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N/A

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
Must not have
Participant has an active malignancy or autoimmune disease
Participant experiences symptoms of claudication. Symptoms include cramping pain in the legs and/or difficulty walking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre and post bed rest and following 4 weeks of ambulatory recovery
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good, with an eGFR over 45.
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I am between 60 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active cancer or autoimmune disease.
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I experience leg cramps or trouble walking due to pain.
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I was hospitalized for more than 2 days due to surgery last month.
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My blood pressure is not between 100/60 and 150/95.
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I have a history of blood clots or a condition that makes my blood clot more easily.
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I am not taking any medication that interacts with blood thinners.
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I have had bleeding in my brain or digestive system.
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I have had a stroke in the past.
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I have a serious gastrointestinal condition.
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I do not have chronic contagious diseases like TB, Hepatitis B/C, or HIV.
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I currently suffer from, or have a history of severe uncontrolled diarrhea, nausea, or vomiting.
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I am allergic to pork or certain medications.
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My mental state score is below 21.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre and post bed rest
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre and post bed rest for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Leg Lean Mass
Mitochondrial Respiration
Secondary study objectives
Insulin Sensitivity
Physical function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,614 Total Patients Enrolled
AdventHealth Translational Research InstituteLead Sponsor
50 Previous Clinical Trials
5,914 Total Patients Enrolled
Paul Coen, PhDPrincipal InvestigatorTranslational Research Institute for Metabolism and Diabetes
5 Previous Clinical Trials
141 Total Patients Enrolled

Media Library

Bed rest (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT03761446 — N/A
Type 2 Diabetes Research Study Groups: Older adults without pre-diabetes or Type 2 Diabetes, Older adults with pre-diabetes or type 2 Diabetes
Type 2 Diabetes Clinical Trial 2023: Bed rest Highlights & Side Effects. Trial Name: NCT03761446 — N/A
Bed rest (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03761446 — N/A
~0 spots leftby Dec 2024
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