Eating Disorders in Patients With Phenylketonuria | NCT07698743

Studies
Eating Disorders in Patients With Phenylketonuria

NCT07698743

Sponsor

Central Hospital, Nancy, France

Status

Recruiting

Last Update Posted

Jul 13, 2026Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Phenylketonuria

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2025Actual

Primary Completion Date

Jan 1, 2028Estimated

Completion Date

Apr 2, 2028Estimated

First Submitted Date

Jul 7, 2026

First Submission Date that Met QC Criteria

Jul 7, 2026

First Posted Date

Jul 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2026

Last Update Posted Date

Jul 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The prevalence of eating disorders and BMI are significantly higher in PKU patients than in the general population. The protein-restricted diet associated with high carbohydrate intake and the severity of the genetic defect and disease can lead to weight gain in these patients; However, the link between restrictive diets, EDs, and obesity has not been demonstrated in patients with PKU. These issues remain poorly explored, meaning that patients may not be detected and treated.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phenotypes related to TCA in the PCU cohort of the Reference Center for Hereditary Metabolic Diseases		from january 2026 to january 2028

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects followed for PKU at Nancy University Hospital
Subjects willing to participate

Exclusion Criteria:

Subjects not villing to participate

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects followed for PKU at Nancy University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eva Feigerlova, MD PhD MMEd	Contact	+330383154796		e.feigerlova@chru-nancy.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Nancy	Recruiting	Nancy		54000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40378670	Result	van Wegberg AMJ, MacDonald A, Ahring K, Belanger-Quintana A, Beblo S, Blau N, Bosch AM, Burlina A, Campistol J, Coskun T, Feillet F, Gizewska M, Huijbregts SC, Leuzzi V, Maillot F, Muntau AC, Rocha JC, Romani C, Trefz F, van Spronsen FJ. European guidelines on diagnosis and treatment of phenylketonuria: First revision. Mol Genet Metab. 2025 Jun;145(2):109125. doi: 10.1016/j.ymgme.2025.109125. Epub 2025 Apr 30.

ID	Term
D020739	Brain Diseases, Metabolic, Inborn
D001928	Brain Diseases, Metabolic
D001927	Brain Diseases
D002493	Central Nervous System Diseases