| Eligibility |
Inclusion Criteria:
1. Participant must be male or female, ages 60 through 80 years of age.
2. 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%.
1. Participants on Insulin, injectable incretin mimetics, SGLT2 inhibitors, and
Thiazolidinediones will be excluded.
2. 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
3. Participant must have renal function with an estimated glomerular filtration rate
(eGFR) > 45 ml/min/1.73m2 determined at screening.
4. Participant's triglyceride level is < 350 mg/dl and LDL cholesterol is = 150 mg/dl at
screening.
5. Participant states willingness to follow protocol as described, the prescribed
activity level and completing any forms needed throughout the study.
6. 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:
1. Participant has type 1 Diabetes.
2. BMI > 40.0 kg/m2
3. Participant is actively pursuing weight loss and/or lifestyle changes.
4. Participant has a history of pressure ulcers.
5. Participant has a stated history of Deep Vein Thrombosis (DVT), pulmonary embolism, or
a known hypercoagulable condition, or other clotting or bleeding disorders.
6. History of gastrointestinal or intracranial hemorrhage.
7. History of stroke or cerebrovascular accident.
8. Recent history of major trauma (within 3 months).
9. Thrombocytopenia (<100,000/microL) or hyperkalemia (K > 5.2) on screening laboratory
assay. May repeat lab value per PI discretion.
10. Untreated or poorly controlled hypertension (SBP > 150, DBP > 95), or hypotension (SBP
<100 DBP <60)
11. Participant has hypothyroidism (TSH less than or equal to (0.5mIU/L) or
hyperthyroidism TSH greater than or equal to 10mIU/L.
12. 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 prior to screening visit.
13. Participant is currently taking anti-inflammatory medication or has had
anti-inflammatory medication within 1 week prior to screening (including over the
counter formulations; e.g. Aleve, Motrin, ibuprofen, naproxen, low dose asprin).
14. Participant has had surgery requiring > 2 days of hospitalization in the last 1 month
prior to screening visit.
15. Participant has an active malignancy or autoimmune disease.
16. Participant has current significantly impaired liver function in the opinion of the
study Medical Investigator (mild asymptomatic fatty liver is acceptable), or hepatic
enzyme tests are = 2.5 times normal limit.
17. Participant has a chronic, contagious, infectious disease, such as active
tuberculosis, Hepatitis B or C, or HIV, per self-report.
18. Participant is an amputee and/or has presence of partial or full artificial limb.
19. 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 cardiovascular disease assessed during the ECG
at screening. In the event of a positive stress test, participants are referred to
their primary care physician. If the electrocardiogram (ECG) is determined to be a
false positive, participant may be allowed to participate in study after confirmatory
records obtained.
20. Participant currently has uncontrolled severe diarrhea, nausea or vomiting.
21. 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, gastroparesis, peptic ulcer disease,
celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis and bariatric
surgery.
22. 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 ~14gm of alcohol per day (equivalent to ~ 1 glass of wine (4-5 oz 12%
ABV) or ~bottle of beer (12 oz 5% ABV) /day).
23. 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 weight (fat mass), or that may
interact with low-molecular weight heparin or induce hypo- or hyper-coagulable state,
in the opinion of the PI or medical investigator, starting one week prior to Pre-bed
rest phase and over the entire course of the study. These include progestational
agents (except prescribed birth control), steroids, growth hormone, dronabinol,
marijuana, calcium-beta-hydroxy-betamethylbutyrate (CaHMB), free amino acid
supplements and dietary supplements to aid weight loss.
24. Participant has a mini-Mental State Examination score < 21.
25. Subjects 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.
26. 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.
27. Participant has a sensitivity or allergy to lidocaine.
28. Participant has a sensitivity or allergy to heparin, enoxaparin, or other low
molecular weight heparin.
29. History of allergy to pork products.
30. History of heparin-induced thrombocytopenia.
31. 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.
32. Concomitant medications with known contraindication or interaction with low-molecular
weight heparin (including anti-platelet agents, anti-coagulant agents, non-steroidal
anti-inflammatory drugs)
33. 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.
34. Participant experiences symptoms of claudication. Symptoms include cramping pain in
the legs and/or difficulty walking.
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