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Glucose transport and mitochondrial function in type 1 diabetes mellitus

Recruiting
Conditions
diabetes
10018424
Registration Number
NL-OMON52326
Lead Sponsor
Vrije Universiteit
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
41
Inclusion Criteria

In order to be eligible to participate in this study, participants with T1DM
must meet all of the following criteria:
• Individuals with T1DM with a diagnosed disease duration of 1 - 45 years
• Male or female
• Aged between 18-65 years

In order to be eligible to participate in this study, healthy control
participants must meet all of the following criteria:

• No chronic health conditions and between the ages of 18-65

Exclusion Criteria

• History of asthma, stroke, chronic obstructive pulmonary disease, congestive
heart failure, heart surgery, or congenital heart diseases
• Current treatment with drugs known to interfere with metabolism e.g. systemic
corticosteroids, statins, SGLT2 inhibitors, GLP1 receptor agonists
• Are current smokers or have been a regular smoker within the last 12 months
• Insulin pump therapy
• Symptomatic autonomic or distal neuropathy
• BMI >30 due to adiposity, since this is known to cause difficulties in
obtaining muscle biopsies.
• Pregnancy
• Recent acute myocardial infarction (<6 months)
• Uncontrolled arrhythmia/severe conduction disorder (atrial fibrillation or
second/third degree AV block) causing hemodynamic compromise
• Implantable pacemaker or other cardiac device with complete ventricular pacing
• Uncontrolled heart failure with hemodynamic compromise
• Uncontrolled hypertension (Systolic Blood Pressure >150 mmHg and Diastolic
Blood Pressure > 100 mmHg on repeated measurements)
• Active infection, anaemia, severe renal dysfunction (estimated Glomerular
filtration rate <30 ml/min/1,73m2) likely to significantly impact on exercise
performance
• Chronic illness (including orthopaedic, endocrinological, haematological,
malignant, gastrointestinal, neurological, muscle or inflammatory disorders)
likely to significantly impact on exercise performance
• > 6 alcohol units per day or >14 alcohol units per week
• Use of anticoagulants or anti platelet therapy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Main study parameters: The differences in markers of insulin-independent<br /><br>glucose uptake, parameters of mitochondrial function and exercise tolerance<br /><br>between T1DM and control groups both before and after the exercise training<br /><br>intervention.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary Study Parameters: The differences in exercise tolerance and aerobic<br /><br>function parameters between T1DM and control groups before and after the<br /><br>exercise training intervention, and their relationships with markers of<br /><br>mitochondrial function.</p><br>
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