Bed Rest for Type 2 Diabetes and Skeletal Muscle Atrophy in Older Adults
(REST Trial)

Recruiting in Palo Alto (17 mi)

Overseen byPaul Coen, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

+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.

+31 more

Trial Timeline

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

Participant Groups

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.

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