跳至主要内容
临床试验/NCT06420622
NCT06420622招募中不适用

INDIcators for Clarifying the bAckground of exTreme Obesity in childRen (INDICATOR)

University of Leipzig1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Prevalence of each monogenetic obesity

研究概览

简要总结

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 measurement(s) above the 99.5th 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.

详细描述

In order to be able to investigate the genetic background of extreme obesity, current BMI developments above the 99.5 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Test subjects older 5 years:
  • •BMI SDS between 0-5 years > 1.881 (= p97) BMI SDS between 5 and 18 >2.567 (=p99.5) Parents and subjects agree that the study information will be provided during a telemedical consultation by the study physician

排除标准

  • •Known cause of servere early obesity

结局指标

主要结局

Prevalence of each monogenetic obesity

时间窗: 2 years

trait among children with early onset severe obesity

Typical patterns of weight gain for each form of obesity

时间窗: 2 years

distinguish monogenetic obesity from classical polygenetic forms

次要结局

  • Statements about spatial distribution(2 years)
  • Role of hyperphagia symptoms(2 years)

研究者

发起方
University of Leipzig
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antje Koerner, Prof. Dr. med.

Prof. Dr. med.

University of Leipzig

研究点 (1)

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