The primary aim of this study is to assess the impact of prolonged walking on fluid- and electrolyte balance in 32 patients with T2DM, compared with a matched group of 32 healthy control subjects, and 32 patients with T1DM, during the Nijmegen Four…
ID
Source
Brief title
Condition
- Diabetic complications
- Electrolyte and fluid balance conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Fluid balance (by means of body mass loss)
Secondary outcome
- Incidence of dehydration
- Urine output
- Fluid intake
- Electrolyte balance
- Heart rate
- Activity level
- Glucose homeostasis
Background summary
Type 2 Diabetes Mellitus (T2DM) represents a major health problem in the
Western society. Physical inactivity plays a detrimental role in the
development of T2DM, but also contributes to the increased cardiovascular risk.
To support this notion, exercise training has various beneficial effects,
including improvement in insulin sensitivity and cardiovascular risk factors.
Walking exercise represents an attractive type of exercise that can be
performed everywhere. However, relatively little is known about the immediate
effect of walking exercise training in T2DM.
When walking exercise is performed for prolonged periods, such as during the
Nijmegen 4-Day marches, subjects may develop a fluid- or electrolyte imbalance.
In a series of previous experiments, we found that fluid- and electrolyte
imbalance occurs more often in men, older subjects and subjects with
overweight/obesity. Because of these risk factors, T2DM patients may be at risk
for developing fluid- and electrolyte imbalance compared to healthy controls.
Moreover, relatively little is known about the impact of prolonged walking
exercise on glucose levels, which may be importantly influenced by this type of
exercise. We also want to include a group of Type 1 Diabetes Mellitus (T1DM)
patients. Similar to T2DM, exercise training has potent cardioprotective
effects, whilst relatively little is known about the acute effects of exercise.
Whether T1DM is associated with fluid- and electrolyte imbalance is currently
unknown.
Study objective
The primary aim of this study is to assess the impact of prolonged walking on
fluid- and electrolyte balance in 32 patients with T2DM, compared with a
matched group of 32 healthy control subjects, and 32 patients with T1DM, during
the Nijmegen Four Day Marches. As a secondary aim, we will examine glucose
homeostasis during prolonged walking exercise in a subgroup of T2DM, T1DM and
controls.
Study design
Observational study
Study burden and risks
During the 4-day marches, we will take daily venous blood samples and perform
non-invasive measurements to gain better insight into the hydration status of
subjects (such as body weight changes after exercise). In addition, continuous
glucose monitoring will be applied to measure glucose homeostasis as a pilot
study in a subgroup of 10 T2DM patients, 10 healthy control subjects, and 10
T1DM patients. For organization purposes, this will be performed a few weeks
before the 4-day marches. All measures, therefore, are minimally invasive and
not associated with an important health risk for these patients, and will
provide important and novel information about the impact of walking exercise in
patients and controls.
Geert Grooteplein Noord 21
6525 EZ Nijmegen
NL
Geert Grooteplein Noord 21
6525 EZ Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with T2DM
- Diagnosed with T1DM
Exclusion criteria
- Body weight lower than 36,5 kg
- Presence of an obstructive disease of the gastro-intestinal tract, including (but not only) diverticolosis and inflammatory intestinal disease.
- History of surgery of the intentines, excluding cholecystectomia and appendectomy
- Magnetic Resonance Imaging (MRI) planned during the period in which subjects have ingested the CorTempTM sensor or planned 48 h after the 4-Day Marches.
- pacemaker or presence of another electromedical apparatus;Besides these exclusion criteria we will not adhere to any other exclusion criteria. This is to ensure that our research population is as much akin to the general four days marching population as possible.
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 | NL40431.091.12 |