Actively Recruiting
The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults
Led by AdventHealth Translational Research Institute · Updated on 2025-03-13
50
Participants Needed
1
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 60 and 80 years old
- Have pre-diabetes or type 2 diabetes treated only with DPP-4 inhibitors, Sulfonylureas, or Metformin and have an A1C below 8.0
- Pre-diabetics defined by specific blood sugar levels or A1C between 5.7% and 6.5%
- Non-diabetic control group defined by A1C below 5.7% and normal glucose levels during testing
- Estimated kidney function (eGFR) above 45 ml/min/1.73m2
- Triglyceride level below 350 mg/dl and LDL cholesterol at or below 150 mg/dl
- Non-smokers who have not used tobacco, nicotine, or vaporizers within 3 months prior to screening
- Willingness to follow the study protocol including taking study products and completing forms
- Signed informed consent and authorization prior to participation
You will not qualify if you...
- Have type 1 diabetes
- Body mass index over 40 kg/m2
- Actively trying to lose weight or make lifestyle changes
- History of pressure ulcers
- History of blood clots, clotting disorders, or deep vein thrombosis
- History of gastrointestinal or brain bleeding
- History of stroke or other cerebrovascular accidents
- Major trauma within the last 3 months
- Low platelet count or high potassium levels on screening labs
- Untreated or poorly controlled high blood pressure or low blood pressure
- High thyroid stimulating hormone (TSH) level of 10 mIU/L or above
- Current infection requiring medication or recent corticosteroid treatment (except inhaled or topical) within 3 months
- Use of anti-inflammatory medications within 1 week prior to screening
- Recent surgery requiring hospitalization for more than 2 days within 1 month
- Active cancer or autoimmune disease
- Significant liver problems or very high liver enzyme levels
- Chronic contagious infections like tuberculosis, Hepatitis B or C, or HIV
- Amputation or use of artificial limbs
- Significant cardiovascular events or heart failure within 6 months
- Severe uncontrolled digestive symptoms
- Serious gastrointestinal diseases or history of bariatric surgery
- Inability to abstain from alcohol during bed rest and limited alcohol intake during recovery
- Use of medications or supplements affecting glucose metabolism, weight, or blood clotting
- Mini-Mental State Examination score below 21
- Contraindications to MRI such as metal implants or claustrophobia
- Inability to undergo MRI or DEXA scans due to physical limitations
- Allergy or sensitivity to lidocaine, heparin, pork products, or related medications
- History of heparin-induced thrombocytopenia
- Low hemoglobin levels or signs of anemia
- Use of medications that interact with low molecular weight heparin
- Any condition compromising safety, data integrity, or study completion ability
- Symptoms of leg cramping or difficulty walking due to claudication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Actively Recruiting
Research Team
R
Recruitment Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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