Whole Genetic Approach in Early Genetic Identification of Obestity

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TITLE: Whole genetic approach in Early Genetic Identification of Obesity (WEGIO)

DESIGN: Multicenter epidemiological protocol

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:

INTERIM EVALUATION: 1,000 for initial genetic sequencing and app. 40 for follow-up documentation. There will be an interim evaluation after 300 patients being enrolled

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 genes/variants

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 participant or from the parent/legal guardian and 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 years and the participant has one or more of the following symptoms:

Rod/cone 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 kg/m2 and the participant had a body weight more than 97th percentile before the age of 6 years and the participant has rod/cone 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 Overview

Start Date
January 24, 2024
Completion Date
March 1, 2027
Enrollment
1000
Date Posted
February 2, 2024
Gender
All

Locations

Full Address
University of Rostock
Rostock, Mecklenburg-Vorpommern 18055, Germany

Eligibility

Study Population
participants suspected to genetic obesity
Minimum Age (years)
2
Eligibility Criteria
Inclusion Criteria:

Informed consent is obtained from the participant or from the parent/legal guardian and
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 years and
The participant has one or more of the following symptoms:
Rod/cone 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 kg/m2 and
The participant had a body weight more than 97th percentile before the age of 6 years and
The participant has rod/cone 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

Exclusion Criteria:

not fulfilling the inclusion the inclusion criteria

Study Contact Info

Study Contact Name
Prof. Arndt Rolfs, PhD, MD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Detailed Description
TITLE: Whole genetic approach in Early Genetic Identification of Obesity (WEGIO)

DESIGN: Multicenter epidemiological protocol

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:

INTERIM EVALUATION: 1,000 for initial genetic sequencing and app. 40 for follow-up documentation. There will be an interim evaluation after 300 patients being enrolled

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 genes/variants

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 participant or from the parent/legal guardian and 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 years and the participant has one or more of the following symptoms:

Rod/cone 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 kg/m2 and the participant had a body weight more than 97th percentile before the age of 6 years and the participant has rod/cone 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
NCTid (if applicable)
NCT06239064