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Optimization of exercise therapy in type 2 diabetes mellitus

Conditions
adult onset diabetes
Diabetes type 2
10018424
Registration Number
NL-OMON39148
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
56
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, a-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, a-blockers, calcium antagonists.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Average values of glucose concentrations computed during the 24 h - continuous<br /><br>subcutaneous glycemia monitoring (CGMS) (GlucoDay®, A. Menarini) following<br /><br>exercise under various oxygen conditions.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>• Workload in watts and VO2max during maximal exercise test.<br /><br>• Performance on an sub-maximal exercise test (50% VO2max - relative workload<br /><br>to oxygen conditions).<br /><br>• Muscle blood flow (NIRS Portamon®)<br /><br>• Cardiac output (noninvasive thoracic bio-impedance method using Haemoseis<br /><br>256®)<br /><br>• Lung diffusing capacity (Master Screen PFT® (Viasys/Jaeger)<br /><br>• Sublingual microcirculation imaging (Sidestream Dark Field Imaging®)<br /><br>• Measurements of the mitoPO2 and mitoVO2 by the PpIX triplet state lifetime<br /><br>technique during every sub-maximal test.<br /><br>• Adrenaline and noradrenaline concentrations (plasma).<br /><br>• HbA1c (blood), plasma glucose</p><br>
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