Unloading Induced Effects on Local Glucose Uptake Into m. Soleus

Glucose Metabolism Disorders Clinical Trial

— NutriHEP  

Official title:

Effects of Nutrition and Neuromuscular Electrical Stimulation on Local Glucose Uptake Into m. Soleus During 60 Days of Lower Leg Unloading

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698878
• Other study ID #: NHP
• Status: Completed
• Phase: N/A
• First received: February 23, 2016
• Last updated: March 7, 2016
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: March 2016
• Source: DLR German Aerospace Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Exclusion Criteria for MRI

• Metal implants or other osteosynthesis material

• Pacemaker

• Claustrophobia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Local Glucose Uptake
• Metabolic Diseases

Intervention

Dietary Supplement:
• lupin protein
19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)

Other:
• Neuromuscular 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.

Device:
• HEPHAISTOS 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DLR German Aerospace Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Local Glucose Uptake into m. soleus	Biopsies were taken from m. soleus	Baseline to day 59 of the intervention phase	No
Primary	Changes in Local Glucose Metabolism in m. soleus	Microdialysis was performed in m. soleus	Baseline to day 60 of the intervention phase	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Insulin Sensitivity (changes in the whole body glucose metabolism)	Whole body insulin sensitivity assessed by hyperinsulinemic euglycemic clamp	Baseline and day 60 of the intervention phase	No
Secondary	Changes in Muscle Volume	Muscle volume measured by magnetic resonance imaging (MRI)	Baseline to day 58 of the intervention phase	No
Secondary	Changes in Muscle Function (jump performance)	A jump test was performed	Baseline to day 58 of the intervention phase	No
Secondary	Changes in Muscle Function (MVC)	Maximal voluntary contractions (MVC) - isometric and isokinetic - were performed	Baseline to day 58 of the intervention phase	No
Secondary	Compliance	Electronic wearing time devices from Orthotimer were used to assess compliance of the subjects.	During 60 days of intervention	No
Secondary	Movement	Accelerometers were used to assess movement of the subjects.	During 60 days of intervention and during 14 days of the recovery phase (post intervention phase)	No