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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%.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mmediately following bed rest, and following the exercise or non-exercise recovery phase
Awards & highlights
RECOVER Trial 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.Check my eligibility
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.See study design
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.
RECOVER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good, with an eGFR over 45.
Select...
I have pre-diabetes or type 2 diabetes, take up to 3 diabetes pills, and my Hgb A1C is below 8%.
Select...
I am between 60 and 80 years old.
RECOVER Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Leg Lean Mass
Mitochondrial Respiration
Secondary outcome measures
Insulin Sensitivity
Physical function
RECOVER 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 3
~4930
Find a Location
Who is running the clinical trial?
Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,585 Total Patients Enrolled
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
20,169 Total Patients Enrolled
Paul Coen, PhDPrincipal InvestigatorPrincipal Investigator
5 Previous Clinical Trials
179 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medication that interacts with blood thinners.My liver function is significantly impaired, or my liver tests are more than 2.5 times the normal limit.My thyroid is underactive (TSH ≤ 0.5) or overactive (TSH ≥ 10).You must not drink alcohol before and during the study, and after the study, you should not drink more than one glass of wine or one bottle of beer per day.I have a serious gastrointestinal condition.My kidney function is good, with an eGFR over 45.I have pre-diabetes or type 2 diabetes, take up to 3 diabetes pills, and my Hgb A1C is below 8%.Your blood platelet count is lower than 100,000 per microliter, or your potassium level is higher than 5.2.I haven't had a major heart event or heart failure in the last 6 months.My hemoglobin levels are low, or I have significant symptoms of anemia.I have a chronic infectious disease like TB, Hepatitis B/C, or HIV.I have signed the consent form and agreed to share my health information for this study.I was hospitalized for more than 2 days due to surgery last month.I can't undergo MR or DEXA scans due to equipment limits, fear of tight spaces, or the doctor's decision.I can avoid taking certain medications or supplements that affect blood sugar, weight, or blood clotting during the study.My mental state score is below 21.You have had a limb amputated or use an artificial limb.I have had bleeding in my brain or digestive system.I have had a stroke or cerebrovascular accident in the past.I have an active cancer or autoimmune disease.I have a history of blood clots or a condition that makes my blood clot more easily.I am currently experiencing severe, uncontrolled diarrhea, nausea, or vomiting.You have had a condition called heparin-induced thrombocytopenia in the past.I have type 1 diabetes.I have had pressure ulcers in the past.Your body mass index (BMI) is higher than 40.You are currently trying to lose weight or make lifestyle changes.I haven't taken steroids or been treated for an infection in the last 3 months.I have not had a major injury in the last 3 months.My blood pressure is not between 100/60 and 150/95.I experience leg cramps or have trouble walking due to pain.Your triglyceride level is less than 350 mg/dl, and your LDL cholesterol is 150 mg/dl or lower when tested before the study.I am between 60 and 80 years old.You have had an allergic reaction to pork products in the past.I have taken anti-inflammatory medication, including over-the-counter ones, within the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Exercise Recovery
- Group 2: Exercise Recovery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current count of participants in this medical experiment?
"Affirmative. The clinicaltrials.gov website states that this medical experiment, which was published on December 20th 2019, is actively searching for participants. Approximately 50 individuals are needed from one research centre."
Answered by AI
For whom is this experiment the most suitable?
"This medical trial is enrolling 50 individuals aged between 60 and 80 who have been diagnosed with type 2 diabetes. Participants must agree to the protocol, be either male or female, present an HbA1C level of less than 8%, not use insulin injections nor certain other medications, possess renal function of more than 45 ml/min/1.73m2 with triglyceride levels below 350 mg/dl and LDL cholesterol no higher than 150mg/dl as well as sign a consent form approved by their Institutional Review Board and provide HIPAA authorization before being accepted for the study."
Answered by AI
Is there still room for participants in this experiment?
"Affirmative, current information on clinicaltrials.gov suggests that this research trial is still accepting participants. It was originally posted in December of 2019 and last modified in May of 2022; the study aims to recruit 50 subjects from a single site."
Answered by AI
Does this research endeavor accept participants over the age of 60?
"As per the specifications of this medical trial, patients must be above 60 years old and below 80 in order to participate."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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