Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420622
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-14
Brief Title:
INDIcators for Clarifying the bAckground of exTreme Obesity in childRen
Sponsor:
University of Leipzig
Organization:
University of Leipzig
Study Overview
Official Title:
INDIcators for Clarifying the bAckground of exTreme Obesity in childRen INDICATOR
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDICATOR
Brief Summary:
The study investigates the genetic backgrounds of extreme childhood obesity using saliva sample and contains short online questionnaires on family history phenotypical characteristics and hunger behavior It is an observational study in a predefined cohort subjects with data in CrescNet aged 0-18 with BMI measurements above the 995th percentile Recruitment will initially be from CrescNet data through the cooperating pediatric and adolescent medical institutions associated with these initiative of data collection in Germany
Detailed Description:
In order to be able to investigate the genetic background of extreme obesity current BMI developments above the 995 BMI percentile extreme obesity are selected in the existing CrescNet register Pediatricians submitting the data will be informed about these cases They will be ask to re-identify the patient using the pseudonym CrescNet-ID maintained in the registry and to contact the family with a request to participate in the study The study physician of the study center at the Leipzig University Hospital will take over the study inclusion as well as all necessary clarifications and consents for the study and the genetic examination contained therein Since the potential probands may live anywhere in Germany telemedical contact between the study center and the family interested in participation will be used
In addition to the above-mentioned study inclusion the study physician is also responsible for instructing the family on the correct drawing collection and sending of saliva samples to the study center as well as instructing them on how to complete the hyperphagia questionnaire
At this appointment the proband is assigned an internal study identification number INDICATOR-ID Saliva sample and all questionnaires are assigned to this number
In addition to the above-mentioned study inclusion the study physician is also responsible for instructing the family on the correct drawing collection and sending of saliva samples to the study center as well as instructing them on how to complete the hyperphagia questionnaire
At this appointment the proband is assigned an internal study identification number INDICATOR-ID Saliva sample and all questionnaires are assigned to this number
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None