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

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ClinicalTrials.gov Identifier: NCT00760331
Recruitment Status : Active, not recruiting
First Posted : September 26, 2008
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
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Brief 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.

Condition or disease
Hepatocyte Nuclear Factor 1-beta

Detailed Description:

Biologic analysis and renal ultrasonography once a year.

After puberty or before kidney transplantation

  • Abdominal and pelvic MRI
  • Intravenous Glucose Tolerance Test
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function
Study Start Date : June 2008
Estimated Primary Completion Date : July 2033
Estimated Study Completion Date : December 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric patients presenting an abnormality of kidney developmentdue to TCF2 mutation or deletion.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760331


Locations
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France
CHU de Limoges
Limoges, France
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Vincent GUIGONIS, MD University Hospital, Limoges
More Information
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00760331    
Other Study ID Numbers: I06026
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: February 2015
Keywords provided by University Hospital, Limoges:
HNF1B
TCF2
MODY-5
CAKUT
Anomaly of renal development