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Electrical Stimulation for Sarcopenia (microG Trial)
N/A
Waitlist Available
Led By Paul Coen, PhD
Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 30 minutes
Awards & highlights
microG Trial Summary
This trialwill study how muscle changes in zero gravity to understand the health benefits of exercise. Tests measure body composition, strength, and aerobic fitness, and muscle cells are sent to the ISS for research.
Who is the study for?
This trial is for healthy adults aged 20-40 or 60-80 with a BMI under 30, able to consent and follow the study protocol. Excluded are those actively changing their lifestyle for weight loss, with severe uncontrolled symptoms like diarrhea, high/low blood pressure, recent surgery or hospitalization, infectious diseases (e.g., HIV), pregnant/lactating women postpartum within 6 weeks, tobacco users in the last three months, diabetics or those with clotting disorders.Check my eligibility
What is being tested?
The study tests how muscle cells from thigh biopsies behave in microgravity aboard the International Space Station. It aims to simulate accelerated aging and understand muscle wasting. Participants undergo body composition scans (DEXA), strength tests (Handgrip test), aerobic fitness assessments (VO2 max test), and provide muscle tissue samples.See study design
What are the potential side effects?
Potential side effects include discomfort at biopsy site on thigh and risks associated with VO2 max testing such as shortness of breath or fatigue during exercise. DEXA scans have minimal risk but involve low-level radiation exposure.
microG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ about 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about 30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Muscle biopsy parameters
microG Trial Design
2Treatment groups
Experimental Treatment
Group I: Young adultsExperimental Treatment2 Interventions
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.
Group II: Older adultsExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,522 Total Patients Enrolled
2 Trials studying Sarcopenia
200 Patients Enrolled for Sarcopenia
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
20,106 Total Patients Enrolled
2 Trials studying Sarcopenia
200 Patients Enrolled for Sarcopenia
Paul Coen, PhDPrincipal InvestigatorStudy Principal Investigator
5 Previous Clinical Trials
116 Total Patients Enrolled
1 Trials studying Sarcopenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of blood clots or a condition that increases my risk for clots.My liver function is significantly impaired, or my liver tests are more than 2.5 times the normal limit.You have had an amputation or use a partial or full artificial limb.I have had a major heart event or have heart failure within the last 6 months.I have an active cancer or autoimmune disease.I am willing to follow the study's rules and complete all required forms.I haven't taken steroids or been treated for an infection in the last 3 months.You weigh less than 30 kilograms for every square meter of your height.I am currently on, or have recently taken, prescription anti-inflammatory medication.You have used tobacco in the past 3 months.I have a serious gastrointestinal condition.You have a history of using drugs or drinking too much alcohol in the last 5 years.I am not pregnant, breastfeeding, or within 6 weeks after giving birth.My kidney function is reduced with an eGFR of 50 ml/min/1.73m2 or less.Your urine test shows a high level of albumin compared to creatinine, which may indicate kidney problems.I have signed the consent form and agreed to share my health information for this study.I have had pressure ulcers in the past.I was hospitalized for more than 2 days due to surgery within the last 3 weeks.Your triglyceride level is high, or your LDL cholesterol level is too high during the initial check-up.I have diabetes or my Hgb A1c level was over 6.5% during screening.I currently suffer from, or have a history of severe uncontrolled diarrhea, nausea, or vomiting.I have a chronic infectious disease like TB, Hepatitis B/C, or HIV.You are currently trying to lose weight or make lifestyle changes.I am between 20-40 or 60-80 years old.I have untreated thyroid issues.
Research Study Groups:
This trial has the following groups:- Group 1: Young adults
- Group 2: Older adults
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor welcoming octogenarians to participate?
"We are welcoming participants aged between 20 and 80 to join this study."
Answered by AI
Are there any vacancies remaining in this clinical research project?
"Currently, this clinical trial is not recruiting subjects. This study was initially posted on January 25th 2019 and made its most recent edits on November 16th 2022. Despite the lack of enrolment for this trial, there are 107 other studies actively welcoming participants at present."
Answered by AI
Could I partake in this investigation?
"The requirements to be accepted into this trial are having sarcopenia and being between the ages of 20 to 80. The recruitment is aiming for a total of 75 patients."
Answered by AI
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