50 Participants Needed

Bed Rest for Type 2 Diabetes and Skeletal Muscle Atrophy in Older Adults

(REST Trial)

RD
Overseen ByRecruitment Department
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida
Must be taking: DPP-4 inhibitors, Sulfonylureas, Metformin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to determine the impact of pre-diabetes and type 2 diabetes on muscle atrophy during a period of bed rest and recovery of muscle mass, strength, and physical function following bed rest.

Who Is on the Research Team?

PC

Paul Coen, PhD

Principal Investigator

Translational Research Institute for Metabolism and Diabetes

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to follow the study's rules, including taking the study product, staying active as advised, and filling out forms.
My kidney function is good, with an eGFR over 45.
I have signed all required consent and privacy forms for the study.
See 4 more

Exclusion 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.
See 31 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Bed Rest

Participants undergo 10 days of strict bed rest with muscle biopsies collected to determine mitochondrial function and lipid profile

10 days

Ambulatory Recovery

Participants undergo 4 weeks of ambulatory recovery to assess recovery of muscle mass, strength, and physical function

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the recovery period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bed rest
Trial Overview 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.
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials
41
Recruited
3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials
51
Recruited
5,900+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security