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Official title The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults
ClinicalTrials.gov ID: NCT03761446
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Participant must be male or female between the ages of 60 and 80 years of age.
- Participant has pre-diabetes or type 2 diabetes and is only taking DPP-4 inhibitors, Sulfonylureas and/or Metformin therapy (but not Insulin...
- 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...
- The non-diabetic control group is defined as having an HgbA1c of less than 5.7%, a fasting glucose of less than 100 mg/dl and a glucose level less...
- Participant must have renal function with an estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73m2 determined at screening.
You likely can't join if
- Participant has type 1 Diabetes.
- BMI \> 40.0 kg/m2
- 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...
- History of gastrointestinal or intracranial hemorrhage.
See the full eligibility criteria
Who can join
- Participant must be male or female between the ages of 60 and 80 years of age.
- Participant has pre-diabetes or type 2 diabetes and is only taking DPP-4 inhibitors, Sulfonylureas and/or Metformin therapy (but not Insulin, injectable incretin mimeticsSGL2 inhibitors, and Thiazolidinedione's), and...
- 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...
- The non-diabetic control group is defined as having an HgbA1c of less than 5.7%, a fasting glucose of less than 100 mg/dl and a glucose level less than 140 mg/dl at the 2hr blood draw during the 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.
- Participants must be non-smokers. Non-smokers as defined by not smoking any tobacco or using nicotine-containing products and not using vape pens or vaporizers within 3 months prior to screening.
- Participant states willingness to follow protocol as described, including consumption of study product per protocol, 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...
What rules you out
- Participant has type 1 Diabetes.
- BMI \> 40.0 kg/m2
- 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).
- Thrombocytopenia (of any cause) or hyperkalemia (K \> 5.0) on screening laboratory assay. May repeat lab value per PI discretion.
- Untreated or poorly controlled hypertension (SBP \> 150, DBP \> 95), or hypotension (SBP \<100 DBP \<60)
- Participant has a TSH greater than or equal to 10mIU/L.
- Participant has current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months...
- Participant is currently taking anti-inflammatory medication or has anti-inflammatory medication in the 1 weeks prior to screening (including over the counter formulations; e.g. Aleve, Motrin, ibuprofen, naproxen).
- Participant has had surgery requiring \> 2 days of hospitalization in the last 1 month prior to screening visit.
- Participant has an active malignancy or autoimmune disease.
- Participant has current significantly impaired liver function in the opinion of the study PI (mild asymptomatic fatty liver is acceptable), or hepatic enzyme tests are ≥ 2.5 times normal limit.
- Participant has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Participant is an amputee and/or has presence of partial or full artificial limb.
- Participant has had a significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or participant has evidence of...
- Participant has a history of, or currently has uncontrolled severe diarrhea, nausea or vomiting.
- Participant has an obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease such as stage III or above gastroesophageal reflux disease...
- Participant cannot abstain from alcohol for the pre bed rest and bed rest portion of the study. For the recovery portion of the study the participant must agree to consume no more than 1 glass of wine (4-5 oz) or bottle...
- Participant cannot refrain from taking medications/dietary supplements/herbals or substances that could modulate glucose metabolism (other than oral hypoglycemic medications), or are considered anabolic, or reduce...
- Participant has a mini-Mental State Examination score \< 21.
- people who fulfill any of the contraindications for MRI; examples include metal implants, devices, paramagnetic objects contained within the body and excessive or metal-containing tattoos.
- Unable to participate in MR or DEXA assessments due to physical limitations of equipment tolerances (e.g., MRI bore size and DEXA 450-pound weight limit) claustrophobia, or based on Investigator's judgment at screening.
- Participant has a sensitivity or allergy to lidocaine.
- Participant has a sensitivity or allergy to heparin, enoxaparin, or other low molecular weight heparin.
- History of allergy to pork products or any component of the formulation of low-molecular weight heparin for dosing.
- History of heparin induced thrombocytopenia.
- Hemoglobin \< 10.0 g/dL for females; \< 11.0 g/dL for males; or participant has clinically significant signs/symptoms of anemia in the opinion of the PI or medical provider.
- Concomitant medications with known contraindication or interaction with low-molecular weight heparin (including anti-platelet agents, anti-coagulant agents, non-steroidal anti-inflammatory drugs)
- Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.
- Participant experiences symptoms of claudication. Symptoms include cramping pain in the legs and/or difficulty walking.
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.