Exercise Training as an Intervention to Improve Muscle Function and Recovery Following Bed Rest i… (NCT04057677) | Clinical Trial Compass
TerminatedNot Applicable
Exercise Training as an Intervention to Improve Muscle Function and Recovery Following Bed Rest in Older Adults With Type 2 Diabetes
Stopped: Insufficient funds.
United States12 participantsStarted 2019-12-20
Plain-language summary
The purpose of this research is to gather data on how exercise can help recovery of muscle mass, strength, and physical function after bedrest in older adults with pre-diabetes and type 2 diabetes.
Who can participate
Age range60 Years – 80 Years
SexALL
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Inclusion criteria
✓. Participant must be male or female, ages 60 through 80 years of age.
✓. 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%.
✓. Participants on Insulin, injectable incretin mimetics, SGLT2 inhibitors, and Thiazolidinediones will be excluded.
✓. Pre-Diabetics are defined as having an HgbA1c of greater than or equal to 5.7% and less 6.5%, or a fasting glucose of greater than or equal to 100 mg/dl and less than 126 mg/dl or has a glucose of greater than or equal to 140 mg/dl and less than 200mg/dl at the 2 hour blood draw during OGTT
✓. Participant must have renal function with an estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73m2 determined at screening.
✓. Participant's triglyceride level is \< 350 mg/dl and LDL cholesterol is ≤ 150 mg/dl at screening.
✓. Participant states willingness to follow protocol as described, the prescribed activity level and completing any forms needed throughout the study.
✓. Participant has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
Exclusion criteria
✕. Participant has type 1 Diabetes.
What they're measuring
1
Leg Lean Mass
Timeframe: Immediately following bed rest, and following the exercise or non-exercise recovery phase
2
Mitochondrial Respiration
Timeframe: mmediately following bed rest, and following the exercise or non-exercise recovery phase
Trial details
NCT IDNCT04057677
SponsorAdventHealth Translational Research Institute
✕. Participant is actively pursuing weight loss and/or lifestyle changes.
✕. Participant has a history of pressure ulcers.
✕. Participant has a stated history of Deep Vein Thrombosis (DVT), pulmonary embolism, or a known hypercoagulable condition, or other clotting or bleeding disorders.
✕. History of gastrointestinal or intracranial hemorrhage.
✕. History of stroke or cerebrovascular accident.
✕. Recent history of major trauma (within 3 months).