1. Measurement of the 24-hour glycemic profile in response to acute submaximal hypoxic and hyperoxic exercise in order to determine its effectiveness and select the most efficient method in reducing post-exercise hyperglycemia prevalence in…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Average values of glucose concentrations computed during the 24 h - continuous
subcutaneous glycemia monitoring (CGMS) (GlucoDay®, A. Menarini) following
exercise under various oxygen conditions.
Secondary outcome
• Workload in watts and VO2max during maximal exercise test.
• Performance on an sub-maximal exercise test (50% VO2max - relative workload
to oxygen conditions).
• Muscle blood flow (NIRS Portamon®)
• Cardiac output (noninvasive thoracic bio-impedance method using Haemoseis
256®)
• Lung diffusing capacity (Master Screen PFT® (Viasys/Jaeger)
• Sublingual microcirculation imaging (Sidestream Dark Field Imaging®)
• Measurements of the mitoPO2 and mitoVO2 by the PpIX triplet state lifetime
technique during every sub-maximal test.
• Adrenaline and noradrenaline concentrations (plasma).
• HbA1c (blood), plasma glucose
Background summary
DM2 is considered a growing pandemic problem. In accordance, DM related
complications, like retinopathy, neuropathy, myocardial infarction and stroke
will be experienced more frequently in the future. Vastly enlarging diabetes
population will impose an enormous burden on our healthcare system and the
quality of life of the diabetes patients. Therefore, besides pharmacological
and nutritional strategies, other therapeutic options are required. The latter
would amplify the efficacy of complex prevention and treatment programs in DM2.
Regular physical activity is considered an important cornerstone in the
prevention and treatment of DM2 patients. In particular, it has been documented
that regular physical activity improves lipid profile, cardiovascular fitness,
quality of life and glycemic control. The latter is a direct and independent
risk factor for the development of DM2 complications.
On the other hand, it has been shown that an acute bout of exercise immediately
reduces the level of hyperglycemia in DM2 subjects, along with diet and
medication.
This research aims to improve our understanding on effectiveness of a single
bout of exercise in more physiologically challenging oxygen conditions in DM2
patients. Obtained results will help us selecting the most beneficial method in
order to further improve treatment strategies/interventions in DM2.
Study objective
1. Measurement of the 24-hour glycemic profile in response to acute submaximal
hypoxic and hyperoxic exercise in order to determine its effectiveness and
select the most efficient method in reducing post-exercise hyperglycemia
prevalence in comparison with normoxic conditions.
2. Comparison and selection of oxygen conditions which amplify stimulation of
muscle blood flow/ improve exercise tolerance during exertion. Moreover,
obtained peripheral and central hemodynamic/respiratory responses will
demonstrate the net result of acute exercise in various oxygen conditions.
The latter will contribute to optimize exercise therapy in DM2 patients with
impaired exercise tolerance and diabetes complications.
Study design
SIngle-blinded, case-control, observational study.
Intervention
Patients will undergo 1 maximal exercise test. Subaequently, they will be
randimized and blinded to 3 steady-state sub-maximal tests (30 min each) in
various oxygen conditions (21%O2-79%N2 / 14%O2-86%N2 / 35%O2-65%N2, 4-8L/min)
on separate days. Additionally, subjects will be monitored by noninvasive
equipment for hemodynamic and cardiorespiratory measurements. During the
experimental trial blood glucose profiles of subjects will be monitored by
portable CGMS devices for 2 days. Total time of participation in the study
equals 12 weeks.
Study burden and risks
The subjects will follow 1 normoxic maximal exercise test (screening and
pre-testing) on a bicycle using spiro-ergometry, ECG and non-invasive blood
pressure monitoring. Subsequently, 3 submaximal steady-state exercise tests
will be performed (30 minutes each) under hypoxic, hyperoxic and normoxic
conditions. 7-day breaks will be preserved between each test. Blood samples
will obtained once during screening, pre-testing (9ml). During submaximal
testing blood will be withdrawn every 15 minutes (0,15,30 min) from venous
punction (3ml each sample).
During the submaximal trials(3 days each) the subjects will be monitored by
continuous glycemia monitoring system (CGMS) (GlucoDay®, A. Menarini) for 48
hours.
Measurements of a hemodynamic response will be performed by the noninvasive
Haemoseis 256®, PortaMon®, Sidestream Dark Field imaging devices during every
sub-maximal test. Respiratory manouvers (prior and post every sub-maximal test)
will be performed using a noninvasive PFT Master Screen
The subjects will be provided with standardized diet during the trial (3x2days)
matched for their body mass (6 meals and 6 snacks). The patients will be asked
to report consumed nutrition products prior each submaximal testing period (2
days).
During exercise testing the risk of a hypoglycemic event is low considering
moderate-intensity exercise trial. If necessary carbohydrate solutions or in
case of loss of consciousness, Glucagon (Glycagen®, 1 mg dissolved in 1 ml) are
available.
Besides the direct therapeutic effects, both interventions are expected to
improve general health and well-being.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Diabetes patients(n=12):
• Type 2 Diabetes Mellitus >3 months.
• Age: 40-65 years.
• BMI between 27 and 35 kg/m2.
• Formal permission to participate in the study by signing an informed consent form.
Healthy subjects(n=20):
• Age:18-40 years.
• BMI:23-26 kg/m2
• Formal permission to participate in the study by signing an informed consent form.
Overweight /Obese subjects - glucosetolerant(n=12):
Age: 40-65 years;
BMI >27 kg/m2;
HbA1c <6.0%;
Formal permission to participate in the study by signing an informed consent form.
Overweight /Obese subjects - glucoseintolerant(n=12):
Age: 40-65 jaar;
BMI > 27 kg/m2;
HbA1c >=6.0%;
Formal permission to participate in the study by signing an informed consent form.
Exclusion criteria
• Cardiovascular disease: objective heart failure (ejection fraction <35%), electrocardiographically diagnosed cardiac ischemia or symptomatic peripheral vascular disease diagnosed by Doppler ultrasound investigation
• Serious orthopedic of neurological conditions precluding an exercise test.
Healthy subjects:
• Positive signs of cardiac ischaemia on the ECG (ST>2mm) during the incremental exercise test;
• Orthopaedic impairments that would limit participation in the study.
Obese volunteers - glucose tolerant:
• Positive signs of cardiac ischaemia on the ECG (ST>2mm) during the incremental. exercise test;
• Orthopaedic impairments that would limit participation in the study.
• Use of β-blockers, α-blockers, calcium antagonists.
Obese volunteers - glucose intolerant:
• Positive signs of cardiac ischaemia on the ECG (ST>2mm) during the incremental. exercise test;
• Orthopaedic impairments that would limit participation in the study.
• Use of β-blockers, α-blockers, calcium antagonists.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-006237-42-NL |
| CCMO | NL39085.078.12 |