Diabetes Clinical Trial
— PGC-1Official title:
PGC-1 and Mitochondrial Dysfunction in Diabetes, Aims 4 & 5
Verified date | May 2014 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether insulin resistance is accompanied by "exercise resistance". Investigators will use mass spectrometry and proteomics analysis to test the hypothesis is that a bout of exercise that increases mitochondrial protein abundance in lean, healthy individuals is less effective in insulin resistant patients.
Status | Completed |
Enrollment | 16 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 55 Years |
Eligibility |
Inclusion Criteria 1. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. 2. Subjects may be of either sex with age as described in each protocol. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period. 3. Subjects must range in age as described in each specific protocol. 4. Subjects must have the following laboratory values: 1. Hematocrit = 35 vol% 2. Serum creatinine = 1.6 mg/dl 3. Aspartate Aminotransferase (AST) (SGOT) < 2 times upper limit of normal 4. Alanine Aminotransferase (ALT) (SGPT) < 2 times upper limit of normal 5. Alkaline phosphatase < 2 times upper limit of normal 6. Triglycerides < 150 mg/dl. 7. Prothrombin Time (PT) 11.7 -14.3 seconds (during Intralipid/heparin infusion,PT will be determined to insure that it is < 1.5-2.0 times the normal value.) 8. Partial thromboplastin time (PTT) 23.0-37.0 seconds. Exclusion Criteria 1. Subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for the past three months before entry into the study. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. Subjects taking systemic glucocorticoids are excluded. 2. Subjects with a history of clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied. 3. Recent systemic or pulmonary embolus, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, systolic BP>180, diastolic BP>105, autonomic neuropathy, resting heart rate >100, electrolyte abnormalities. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Protein Concentration of Mitochondria | Protein concentration will be determined from muscle biopsies by the method of Lowry. 75 micrograms of muscle lysate proteins will be separated on a 10% Sodium Dodecyl Sulfate Polyacrylamide Gel, and then visualized with Coomassie stain. The gel lane will be cut into cubes, digested with trypsin and cleaned, then protein abundance will be determined using spectral counting. | Study Day 4 (30 min after exercise) and (24 hours after exercise) | No |
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