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Bed Rest for Type 2 Diabetes and Skeletal Muscle Atrophy in Older Adults (REST Trial)
N/A
Recruiting
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
Participant must have renal function with an estimated glomerular filtration rate (eGFR) > 45 ml/min/1.73m2 determined at screening
Participant must be male or female between the ages of 60 and 80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre and post bed rest and following 4 weeks of ambulatory recovery
Awards & highlights
REST Trial Summary
This trial will look at the effect of diabetes on muscle atrophy during periods of bed rest, and during the recovery process afterwards.
Who is the study for?
This trial is for non-smoking adults aged 60-80 with pre-diabetes or type 2 diabetes managed without insulin. They must have acceptable cholesterol and kidney function levels, be willing to follow the study protocol, and not have a history of major health issues like heart disease, uncontrolled hypertension, or active infections.Check my eligibility
What is being tested?
The study examines how bed rest affects muscle loss and recovery in older adults with pre-diabetes or type 2 diabetes. It aims to understand the impact of these conditions on muscle atrophy during inactivity and subsequent rehabilitation.See study design
What are the potential side effects?
Since the intervention involves bed rest rather than medication, side effects are related to physical inactivity such as potential muscle weakness, reduced stamina, joint stiffness or discomfort from prolonged immobility.
REST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good, with an eGFR over 45.
Select...
I am between 60 and 80 years old.
REST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre and post bed rest
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre and post bed rest
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Leg Lean Mass
Mitochondrial Respiration
Secondary outcome measures
Insulin Sensitivity
Physical function
REST Trial Design
2Treatment groups
Experimental Treatment
Group I: Older adults without pre-diabetes or Type 2 DiabetesExperimental Treatment1 Intervention
Male and female older adults between the ages 60-80 without pre-diabetes or type 2 diabetes
Group II: Older adults with pre-diabetes or type 2 DiabetesExperimental Treatment1 Intervention
Male and female older adults between the ages 60-80 with pre-diabetes or type 2 diabetes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bed rest
2006
N/A
~430
Find a Location
Who is running the clinical trial?
Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,547 Total Patients Enrolled
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
20,131 Total Patients Enrolled
Paul Coen, PhDPrincipal InvestigatorTranslational Research Institute for Metabolism and Diabetes
5 Previous Clinical Trials
141 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot drink alcohol before going to bed during the study, and during the recovery part, you can only have a small amount of alcohol each day.I have an active cancer or autoimmune disease.My liver function is not significantly impaired, except for mild fatty liver.I am willing to follow the study's rules, including taking the study product, staying active as advised, and filling out forms.I can't undergo MRI or DEXA scans due to equipment limits or claustrophobia.My hemoglobin is low or I have significant anemia symptoms.I have taken anti-inflammatory medication, like ibuprofen, within the last week.You are allergic to heparin or other similar medications.I experience leg cramps or trouble walking due to pain.I was hospitalized for more than 2 days due to surgery last month.My blood pressure is not between 100/60 and 150/95.Your thyroid-stimulating hormone (TSH) level is 10mIU/L or higher.My kidney function is good, with an eGFR over 45.I have a history of blood clots or a condition that makes my blood clot more easily.I am not taking any medication that interacts with blood thinners.I have signed all required consent and privacy forms for the study.I have not had a major heart event or been diagnosed with heart failure in the last 6 months.I can avoid taking certain medications or supplements that affect blood sugar or weight before and during the study.I have pre-diabetes or type 2 diabetes, take certain medications, and my A1C is below 8.0.You have had pressure ulcers in the past.I have had bleeding in my brain or digestive system.You have metal implants, devices, or metal-containing tattoos that make it unsafe for you to have an MRI.You are allergic to lidocaine.You have had a condition called heparin induced thrombocytopenia in the past.I have had a stroke in the past.You have a body mass index (BMI) higher than 40.You are currently trying to lose weight or make lifestyle changes.I haven't taken steroids or been treated for an infection in the last 3 months.I have a serious gastrointestinal condition.I have not had a major injury in the last 3 months.You have low platelet count or high potassium levels in your blood.I do not have chronic contagious diseases like TB, Hepatitis B/C, or HIV.I currently suffer from, or have a history of severe uncontrolled diarrhea, nausea, or vomiting.You have had an amputation or use a partial or full artificial limb.I am allergic to pork or certain medications.Your triglyceride level is less than 350 mg/dl and your LDL cholesterol is 150 mg/dl or lower when tested before the study.You have type 1 diabetes.I am between 60 and 80 years old.My mental state score is below 21.
Research Study Groups:
This trial has the following groups:- Group 1: Older adults without pre-diabetes or Type 2 Diabetes
- Group 2: Older adults with pre-diabetes or type 2 Diabetes
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.
Are researchers still taking on new participants for this trial?
"The information accessible on clinicaltrials.gov indicates that this trial is actively seeking participants, having initially been posted March 18th 2019 and most recently updated May 24th 2022."
Answered by AI
What characteristics should a candidate possess to be suitable for this clinical trial?
"Candidates who meet the criteria of having type 2 diabetes mellitus, and being between 60-80 years old may be eligible to enroll in this study. Up to 50 participants are needed for completion."
Answered by AI
Does this medical study accept participants aged 20 or over?
"The eligible age range for this trial is between 60 and 80 years old. According to records, there are 246 trials that accept people under 18, and 1602 studies recruiting patients over the seniority of 65."
Answered by AI
What is the current capacity of this research project?
"Affirmative, the information hosted on clinicaltrials.gov indicates that this medical trial is currently seeking patients to participate. This research was originally posted on March 18th 2019 and last updated on May 24th 2022. 50 individuals are required at 1 particular site."
Answered by AI
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