The primary aim of the study is to increase knowledge about the short and medium term effect of an intensive period of (organised) exercise on the level of HbA1c in the blood of diabetics. This can help caregivers in giving lifestyle advice to…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in HbA1c in mmol / mol. The intervention is considered effective with a
decrease in HbA1c of 10% or more (5.39 mmol / mol).
Secondary outcome
*% of patients who reach the target value (* 53 mmol / mol or * 58 mmol / mol,
depending on age, duration of illness and medication)
*% of patients going from orange (75 mmol / mol) to green (53 mmol / mol)
*% of patients going from red (91 mmol / mol) to green (53 mmol / mol)
* Experiences of patients with the POCT of HbA1c
* Change in well-being
* Change in weight
Background summary
The risk of microvascular and macrovascular complications in people with
diabetes increases as the HbA1c value in the blood increases. The HbA1c value
provides information about the average tuning of blood sugar for diabetics over
a longer period of time.
Previous studies have shown that exercise has a positive influence on HbA1c in
people with diabetes. Never before has repeated research been conducted into
the effects of an intensive period of (organised) walking on blood HbA1c levels
in the Dutch population of diabetes patients.
Study objective
The primary aim of the study is to increase knowledge about the short and
medium term effect of an intensive period of (organised) exercise on the level
of HbA1c in the blood of diabetics. This can help caregivers in giving
lifestyle advice to people with diabetes. Secondary objective is insight into
experiences with a scientifically proven, accurate and reliable, but hardly
used point-of-care testing method for determining the HbA1c content with blood
from a finger prick. The results from this study can be used by GPs when
choosing whether to use the new measurement method in their practices.
Study design
Cohort study.
Measurements:
- POCT measurement of HbA1c during last day of the National Diabetes Challenge,
after 3 months and after 6 months
- Baseline value of HbA1c retrieved retrospectively at central laboratory
- Patient questionnaires during last week of National Diabetes Challenge, after
3 months and after 6 months
Study burden and risks
For participants, a drop of blood is collected at three moments by means of a
finger prick. This takes place once during the closing event of the National
Diabetes Challenge and twice at a star-shl service point. The physical burden
for patients of the finger prick is very limited and the risks are nil. There
is a time burden for patients due to the two extra visits to the star-shl
service point and the completion of three times a short questionnaire. The
questions will not entail any psychological burden; no sensitive topics will be
discussed.
Bredaseweg 165
Etten-Leur 4872 LA
NL
Bredaseweg 165
Etten-Leur 4872 LA
NL
Listed location countries
Age
Inclusion criteria
Adult patient (18 years or older).
Diagnosed with Type 1 or 2 Diabetes Mellitus.
Participant in the National Diabetes Challenge.
Registered with one of the GP practices in the star-shl diagnostic center
regions (Rotterdam region, Etten-Leur region).
Exclusion criteria
No informed consent
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 | NL70687.091.19 |
| Other | NL7818 |