HbA2 Leuven and Its Impact on HbA1c Results (HbA2 Leuven)

July 6, 2015 updated by: Universitaire Ziekenhuizen KU Leuven
The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on routine HbA1c measurements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Family history of HbA2 Leuven mutation.

Exclusion Criteria:

  • Any condition inhibiting simple blood withdrawal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HbA2 Leuven
Presence of HbA2 Leuven mutation, demonstrated by molecular diagnosis on blood sample.
Other: Blood withdrawal
Other Names:
  • Impact of mutation on routine HbA1c measurements.
Genetic: Blood withdrawal
Other Names:
  • Demonstration of HbA2 Leuven mutation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demonstration of presence/absence of HbA2 Leuven mutation
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Demonstration of impact of HbA2 Leuven mutation on routine HbA1c measurements
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Davy MJ Kieffer, PhD, Universitaire Ziekenhuizen KU Leuven
  • Study Chair: Pieter Gillard, MD, PhD, Universitaire Ziekenhuizen KU Leuven
  • Study Chair: Koen Desmet, PharmD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 6, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • S55709 (Other Identifier: UZLeuven)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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