Glucose Metabolism Disorders, Local Glucose Uptake
Conditions
Keywords
Lupin Protein, Glucose Metabolism, GLUT4, Muscle Unloading, Neuromuscular Electrical Stimulation
Brief summary
The present study aimed to investigate whether a daily intake of lupin protein and a neuromuscular electrical stimulation training twice a day can improve local glucose uptake into m. soleus during a 60 day unloading phase with a special unloading device, the HEPHAISTOS orthosis (HEP).
Detailed description
The 60 day unloading intervention with the HEPHAISTOS unloading device had the following key objectives: primary hypothesis: * Assesment and evaluation of insulin sensitivity and local glucose uptake in the unloaded m. soleus and whether it can be improved by dietary supplementation of lupin seeds and neuromuscular electrical stimulation. secondary hypotheses: * Assesment and evaluation of unloading-induced reductions in muscle mass and whether they can be mitigated by dietary supplementation of lupin seed and neuromuscular electrical stimulation. * Assesment and evaluation of whole-body glycemic effects of the interventions.
Interventions
DIETARY_SUPPLEMENTlupin protein
19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)
OTHERNeuromuscular electrical stimulation
Individual neuromuscular electrical stimulation training had to be performed twice a day (morning and evening) over the whole duration of the intervention phase (60 days). Subjects were asked to continuously increase the intensity until a maximum intensity of 100mA per training.
DEVICEHEPHAISTOS unloading orthotic device
Orthotic device which unloads the muscles of the lower leg. Subjects had to wear the device for the whole duration of the intervention phase (60 days).
Sponsors
DLR German Aerospace Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male volunteers * Age: between 20 and 45 years * Body mass index (BMI): 20 -26 kg/m2 * Agreement and signed consent before the study
Exclusion criteria
* Smoker * Competitive Athletes * Diabetes mellitus * Rheumatic disease * Muscle or joint disease * Bone fractures in the period up to one year before study start * Herniated disc * Flatfeet (pes planus) * Allergy to nuts or legume * Vascular diseases * Epilepsy * Severe hyperlipidemia * Anemia (\< Hb standard values; standard values healthy men: 13.5 -17.5 g/dl) \* * Increased thrombosis risk \* * Kidney disorder: deviations from normal values for creatinine in plasma. (Normal value: Creatinine \< 1.20 mg/dl)\* * Lesions of the cruciate ligaments, or orthopedic surgery in the past 10 years on the side of the Hephaistos orthosis * Achilles tendon injury, or rupture in the past 10 years on the side of the orthosis * hyper-/hypocalcaemia (abnormal levels of calcium in the blood, normal level: 2.15 - 2.64 mmol/l) * Intake of anti-inflammatory drugs during the study * Abuse of drugs or alcohol (\> than 20-30g alcohol/day) * Participation in another clinical study within the last 2 months before the start of this study * Increased bleeding tendency (hemophilia, regular use of anticoagulants) * History of intolerance to local anesthetics * Imprisoned during study * Any other condition classed as unsuitable for study participation by the medical executive director * prior convictions (objectionable criminal record) Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Local Glucose Uptake into m. soleus | Baseline to day 59 of the intervention phase | Biopsies were taken from m. soleus |
| Changes in Local Glucose Metabolism in m. soleus | Baseline to day 60 of the intervention phase | Microdialysis was performed in m. soleus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood HbA1c (changes in the whole body glucose metabolism) | Baseline and day 2 & 1 before the intervention phase, day 4, 14, 28, 42 & 60 of the intervention phase and day 2 & 14 after the intervention phase | — |
| Blood Fructosamine (changes in the whole body glucose metabolism) | Baseline and day 2 & 1 before the intervention phase, day 4, 14, 28, 42 & 60 of the intervention phase and day 2 & 14 after the intervention phase | — |
| Insulin Sensitivity (changes in the whole body glucose metabolism) | Baseline and day 60 of the intervention phase | Whole body insulin sensitivity assessed by hyperinsulinemic euglycemic clamp |
| Changes in Muscle Volume | Baseline to day 58 of the intervention phase | Muscle volume measured by magnetic resonance imaging (MRI) |
| Blood Glucose (changes in the whole body glucose metabolism) | Baseline and day 2 & 1 before the intervention phase, day 4, 14, 28, 42 & 60 of the intervention phase and day 2 & 14 after the intervention phase | — |
| Changes in Muscle Function (MVC) | Baseline to day 58 of the intervention phase | Maximal voluntary contractions (MVC) - isometric and isokinetic - were performed |
| Compliance | During 60 days of intervention | Electronic wearing time devices from Orthotimer were used to assess compliance of the subjects. |
| Movement | During 60 days of intervention and during 14 days of the recovery phase (post intervention phase) | Accelerometers were used to assess movement of the subjects. |
| Changes in Muscle Function (jump performance) | Baseline to day 58 of the intervention phase | A jump test was performed |
| Blood C-Peptide (changes in the whole body glucose metabolism) | Baseline and day 2 & 1 before the intervention phase, day 4, 14, 28, 42 & 60 of the intervention phase and day 2 & 14 after the intervention phase | — |
Outcome results
None listed