional risk factors for diabetes.
One report in JAMA Pediatrics found that nearly one in three adolescents and teens has prediabetes and the rate among 12 to 19 year-olds more than doubled between 1999-2002 and 2015-2018, jumping from 12 percent to 28 percent.
However , no enough data are available regarding prevalence and risk factors of prediabetes in overweight and obese youth particularly in our locality.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- • obese and overweight children and adolescents in Assiut governorate aged between (10-18) years.
Key inclusion criteria (4 listed)
- Both sexes , aged (10-18) years.
- Body mass index calculated as weight in Kg/(height in meters)2 :
Key exclusion criteria (3 listed)
- • Children and adolescents with type 2 diabetes mellitus.
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 |
|---|---|---|
| Descriptive cross section study | Other | – |
Primary outcome
Prevalence of Pre-Diabetes in Overweight and Obese children and adolescents in Assiut governorate
Time frame: Baseline
determine the prevalence of prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors through many investigations as HbA1c , Fasting blood glucose level , Lipid profile in 150 obese children.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Diabetes, run by Assiut University.
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 4 inclusion and 3 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mahmouud Bakr (+201067094097, mahmoudbakr423@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Pre-Diabetes in Overweight and Obese children and adolescents in Assiut governorate (time frame: Baseline). 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 7 Nov 2023.