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Hidden weight problem: PKU adults face higher obesity risk, scientists investigate why

NCT ID NCT07703020

Knowledge-focused Sponsor: Christel Tran Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This observational study looks at how common overweight and obesity are in adults with phenylketonuria (PKU) and what factors might contribute. Researchers will collect clinical data, lab results, and questionnaire responses on diet, exercise, and mental health from 100 adults at metabolic centers in Switzerland and Austria. The goal is to better understand weight gain in PKU to help design future prevention strategies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could identify key risk factors for obesity in adults with PKU, pointing toward better preventive strategies and tailored dietary guidance.
What could go wrong
As a small, cross-sectional pilot study, it can only show associations, not causes. Results may not apply to all PKU patients or lead to clear interventions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will be recruited from adult metabolic clinics and inherited metabolic disease centers in Switzerland (CHUV in Lausanne, HUG in Geneva, Inselspital in Bern, University Hospital Zurich, University Hospital Basel, Kantonsspital St. Gallen) and Austria (AKH Universitätsklinikum, Vienna). This population represents adults with PKU who are actively followed in specialized reference centers, reflecting a mix of patients treated since birth through newborn screening programs and those diagnosed later in life

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed diagnosis of phenylketonuria (PKU) by biochemical and/or molecular testing. * Age ≥ 18 years. * Ability to provide written informed consent. Exclusion Criteria: * Pregnant or lactating women. * Inability to follow the study procedures (e.g., due to language barriers). * Eligible participants who refuse to be informed of any important health concern discovered during the study. * Investigators, their family members, employees, or anyone with a personal link to the investigator other than a doctor-patient relationship.

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Conditions

The condition(s) this trial relates to.

Obesity phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Phenylketonuria (PKU)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lausanne University Hospital

    Lausanne, Canton of Vaud, 1011, Switzerland

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