Skeletal muscle phenotype and its association with glucometabolic status in patients with type 2 diabetes, overweight-to-obese and healthy individuals.
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00033194
- Lead Sponsor
- Deutsches Luft- und Raumfahrtzentrum, Institut für Luft- und Raumfahrtmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Individuals with T2D:
• Female and male individuals with T2D diagnosis according to ADA criteria
• No participation in structured exercise programs for =6 months
• BMI between 19 and 35 kg/m2
• Age between 24 and 69 years
• Signed informed consent
Overweight-toobese individuals:
• Female and male participants with
normal glucose tolerance
• Sex-, age- and physical activity levelmatched to individuals with T2
• No participation in structuredexercise programs for =6 months
• BMI between 25 to 40 kg/m2
• Signed informed consent
Normal-weight individuals:
• Metabolically healthy female and male participants with normal glucose tolerance
• Sex-, age- and physical activity levelmatched to individuals with T2D
• No participation in structured exercise programs for =6 months
• BMI between 19 to 24.9 kg/m2
• Signed informed consent
• Contra-indications against biopsy (e.g. impaired hemostasis,
keloidosis, history of adverse reactions to local anesthesia or to surgical
procedures)
• Contra-indications against magnetic resonance imaging, including metal implants or other osteosynthesis material, not MRI compatible stents, clips
etc., pacemakers, infusion pumps, claustrophobia
• neurological conditions
including strokes, brain hemorrhage, aneurysms, brain tumors,
neurodegenerative diseases, seizures, head trauma based on medical history
• Cardiovascular conditions including acute coronary artery disease with coronary angina or myocardial infarction in the last 6 months,
heart failure (NYHA III-IV), ventricular or atrial arrhythmias, pacemaker, recurrent syncope,
• Autonomic disorders
• Chronic pulmonary diseases (COPD, severe asthma, pulmonary fibrosis)
• Sleep apnea, insomnia or narcolepsy based on medical history
• Any other medical condition that the investigators consider contraindication to the study procedures that would make it unsafe or
confound the measurements, e.g. medication with insulin, sulfonylurea, glinide,medication influencing hemostasis (e.g. ASS, anticoagulants)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Metabolic in vivo analyses: <br>- Insulin sensitivity via hyperinsulinemic euglycemic clamp (HEC)<br>- Maximal aerobic capacity and detailed muscle function (strength, jump height)<br>- Liver and muscle lipid content via non-invasive 1H-magenitic resonance spectroscopy (MRS)<br>- Liver volume and liver glycogen via non-invasive 13C-MRS<br>- Abdominal fat 6-point Dixon magnetic resonance imaging (MRI)<br>- Energy expenditure and substrate utilization (carbohydrate and fat) via indirect calorimetry <br>at rest and during insulin-stimulated conditions<br><br>Mechanical in vivo analyses:<br>- Maximal aerobic capacity and maximal muscle force production<br>- Grip strength<br>- Body composition via body plethysmography and bio-electrical impedance analysis<br>
- Secondary Outcome Measures
Name Time Method