Unloading Induced Effects on Local Glucose Uptake Into m. Soleus

NCT02698878 | Completed

• 1 other identifier: NHP
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Local Glucose Uptake; Glucose Metabolism Disorders

Keywords

Lupin Protein; Glucose Metabolism; GLUT4; Muscle Unloading; Neuromuscular Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• Changes in Local Glucose Uptake into m. soleus

  Biopsies were taken from m. soleus

  Baseline to day 59 of the intervention phase

• Changes in Local Glucose Metabolism in m. soleus

  Microdialysis was performed in m. soleus

  Baseline to day 60 of the intervention phase

Secondary Outcomes (10)

• 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

• 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

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Control Group consisting of six healthy male subjects wearing only the HEPHAISTOS ORTHOSIS for lower leg unloading (60 days).

Device: HEPHAISTOS unloading orthotic device

Intervention Group

EXPERIMENTAL

Intervention group consisting of seven healthy mal subjects, wearing the HEPHAISTOS orthosis for lower leg unloading (60 days), plus receiving lupin protein every day and performing a neuromuscular electrical stimulation training twice a day.

Dietary Supplement: lupin protein; Other: Neuromuscular electrical stimulation; Device: HEPHAISTOS unloading orthotic device

Interventions

lupin protein DIETARY_SUPPLEMENT

19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)

Intervention Group

Neuromuscular electrical stimulation OTHER

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.

Also known as: NMES

Intervention Group

HEPHAISTOS unloading orthotic device 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).

Also known as: HEP

Control Group; Intervention Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male volunteers
• Age: between 20 and 45 years
• Body mass index (BMI): 20 -26 kg/m2
• Agreement and signed consent before the study

You may not qualify if:

• 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)\*

Sponsors & Collaborators

• DLR German Aerospace Center: lead

Related Publications (1)

• Zange J, Schopen K, Albracht K, Gerlach DA, Frings-Meuthen P, Maffiuletti NA, Bloch W, Rittweger J. Using the Hephaistos orthotic device to study countermeasure effectiveness of neuromuscular electrical stimulation and dietary lupin protein supplementation, a randomised controlled trial. PLoS One. 2017 Feb 16;12(2):e0171562. doi: 10.1371/journal.pone.0171562. eCollection 2017.

  PMID: 28207840 DERIVED

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jörn Rittweger, Prof. Dr.

  DLR German Aerospace Center

  STUDY DIRECTOR

• Kathrin Schopen, M.Sc.

  DLR German Aerospace Center

  PRINCIPAL INVESTIGATOR

• Petra Frings-Meuthen, Dr.

  DLR German Aerospace Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 4, 2016
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 8, 2016

Record last verified: 2016-03