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Electrical Stimulation of Human Myocytes in Microgravity (microG)

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ClinicalTrials.gov Identifier: NCT03665051
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

Brief Summary:
The purpose of this study is to evaluate the changes of muscle, in microgravity. Which will help explain the health benefits of exercise. There are tests that can be done to tell researchers more about the human body, such as a dual energy x-ray absorptiometry (DEXA) scan, which measures body composition (fat and lean body mass). The use of muscle testing and a Handgrip test can tell us about the strength and power within an individual's muscles. A VO2 max test helps us understand the aerobic fitness level of an individual and one of the most important aspects of this study are muscle cells. A muscle biopsy allows us to obtain muscle cells from the thigh, which will be sent into space by a rocket. Researchers will study these muscle cells in a low gravity environment aboard the International Space Station. Studying the muscle cells under those conditions will potentially mimic an accelerated aging process, which will help researchers better understand muscle wasting in the elderly.

Condition or disease Intervention/treatment Phase
Sarcopenia Procedure: Muscle Tissue Biopsy Other: Maximal Oxygen Consumption (V02max) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Electrical Stimulation of Human Myocytes in Microgravity: An In Vitro Model to Evaluate Therapeutics to Counteract Muscle Wasting (microG)
Actual Study Start Date : January 25, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Young adults
Obtain muscle biopsy specimens from young adults (ages 20-40) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures.
Procedure: Muscle Tissue Biopsy
A biopsy of the Vastus Lateralis muscle will be performed on the left leg using the Bergstrom technique.The skin will be incised (approximately 0.75 cm) with a #11 scalpel, and the Bergstrom needle will be inserted into the Vastus Lateralis. Approximately 150 mg of muscle tissue will be obtained under suction. After the biopsy, pressure will be applied to stop bleeding and the skin will be closed with Steri strips (suture(s) if allergy to steri strips and removal 7-10 days post biopsy). A sterile dressing will be applied. Ace bandage may also be used along with applied pressure and an ice pack for any swelling and pain relief.

Other: Maximal Oxygen Consumption (V02max)
Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle exercise test. Heart rate, blood pressure and ECG will be recorded throughout this test. Subjects will breathe through a low resistance mouthpiece and wear a nose clip. Expired gases will be measured by indirect calorimetry and heart rate monitored by a portable heart rate monitor. Following a standardized warm up, subjects will begin exercising at a moderate intensity with the workload increased every minute until the subject can no longer continue. A leveling-off (plateau) or decline in oxygen uptake should be demonstrated in order to be reasonably sure that a subject has achieved the maximum capacity for aerobic metabolism.

Older adults
Obtain muscle biopsy specimens from older adults (ages 60-80) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures.
Procedure: Muscle Tissue Biopsy
A biopsy of the Vastus Lateralis muscle will be performed on the left leg using the Bergstrom technique.The skin will be incised (approximately 0.75 cm) with a #11 scalpel, and the Bergstrom needle will be inserted into the Vastus Lateralis. Approximately 150 mg of muscle tissue will be obtained under suction. After the biopsy, pressure will be applied to stop bleeding and the skin will be closed with Steri strips (suture(s) if allergy to steri strips and removal 7-10 days post biopsy). A sterile dressing will be applied. Ace bandage may also be used along with applied pressure and an ice pack for any swelling and pain relief.

Other: Maximal Oxygen Consumption (V02max)
Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle exercise test. Heart rate, blood pressure and ECG will be recorded throughout this test. Subjects will breathe through a low resistance mouthpiece and wear a nose clip. Expired gases will be measured by indirect calorimetry and heart rate monitored by a portable heart rate monitor. Following a standardized warm up, subjects will begin exercising at a moderate intensity with the workload increased every minute until the subject can no longer continue. A leveling-off (plateau) or decline in oxygen uptake should be demonstrated in order to be reasonably sure that a subject has achieved the maximum capacity for aerobic metabolism.




Primary Outcome Measures :
  1. Muscle biopsy parameters [ Time Frame: About 30 minutes ]
    Collection of the muscle biopsy parameters (isolated satellite cells), from 9 participants in each of young and old study groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is capable of giving informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
  • Participant is 20-40 or 60-80 years of age, inclusive
  • Participant BMI <30 kg/m2
  • Participant states willingness to follow protocol as described, including the prescribed activity level and completing any forms needed throughout the study.

Exclusion Criteria:

  • Participant reports a history of type 1 or type 2 Diabetes; or Hgb A1c > 6.5% at screening visit.
  • Participant is actively pursuing weight loss and/or lifestyle changes.
  • Participant has a history of pressure ulcers.
  • Participant has a stated history of Deep Vein Thrombosis (DVT), recent (within last 3 months) pulmonary embolism, or has a positive D-dimer test and lower extremity ultrasound at screening, or a known hypercoagulable condition, or other clotting or bleeding disorders.
  • Participant has poorly controlled hypertension or hypotension in the opinion of the study PI or medical investigator (MI).
  • Participant has untreated hypothyroidism or hyperthyroidism.
  • Participant has current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
  • Participant is currently taking prescription strength anti-inflammatory medication or has taken prescription strength anti-inflammatory medication in the 6 weeks prior to screening.
  • Participant has had surgery requiring >2 days of hospitalization in the last 3 weeks prior to screening visit.
  • Participant has an active malignancy or autoimmune disease.
  • Participant has current significantly impaired liver function in the opinion of the study PI (mild asymptomatic fatty liver is acceptable), or hepatic enzyme tests are ≥2.5 times normal limit.
  • Participant has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV, per self-report.
  • Participant is an amputee and/or has presence of partial or full artificial limb.
  • Participant has had a significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or participant has evidence of cardiovascular disease assessed during the ECG at screening.
  • Participant has a history of, or currently has uncontrolled severe diarrhea, nausea or vomiting.
  • Participant has an obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease such as stage III or above gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
  • Participant has used tobacco within the last 3 months.
  • Participant has a history of drug or alcohol abuse (> 3 drinks per day) within the last 5 years
  • Female participant is pregnant, lactating or is within 6 weeks postpartum prior to the screening visit
  • Participant has impaired renal function: estimated glomerular filtration rate (eGFR) ≤ 50 ml/min/1.73m2 determined at screening.
  • Participant's triglyceride level is ≥ 250 mg/dl and LDL cholesterol is > 150 mg/dl at screening.
  • Participant has a urine albumin-to-creatinine ratio (UACR) ≥300 mg/g at screening in a single urine specimen (per National Kidney Foundation guideline).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665051


Contacts
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Contact: Recruitment Department 407-303-7100 tri@flhosp.org

Locations
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United States, Florida
Translational Research Institute for Metabolism and Diabetes Recruiting
Orlando, Florida, United States, 32804
Contact: Recruitment Department    407-303-7100    tri@flhosp.org   
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Investigators
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Principal Investigator: Paul Coen, PhD Study Principal Investigator
  Study Documents (Full-Text)

Documents provided by Translational Research Institute for Metabolism and Diabetes, Florida:
Informed Consent Form  [PDF] February 20, 2019


Additional Information:
Publications:

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Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT03665051     History of Changes
Other Study ID Numbers: TRIMD 1311789
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms