To determine the natural variation of HbA1c in a group of older volunteers without DM during a period of 2 years.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The biological variation of HbA1c in older volunteers without DM for a period
of 2 years.
Secondary outcome
Not applicable.
Background summary
Monitoring the treatment of diabetes mellitus type 2 (DM2) patients takes place
by measuring the glycated haemoglobin (HbA1c) concentration. HbA1c reflects the
average blood glucose level over a period of 1-3 months. A change in HbA1c is
clinically relevant if it exceeds the normal variation in HbA1c over time
(measured in healthy individuals), termed the biological variation. Studies
have already assessed the biological variation occurring within a few months,
however patients diagnosed with DM2 generally are monitored at least once a
year when their diabetes is relatively stable. Hence, monitoring of DM2
patients would benefit if the biological variation of HbA1c over 1-2 years is
known. This would allow for better assessment of observed changes in HbA1c
levels in patienst with DM2.
Study objective
To determine the natural variation of HbA1c in a group of older volunteers
without DM during a period of 2 years.
Study design
Observational study.
Through email and flyers with study information personnel of the Isala hospital
will be recruited as volunteers. About 40 volunteers (20 males, 20 females)
without diabetes mellitus (DM) are followed for a period of 2 years. Five times
a year (1x in +/- 11 weeks) they undergo a venapuncture for 2 test tubes of 4
ml blood each. E. Lenters-Westra (research analist) summons the volunteers each
time, executes the venapunctures and asks about any medical particularities.
She and A. Vos monitor the progress of the study. The venapunctures are
performed at the clinical chemical laboratorium of the Isala hospital. De test
tubes will be frozen and analyzed after 2 years at the end of the study. Blood
from the test tubes are tested on HbA1c and additional tests that can possibly
influence the HbA1c: hemoglobin, mean corpuscular volume, hematocrit,
creatinine, urea, alanine transaminase, aspartate transaminase and
gamma-glutamyltransferase. Abnormal test results will be shared with the
volunteer.
Study burden and risks
Five times a year (once in +/- 11 weeks) during 2 years a venapuncture is
performed and 2 test tubes of 4 ml each are collected during each venapuncture.
Volunteers are asked at each venapuncture if there were any medical
particularities after their previous venapuncture. Risk of complications
because of the venapuncture are small. The result, the long-term biological
variation in volunteers without DM, surpasses the minimal risk of complication
during venapuncture. The venapunctures are performed on the same location where
the volunteer works. Mean duration of the visit will be about 5-10 minutes.
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
Male or female
45 - 70 years old
No diabetes mellitus
The previous year no major diseases such as cancer and/or large operations
No immune system modulating medication
Exclusion criteria
Younger than 45 years or older than 70 years
Diabetes mellitus
The previous year major diseases like cancer of large operations
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63930.075.18 |