HbA2 Leuven and Its Impact on HbA1c Results

Not Applicable

Completed

• Conditions: Family Study HbA2 Leuven Mutation.
• Interventions: Genetic: Blood withdrawal

• Registration Number: NCT01909648
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on routine HbA1c measurements.

Detailed Description

HbA2 Leuven mutation will be investigated using molecular diagnostic techniques.

Interference on HbA1c measurements will be assessed in HbA2 Leuven carriers using different methodologies.

Study Timeline

• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Study Start: 2013-09
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-06
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Family history of HbA2 Leuven mutation.

Exclusion Criteria

• Any condition inhibiting simple blood withdrawal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HbA2 Leuven	Blood withdrawal	Presence of HbA2 Leuven mutation, demonstrated by molecular diagnosis on blood sample.

Primary Outcome Measures

Name	Time	Method
Demonstration of presence/absence of HbA2 Leuven mutation	1 year

Secondary Outcome Measures

Name	Time	Method
Demonstration of impact of HbA2 Leuven mutation on routine HbA1c measurements	1 year

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium