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Bed rest for Sarcopenia
N/A
Waitlist Available
Led By Elena Volpi, MD, PhD
Research Sponsored by The University of Texas Medical Branch, Galveston
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 change from baseline to up to 3 months
Awards & highlights
Study Summary
This trial will test if a new drug can help improve muscle loss and disability in older adults with type 2 diabetes.
Eligible Conditions
- Sarcopenia
- Diabetes
- Aging
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amino acid transporter expression
Secondary outcome measures
Knee extension strength
Leg lean mass
Muscle protein synthesis
Trial Design
7Treatment groups
Experimental Treatment
Group I: RT in T2DMExperimental Treatment1 Intervention
Type 2 diabetes subjects will undergo 3 months of resistance exercise training. Muscle size, strength and response to a low dose amino acids will be measured before and after training. Results of this arm will be compared to those previously obtained in healthy older subjects who participated in NCT02999802 (same training protocol) after 1:1 matching for age and sex.
Group II: BR in healthy subjects, PTExperimental Treatment2 Interventions
Healthy subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.
Group III: BR in healthy subjects, LAAExperimental Treatment1 Intervention
Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.
Group IV: BR in healthy subjects, HAAExperimental Treatment1 Intervention
Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.
Group V: BR in T2DM, PTExperimental Treatment2 Interventions
Type 2 diabetes (T2DM) subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.
Group VI: BR in T2DM, LAAExperimental Treatment1 Intervention
Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest.
Group VII: BR in T2DM, HAAExperimental Treatment1 Intervention
Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resistance exercise training
2016
Completed Phase 3
~800
Bed rest
2006
N/A
~430
Intensive physical therapy
2020
N/A
~120
Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
243 Previous Clinical Trials
56,576 Total Patients Enrolled
9 Trials studying Sarcopenia
661 Patients Enrolled for Sarcopenia
National Institute on Aging (NIA)NIH
1,676 Previous Clinical Trials
28,021,404 Total Patients Enrolled
24 Trials studying Sarcopenia
1,503 Patients Enrolled for Sarcopenia
Elena Volpi, MD, PhDPrincipal InvestigatorUTMB
6 Previous Clinical Trials
2,717 Total Patients Enrolled
2 Trials studying Sarcopenia
188 Patients Enrolled for Sarcopenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of alcohol or drug abuse.Your weight has stayed the same for at least 3 months.You do not have diabetes or have type 2 diabetes.You currently have cancer or an infection that is not under control.You need to exercise at least two times a week or take at least 10,000 steps every day.You have a serious health condition related to your heart, liver, kidneys, blood, or breathing.You have difficulty with basic everyday tasks.You fall more than twice in a year.You have lost more than 5% of your body weight in the last 6 months.Your body mass index (BMI) is less than 40 kg/m².You have taken anabolic steroids, corticosteroids, or estrogen in the past three months.You score 26 or higher on a test that checks your memory and thinking skills.
Research Study Groups:
This trial has the following groups:- Group 1: RT in T2DM
- Group 2: BR in healthy subjects, LAA
- Group 3: BR in healthy subjects, HAA
- Group 4: BR in T2DM, LAA
- Group 5: BR in T2DM, HAA
- Group 6: BR in healthy subjects, PT
- Group 7: BR in T2DM, PT
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.
Sarcopenia Patient Testimony for trial: Trial Name: NCT03118050 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots for this research project?
"As of 8/16/2022, this study is still actively recruiting participants. It was first posted on 5/28/2017."
Answered by AI
Who would be a good candidate to enroll in this clinical trial?
"Up to 102 elderly individuals with sarcopenia may be enrolled in this study, provided they are between 60 and 80 years old. Other inclusion criteria for potential participants include: a score of 26 or higher on the 30-item Mini Mental State Examination, no recent changes in body weight (i.e. stable weight for at least 3 months), a Body Mass Index lower than 40 kg/sq meter, and either non-diabetic or suffering from Type 2 diabetes Mellitus."
Answered by AI
Are individuals over the age of 30 allowed to participate in this experiment?
"This study is recruiting patients that are at least 60 years old but not older than 80."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Sealy Center on Aging, University of Texas Medical Branch
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have done healthy volunteer studies in the past. I did the NASA bed rest study at UTMB.
PatientReceived no prior treatments
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