Wolfram Syndrome and WFS1-related Disorders International Registry and Clinical Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorWashington University School of Medicine

About this trial

In this study, the investigators hypothesize that studying monogenic variants with strong effect associated with severe insulin deficiency of Wolfram syndrome will provide important insights into the more complex type 1 and type 2 diabetes mellitus.

Aim 1. Establish and maintain a registry of patients with Wolfram syndrome. An Internet based registry will be employed to enroll participants with the clinical diagnosis of Wolfram syndrome (insulin dependent DM and bilateral OA). Clinical information regarding age of diagnosis and progression of the disease will be collated and analyzed to better define its natural history, along with potential metabolic phenotypes such as glucose intolerance of heterozygous parents and unaffected sibs.

If not already completed, blood for WFS1 sequence analysis will be obtained on the participants (parents and sibs also for control purposes) and sent to a CLIA certified lab to define the mutation. This information will benefit patient families and referring physicians by providing a genetic diagnosis and where indicated. The Wolfram Syndrome Registry will foster international collaborations to more efficiently and systematically collect Wolfram syndrome patients and their clinical and experimental data.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diabetes mellitus <16 yrs

Optic atrophy <16 yrs

Diabetes insipidus

Diabetes mellitus >16yrs

Disqualifiers

None

Trial population

Any patient worldwide with a clinical diagnosis of Wolfram syndrome and with access to the Internet can be enrolled in the Registry. Since the disease usually manifests in the first decade of life and tends to have an inevitably progressive course, participation of minors is important for establishing the natural course of the disease.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Changes in C-peptide levels in participants

The investigators will monitor base-line C-peptide levels in participants' blood.

Time frame
10 years

Secondary outcomes

1

Changes in best-corrected visual acuity in participants measured by Snellen optotype

Best-corrected visual acuity will be measured by Snellen optotype. Higher logMar scores indicate worse vision

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

American Diabetes Association

Collaborator

National Institutes of Health (NIH)

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator