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Exercise Program for Type 2 Diabetes in Older Adults (RECOVER Trial)

N/A

Waitlist Available

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 has pre-diabetes or has been diagnosed with type 2 diabetes and taking 0-3 oral hypoglycemic agents, which include DPP-4 inhibitors, Sulfonylureas and/or Metformin therapy, and has an Hgb A1C < 8.0%.

Must not have

Concomitant medications with known contraindication or interaction with low-molecular weight heparin (including anti-platelet agents, anti-coagulant agents, non-steroidal anti-inflammatory drugs)

Participant has hypothyroidism (TSH less than or equal to (0.5mIU/L) or hyperthyroidism TSH greater than or equal to 10mIU/L.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mmediately following bed rest, and following the exercise or non-exercise recovery phase

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well exercise can help people with pre-diabetes and type 2 diabetes recover from bedrest.

Who is the study for?

This trial is for men and women aged 60-80 with pre-diabetes or type 2 diabetes, managed with up to three oral medications and an Hgb A1C < 8.0%. They must have stable cholesterol levels, normal kidney function, be willing to follow the study protocol, and not have had recent major surgery or hospitalization. Exclusions include severe health conditions like active cancer, uncontrolled hypertension, significant heart issues within the last six months, mental impairment (mini-Mental State Examination score < 21), allergies to certain medications including heparin and lidocaine.

What is being tested?

The study investigates how an exercise program can aid muscle recovery after a period of bed rest in older adults with pre-diabetes or type 2 diabetes. Participants will undergo a bed rest intervention followed by prescribed exercises to see if this improves their muscle mass, strength, and physical function.

What are the potential side effects?

While specific side effects are not detailed for this trial as it focuses on exercise training following bed rest rather than drug interventions; general risks may include muscle soreness or strain from exercising.

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 have pre-diabetes or type 2 diabetes, take up to 3 diabetes pills, and my Hgb A1C is below 8%.

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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 am not taking any medication that interacts with blood thinners.

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My thyroid is underactive (TSH ≤ 0.5) or overactive (TSH ≥ 10).

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I have a serious gastrointestinal condition.

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I have a chronic infectious disease like TB, Hepatitis B/C, or HIV.

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I was hospitalized for more than 2 days due to surgery last month.

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My mental state score is below 21.

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I have had bleeding in my brain or digestive system.

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I have had a stroke or cerebrovascular accident in the past.

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I have an active cancer or autoimmune disease.

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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 currently experiencing severe, uncontrolled diarrhea, nausea, or vomiting.

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I have type 1 diabetes.

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I have had pressure ulcers in the past.

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I haven't taken steroids or been treated for an infection in the last 3 months.

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My blood pressure is not between 100/60 and 150/95.

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I experience leg cramps or have trouble walking due to pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following bed rest, and following the exercise or non-exercise recovery phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following bed rest, and following the exercise or non-exercise recovery phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following bed rest, and following the exercise or non-exercise recovery phase 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: Non-Exercise RecoveryExperimental Treatment1 Intervention

Older males and females with pre-diabetes or type 2 diabetes. Participants in the ambulatory recovery group will not receive any exercise intervention or advice on exercise following 10 days of bed rest. Rather these participants will return to their regular daily routine that they engaged in prior to the bed rest intervention.

Group II: Exercise RecoveryExperimental Treatment2 Interventions

Older males and females with pre-diabetes or type 2 diabetes. We are examining the effects of a recovery exercise program for older adults with pre-diabetes and type 2 diabetes. Following 10 days of bed rest and during the first 4 weeks of recovery, participants will perform a combination of aerobic and resistance exercise training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Program

2016

Completed Phase 4

~5010

0 / 19Eligibility criteria met