Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function

Hepatocyte Nuclear Factor 1-beta Clinical Trial

— TCF2  

Official title:

A Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00760331
• Other study ID #: I06026
• Status: Active, not recruiting
• Start date: June 2008
• Est. completion date: December 2033

Study information

• Verified date: February 2015
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2 mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients is unknown.The aim of this study is to follow a cohort of patients with TCF2 mutation and initially presenting renal anomalies alone.

Description:

Biologic analysis and renal ultrasonography once a year.

After puberty or before kidney transplantation

• Abdominal and pelvic MRI

• Intravenous Glucose Tolerance Test

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2033
• Est. primary completion date: July 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patients presenting an anomaly of renal development due to TCF2 mutation

• Age<18 years old

Exclusion Criteria:

• Anomaly of renal development without TCF2 mutation

• Age=18 years old

• Parents or patients refusing to participate to the study

Related Conditions & MeSH terms

• Hepatocyte Nuclear Factor 1-beta

Locations

Country	Name	City	State
France	CHU de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France,