HbA2 Leuven and Its Impact on HbA1c Results

Family Study HbA2 Leuven Mutation. Clinical Trial

— HbA2 Leuven  

Official title:

HbA2 Leuven and Its Impact on HbA1c Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909648
• Other study ID #: S55709
• Secondary ID: S55709
• Status: Completed
• Phase: N/A
• First received: July 24, 2013
• Last updated: July 6, 2015
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Family history of HbA2 Leuven mutation.

Exclusion Criteria:

• Any condition inhibiting simple blood withdrawal.

Related Conditions & MeSH terms

• Family Study HbA2 Leuven Mutation.

Intervention

Other:
• Blood withdrawal

Genetic:
• Blood withdrawal

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of presence/absence of HbA2 Leuven mutation		1 year
Secondary	Demonstration of impact of HbA2 Leuven mutation on routine HbA1c measurements		1 year