CLINICAL TRIAL

Bed rest for Muscular Atrophy

Recruiting · 65+ · All Sexes · Orlando, FL

This study is evaluating whether type 2 diabetes has an impact on muscle atrophy during a period of bed rest.

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About the trial for Muscular Atrophy

Eligible Conditions
Pre-diabetes · Prediabetic State · Type 2 Diabetes Mellitus · Diabetes Mellitus · Atrophy · Muscular Atrophy · Diabetes Mellitus, Type 2 · Aging · Wasting;Muscle(S) · Sedentary Behaviors

Treatment Groups

This trial involves 4 different treatments. Bed Rest is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Bed rest
BEHAVIORAL
Experimental Group 2
Bed rest
BEHAVIORAL
Experimental Group 3
Bed rest
BEHAVIORAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bed rest
2006
N/A
~340

Eligibility

This trial is for patients born any sex aged 65 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The participant has pre-diabetes or type 2 diabetes and is only taking DPP-4 inhibitors, Sulfonylureas and/or Metformin therapy show original
The participant says that they will follow the protocol as described, including consuming the study product as prescribed, behaving in the prescribed manner and completing any necessary forms. show original
The participant has agreed to take part in the study and has signed an informed consent form which has been approved by an institutional review board show original
The participant has a triglyceride level of less than 350mg/dl and an LDL cholesterol level of less than 150mg/dl at screening. show original
People who want to participate in the study must not smoke tobacco, use nicotine products, vape pens, or vaporizers in the three months before screening. show original
People between the ages of 65 and 80 who want to participate in the study must be either male or female. show original
Pre-Diabetics are defined as having an HgbA1c of greater than or equal to 5.7% and less 6.5%, or a fasting glucose of greater than or equal to 100 mg/dl and less than 126 mg/dl or has a glucose of greater than or equal to 140 mg/dl and less than 200mg/dl at the 2 hour blood draw during OGTT
Non-diabetic controls have an HgbA1c of less than 5.7%, a fasting glucose of less than 100 mg/dl, and a glucose level less than 140 mg/dl during an OGTT. show original
The participant must have renal function with an estimated glomerular filtration rate (eGFR) of greater than or equal to 45 ml/min/1.73m2 at screening. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Pre and Post Bed Rest
Screening: ~3 weeks
Treatment: Varies
Reporting: Pre and Post Bed Rest
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Pre and Post Bed Rest.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Bed rest will improve 2 primary outcomes and 2 secondary outcomes in patients with Muscular Atrophy. Measurement will happen over the course of Pre and Post Bed Rest.

Physical function
PRE AND POST BED REST
Determined by short physical performance battery
PRE AND POST BED REST
Leg Lean Mass
PRE AND POST BED REST AND FOLLOWING 4 WEEKS OF AMBULATORY RECOVERY
Determined by DXA (dual energy x-ray absorptiometry)
PRE AND POST BED REST AND FOLLOWING 4 WEEKS OF AMBULATORY RECOVERY
Insulin Sensitivity
PRE AND POST BED REST
Determined by hyperinsulinemic euglycemic glucose clamp
PRE AND POST BED REST
Mitochondrial Respiration
PRE AND POST BED REST
Determined by high resolution respirometry in permeabilized muscle fiber bundles
PRE AND POST BED REST

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of muscular atrophy?

Muscle atrophy in endurance-trained individuals is associated with low muscle oxidative enzyme activities, inversely proportional to an increase in enzyme activities correlating to strength and endurance. Muscle atrophy in endurance-trained individuals appears to be reversible and related to changes in the oxidative metabolism and exercise capacity in the trained state.

Anonymous Patient Answer

How many people get muscular atrophy a year in the United States?

Around 60,000 girls and boys annually die prematurely on their birthday because of muscular atrophy. Muscle atrophy is the cause of around 65% of all childhood deaths.

Anonymous Patient Answer

What causes muscular atrophy?

