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

(REST Trial)

Overseen By Recruitment 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

Must not be taking: Insulin, Anti-inflammatories

Disqualifiers: Type 1 diabetes, Obesity, Hypertension, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pre-diabetes and type 2 diabetes affect muscle loss during bed rest and subsequent muscle recovery. Participants will undergo a period of bed rest to assess its impact on muscle mass, strength, and physical function. The study includes two groups: older adults with pre-diabetes or type 2 diabetes and older adults without these conditions. It is ideal for individuals aged 60–80 with pre-diabetes or type 2 diabetes who are not on insulin and are willing to follow study guidelines. As an unphased trial, this study provides a unique opportunity to enhance understanding of muscle health in older adults with and without diabetes.

Will I have to stop taking my current medications?

The trial requires participants to refrain from taking medications, dietary supplements, or substances that could affect glucose metabolism or interact with study drugs, starting one week before enrollment and throughout the study. However, you can continue taking DPP-4 inhibitors, Sulfonylureas, and Metformin if you are already on them.

What prior data suggests that bed rest is safe for older adults?

Research has shown that staying in bed can lead to muscle loss. One study found that just a week of bed rest resulted in losing about 1.4 kg of muscle and a 3.2% decrease in thigh muscle size. Another report indicated that muscle mass can decrease by about 0.5% each day in bed, with strength dropping by 0.3-4.2% daily.

These findings suggest that bed rest weakens and reduces muscle size. This effect is common in both older adults with and without diabetes. While no dangerous side effects are mentioned, the expected muscle changes result from reduced movement. Thus, prolonged bed rest can cause muscles to shrink and lose strength. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are exploring bed rest as a unique approach for managing Type 2 Diabetes and preventing skeletal muscle atrophy in older adults. Unlike typical treatments like medications and lifestyle changes that focus on blood sugar control and exercise for muscle maintenance, this method examines how rest can impact the body differently. They are excited to see if bed rest can offer insights into metabolic changes and muscle preservation, potentially leading to new strategies for managing diabetes and muscle health in older populations.

What evidence suggests that bed rest is effective for studying muscle atrophy in older adults with and without type 2 diabetes?

Research has shown that staying in bed can lead to muscle loss. One study found that just a week of bed rest caused participants to lose about 1.4 kilograms of muscle, including a 3.2% decrease in the size of the quadriceps, the muscles at the front of the thigh. Another study found that even five days of bed rest can significantly reduce leg muscle mass. This trial will examine the effects of bed rest on older adults, with one group consisting of those with pre-diabetes or type 2 diabetes and another group without these conditions. These findings suggest that bed rest can quickly weaken muscles, which is important to consider when evaluating diabetes and muscle health. ^{1 6 7 8 9}

Who Is on the Research Team?

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.

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.

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?

Group I: Older adults without pre-diabetes or Type 2 Diabetes Experimental Treatment 1 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 Diabetes Experimental Treatment 1 Intervention

Male and female older adults between the ages 60-80 with pre-diabetes or type 2 diabetes

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+

Citations

1. researchgate.net researchgate.net/publication/304613690_One_Week_of_Bed_Rest_Leads_to_Substantial_Muscle_Atrophy_and_Induces_Whole-Body_Insulin_Resistance_in_the_Absence_of_Skeletal_Muscle_Lipid_Accumulation

(PDF) One Week of Bed Rest Leads to Substantial Muscle ... Bed rest resulted in 1.4±0.2 kg lean tissue loss and a 3.2±0.9% decline in quadriceps CSA (both P<0.01). VO2peak and 1RM declined by 6.4±2.3 (P< ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article/65/10/2862/35009/One-Week-of-Bed-Rest-Leads-to-Substantial-Muscle

One Week of Bed Rest Leads to Substantial Muscle Atrophy ... Bed rest resulted in 1.4 ± 0.2 kg lean tissue loss and a 3.2 ± 0.9% decline in quadriceps CSA (both P < 0.01).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10829795/

The impact of bed rest on human skeletal muscle metabolism Long-term bed rest did not further increase intracellular glycogen compared to short-term bed rest, due to decreased whole-body insulin ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27358494/

One Week of Bed Rest Leads to Substantial Muscle ... Bed rest resulted in 1.4 ± 0.2 kg lean tissue loss and a 3.2 ± 0.9% decline in quadriceps CSA (both P < 0.01).

5. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/10.14814/phy2.16166

Five days of bed rest in young and old adults: Retainment of ... Five days of bed rest led to significant reductions in whole-leg muscle mass in the control limbs (i.e., non-stimulated legs) of both young and ...

6. clinicaltrial.be clinicaltrial.be/en/details/66196?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

The Role of Type 2 Diabetes on Skeletal Muscle Atrophy an... Older adults with and without pre-diabetes/type 2 diabetes will complete 10 days of strict bed rest followed by 4 weeks of ambulatory recovery.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02109380

Bed-rest, Muscle Mass and Insulin Sensitivity It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

8. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2021.676501/full

Substantial and Reproducible Individual Variability in ... These data suggest that the magnitude of muscle atrophy for a particular individual after a bed rest intervention could be predicted quite ...

9. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/full/10.1113/JP286065

Daily blood flow restriction does not preserve muscle mass ... Bed rest has been shown to reduce skeletal muscle mass by ∼0.5% per day, with a concomitant decline in strength of ∼0.3–4.2% per day (Wall & van ...