The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults



Status:Recruiting
Conditions:Neurology, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:65 - 80
Updated:2/17/2019
Start Date:February 2019
End Date:May 2023
Contact:Recruitment Department
Email:tri@flhosp.org
Phone:407-303-7100

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To gather data on the impact of type 2 diabetes on muscle mass atrophy during a period of bed
rest and recovery of muscle mass, strength, and physical function following bed rest.


Inclusion Criteria:

1. Participant is a male or a non-pregnant, non-lactating female, at least 6 weeks
postpartum prior to screening visit.

2. Participant is 65 to 80 years of age.

3. Participant has type 2 diabetes and is only taking (dipeptidyl-peptidase) DPP-4
inhibitors, Sulfonylureas and/or Metformin therapy (but not Insulin, injectable
incretin mimetics and Thiazolidinedione's), and has an A1C < 7.5%.

4. Participant has normal renal function: estimated glomerular filtration rate (eGFR) >
50 ml/min/1.73m2 determined at screening.

5. Participant's triglyceride level is < 250 mg/dl and LDL cholesterol is ≤ 150 mg/dl at
screening.

6. Participant has a urine albumin-to-creatinine ratio (UACR) < 300 mg/g at screening in
a single urine specimen (per National Kidney Foundation guideline).

7. 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.

8. 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. Participant is actively pursuing weight loss and/or lifestyle changes.

3. Participant has a history of pressure ulcers.

4. Participant has a stated history of Deep Vein Thrombosis (DVT), recent (within last 3
months) pulmonary embolism, or has a positive D-dimer test and lower extremity
ultrasound at screening, or a known hypercoagulable condition, or other clotting or
bleeding disorders.

5. Participant has poorly controlled hypertension or hypotension in the opinion of the
study PI.

6. Participant has untreated hypothyroidism or hyperthyroidism.

7. 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.

8. Participant is currently taking prescription strength anti-inflammatory medication, or
has taken prescription strength anti-inflammatory medication in the 6 weeks prior to
screening.

9. Participant has had surgery requiring > 2 days of hospitalization in the last 3 weeks
prior to screening visit.

10. Participant has an active malignancy or autoimmune disease.

11. 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.

12. Participant has a chronic, contagious, infectious disease, such as active
tuberculosis, Hepatitis B or C, or HIV.

13. Participant is an amputee and/or has presence of partial or full artificial limb.

14. 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 EKG
at screening. In the event of a positive stress test, participants are referred to
their primary care physician. If the electrocardiogram (ECGEKG) is determined to be a
false negative, participant may be allowed to participate in study.

15. Participant has a history of, or currently has uncontrolled severe diarrhea, nausea or
vomiting.

16. 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.

17. 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 of beer (12 oz) /day.

18. 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) in the opinion
of the PI or medical provider, starting two weeks prior to enrollment 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.

19. Participant has a mini-Mental State Examination score < 21.

20. 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

21. Unable to participate in magnetic resonance (MR) or Dual-energy X-ray absorptiometry
(DEXA) assessments due to physical limitations of equipment tolerances (e.g., MRI bore
size and DEXA 450-pound weight limit) based on Investigator's judgment at screening
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