Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06239064
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-01-25
Brief Title:
Early Genetic Identification of Obesity
Sponsor:
Rolfs Consulting und Verwaltungs-GmbH RCV
Organization:
Rolfs Consulting und Verwaltungs-GmbH RCV
Study Overview
Official Title:
Whole Genetic Approach in Early Genetic Identification of Obesity WEGIO
Status:
RECRUITING
Status Verified Date:
2024-09
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:
WEGIO
Brief Summary:
TITLE Whole genetic approach in Early Genetic Identification of Obesity WEGIO
DESIGN Multicenter epidemiological study
STUDY POPULATION Participants at risk for a syndromic or a monogenic genetic obesity incl participants clinically diagnosed with Bardet-Biedl-Syndrome BBS
NUMBER OF PARTICIPANTS 1000 for initial genetic sequencing and app 40 for the follow-up documentation
COORDINATING INVESTIGATOR Prof Dr Arndt Rolfs
DESIGN Multicenter epidemiological study
STUDY POPULATION Participants at risk for a syndromic or a monogenic genetic obesity incl participants clinically diagnosed with Bardet-Biedl-Syndrome BBS
NUMBER OF PARTICIPANTS 1000 for initial genetic sequencing and app 40 for the follow-up documentation
COORDINATING INVESTIGATOR Prof Dr Arndt Rolfs
Detailed Description:
TITLE Whole genetic approach in Early Genetic Identification of Obesity WEGIO
DESIGN Multicenter epidemiological study
STUDY POPULATION Participants at risk for a syndromic or a monogenic genetic obesity incl participants clinically diagnosed with Bardet-Biedl-Syndrome BBS
NUMBER OF PARTICIPANTS 1000 for initial genetic sequencing and app 40 for the follow-up documentation
COORDINATING INVESTIGATOR Prof Dr Arndt Rolfs
PARTICIPATING COUNTRY Germany
TREATMENT Not applicable
PRIMARY OBJECTIVE To investigate the prevalence of BBS in an at-risk population
SECONDARY OBJECTIVES
To explore genotype-phenotype correlation
To assess genotypes distribution in Germany and compare to other countries
To identify new genesvariants
To investigate clinical characteristics in individuals diagnosed with BBS
DURATION OF RECRUITMENT 32 months - total
24 months the recruitment of 1000 subjects
27 months follow up visits
32 months close out of sites
INCLUSION CRITERIA
Informed consent is obtained from the participantparentlegal guardian
The participant is 2 years of age or older
For a participant between 2 and 18 years of age
The participant has and had a body weight more than 97th percentile before the age of 6
The participant has one or more of the following symptoms
rodcone dystrophy renal abnormalities ataxia syndactyly polydactyly brachydactyly hyperphagia cognitive impairment speech delay hypogonadism
For a participant who is 18 years of age or older
The participant has BMI 30 kgm2
The participant had a body weight more than 97th percentile before the age of 6 years
The participant has rodcone dystrophy
The participant is 2 or more years of age is clinically diagnosed with Bardet-Biedl-Syndrome BBS or is a sibling of an individual diagnosed with BBS via the WEGIO study
DESIGN Multicenter epidemiological study
STUDY POPULATION Participants at risk for a syndromic or a monogenic genetic obesity incl participants clinically diagnosed with Bardet-Biedl-Syndrome BBS
NUMBER OF PARTICIPANTS 1000 for initial genetic sequencing and app 40 for the follow-up documentation
COORDINATING INVESTIGATOR Prof Dr Arndt Rolfs
PARTICIPATING COUNTRY Germany
TREATMENT Not applicable
PRIMARY OBJECTIVE To investigate the prevalence of BBS in an at-risk population
SECONDARY OBJECTIVES
To explore genotype-phenotype correlation
To assess genotypes distribution in Germany and compare to other countries
To identify new genesvariants
To investigate clinical characteristics in individuals diagnosed with BBS
DURATION OF RECRUITMENT 32 months - total
24 months the recruitment of 1000 subjects
27 months follow up visits
32 months close out of sites
INCLUSION CRITERIA
Informed consent is obtained from the participantparentlegal guardian
The participant is 2 years of age or older
For a participant between 2 and 18 years of age
The participant has and had a body weight more than 97th percentile before the age of 6
The participant has one or more of the following symptoms
rodcone dystrophy renal abnormalities ataxia syndactyly polydactyly brachydactyly hyperphagia cognitive impairment speech delay hypogonadism
For a participant who is 18 years of age or older
The participant has BMI 30 kgm2
The participant had a body weight more than 97th percentile before the age of 6 years
The participant has rodcone dystrophy
The participant is 2 or more years of age is clinically diagnosed with Bardet-Biedl-Syndrome BBS or is a sibling of an individual diagnosed with BBS via the WEGIO study
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