Despite the enormous progress made in research of muscular dystrehs, the causes of muscular dystrophy remain largely unknown. Muscular dystrophies are a consequence of a lack or imbalance in the cellular signalling pathways of signalling cells within the muscle. Muscle cells are able to communicate with one another via gap junctions so the loss of cell signalling may be a component of, and perhaps the fundamental mechanism underlying, muscular degeneration.

Anonymous Patient Answer

What are common treatments for muscular atrophy?

This review confirms a shortage of proven effective treatments. Although many potential treatments were described, no conclusive evidence has shown any of them to be effective in treating a wasting disorder. The situation is similar for muscular dystrophies. In a recent study, findings imply that effective treatment may be more difficult to develop than anticipated.

Anonymous Patient Answer

What is muscular atrophy?

Muscle atrophy is a common symptom of various forms of muscle wasting, and typically occurs before muscle mass is decreased on the basis of muscle size alone. Muscle atrophy is often accompanied by fatigue and low energy levels. Larger prospective studies are needed to understand the epidemiology, mechanism and consequences of muscle atrophy.

Anonymous Patient Answer

Can muscular atrophy be cured?

Muscular atrophy is an entity separate from sarcopenia, but patients usually recover some of their muscle mass when treatments are instituted. In addition to conventional therapeutic protocols, our own treatment protocol, a combination of protein-energy intake and regular exercise, can greatly improve the overall muscle mass, strength, and quality of life.

Anonymous Patient Answer

What is the average age someone gets muscular atrophy?

The authors believe that the average age of onset of this condition is age 34. They note that more research is required before the authors can draw a more robust conclusion.\n\nThe use of a variety of medical and non-medical treatments for muscular atrophy have been described. These have included: physical therapy, weight training, stretching/tendon conditioning; medical treatment through various supplements; and use of different anti-obesity drugs. \n\nAlthough there has not been enough studies to draw a definitive conclusion, several studies have examined the effectiveness of medical treatments and therapies. Most have demonstrated a positive reduction in patient symptoms, with some studies indicating that improvements have been maintained in certain patients for several years after stopping medical treatments.

Anonymous Patient Answer

Is bed rest typically used in combination with any other treatments?

There was a significant difference in muscle-specific protein synthesis between the bedrest and physical activity groups. Based on these findings, there was no evidence to show that bedrest had a greater effect on muscle strength than physical activity. The authors concluded that participants may benefit from additional intervention of some sort.

Anonymous Patient Answer

What is the primary cause of muscular atrophy?

These data show that the primary etiological lesion in the absence of an ongoing muscular injury is a localized inflammatory process, which leads to a profound functional and mechanical compromise that is largely reversible.

Anonymous Patient Answer

What is bed rest?

The use of beds has not proved to be a treatment for muscular atrophy of the lower leg regardless of its duration, while prolonged bed rest has been found to be a risk factor for lower-leg muscular atrophy in some studies.

Anonymous Patient Answer

What are the latest developments in bed rest for therapeutic use?

Despite many years of intense research, the benefits or otherwise of BR remain unsettled. While the effectiveness of BR in osteoporosis, edema, and recovery of mobility is still somewhat controversial, the evidence is compelling that patients with chronic, disabling musculoskeletal conditions suffer from substantial disability after BR treatment and/or surgery. There is no doubt that many patients will benefit from a few weeks of recovery on a couch, but many will benefit more from surgical intervention. In our view, many patients will need more prolonged, intensive recovery on an operating or in a rehabilitation setting to regain the functional capability that is lost through BR. This may involve physical therapy, occupational therapy, and/or speech therapists.

Anonymous Patient Answer

Has bed rest proven to be more effective than a placebo?

Data from a recent study suggests a placebo effect as a substantial reason for the higher incidence of atrophy among subjects in the bed rest group. The greater incidence rates observed in the bed rest group suggest the usefulness of a prolonged trial before a formal conclusion can be made regarding the efficacy of bed rest in the prevention of ICF. However, this long-term bed rest trial demonstrates the potential benefits of intensive exercise and activity in elderly men. A randomized trial is warranted to evaluate the extent to which the above beneficial lifestyle recommendations in the absence of exercise could be expected to confer a similar or enhanced benefit.

Anonymous Patient Answer
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