NCT07698743

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Dec 2025Apr 2028

Study Start

First participant enrolled

December 4, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2028

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Phenylketonuria

Outcome Measures

Primary Outcomes (1)

  • Phenotypes related to TCA in the PCU cohort of the Reference Center for Hereditary Metabolic Diseases

    from january 2026 to january 2028

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects followed for PKU at Nancy University Hospital

You may qualify if:

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

You may not qualify if:

  • Subjects not villing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40378670RESULT

Related Links

MeSH Terms

Conditions

Phenylketonurias

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Eva Feigerlova, MD PhD MMEd

CONTACT

+330383154796e.feigerlova@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

December 4, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 2, 2028

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations

FR(1)