- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04015726
Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India
Studie Overzicht
Toestand
Gedetailleerde beschrijving
This programme will be conducted after obtaining prior permission from the Directorate of School Education, Government of Tamil Nadu and school authorities. This study will be conducted in 22 schools in Chennai involving 2815 students of age group 12 to 18 years. Initially the study and its procedure will be explained to the principal and the teachers of the school. Request the school authority to fix a date for each standard/grade to explain about the informed consent / assent form and the study process to the students. The students will be asked to give the informed consent/assent form to their parents and asked to get their signature in the specified place. Instruction will be given to the students that their parents can call the Investigator if they have any doubts in the informed consent/assent form. After giving ample time for the informed consent process the students will be asked to give the informed consent when the research team goes to the school. The informed consent should be countersigned by the teachers to confirm the authenticity of the parent's signature. The research team gets the signature from the student in the assent form. A date is finalized with the school authority for the screening. The students are advised to come in fasting for the test. On the day of screening the student will be given a screening number. Necessary details such as personal and family information, anthropometry (height, weight, waist circumference, body fat) and blood pressure will be measured. Medical history, diet, physical activity, and sleep habits and questionnaire on awareness on diabetes will be recorded. Laboratory investigations such as fasting blood glucose, plasma insulin and lipid profile (Total Cholesterol, Triglyceride, Low-Density Lipoprotein (LDL), Very Low-Density Lipoprotein (VLDL) and High-Density Lipoprotein (HDL)) will be measured.
After the assessment, the students will be given refreshments and a few minutes of rest. The samples will be sent to the central laboratory for analyses. The reports will be distributed to the students within a week's time. Parents will be personally contacted by the research team if there is any concern in the lab report which requires medical attention.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Ambady Ramachandran, MD, PhD, DSc
- Telefoonnummer: 04422353730
- E-mail: research@ardiabetes.org
Studie Locaties
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Tamil Nadu
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Chennai, Tamil Nadu, Indië, 600008
- Werving
- India Diabetes Research Foundation
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Contact:
- Ambady Ramachandran, MD, PhD, DSc
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Hoofdonderzoeker:
- Ambady Ramachandran, MD, PhD, DSc
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Children both boys and girls between 12 - 18yrs age group
- Parents and child willing to give informed consent
- Children must be available for and willing to attend all evaluation visits
- Willingness to follow the protocol requirements as evidenced by written informed consent
Exclusion Criteria:
- Children below the age of 12 years and above the age of 18 years
- Parents or Child who is not willing to participate in the study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Ander
- Tijdsperspectieven: Dwarsdoorsnede
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Prevalence of central adiposity
Tijdsspanne: baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
baseline
|
Prevalence of dysglycemia
Tijdsspanne: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of dyslipidemia
Tijdsspanne: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of hypertension
Tijdsspanne: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of insulin resistance
Tijdsspanne: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Prevalence of overweight
Tijdsspanne: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Prevalence of obesity
Tijdsspanne: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Changes in diet habit
Tijdsspanne: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Changes in duration of physical activity
Tijdsspanne: Baseline
|
Among adolescent children in 2019 in comparison with 2006 data
|
Baseline
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Ambady Ramachandran, MD, PhD, DSc, Senior Research Officer
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IDRFARH012
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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