Molecular Regulation of Muscle Glucose Metabolism
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| City: |
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Scottsdale |
| State: |
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Arizona |
| Zip Code: |
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85259 |
| Conditions: |
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Obesity - Type 2 Diabetes Mellitus |
| Purpose: |
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This protocol is being conducted to determine the mechanisms responsible for insulin
resistance, obesity and type 2 diabetes.
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| Study Summary: |
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This protocol involves performance of a hyperinsulinemic euglycemic clamp with 2 muscle
biopsies and an exercise study with a muscle biopsy.
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| Criteria: |
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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, age as described in each protocol. Female subjects
must be non-lactating and must either be at least two years post-menopausal, (if
diabetic or obese) or be using adequate contraceptive precautions (i.e. oral
contraceptives, approved hormonal implant, intrauterine device, diaphragm with
spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral
tubal ligation, bilateral oophorectomy). Female patients (except for those patients
who have undergone a hysterectomy or bilateral oophorectomy) are 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. All nondiabetic subjects must have normal oral glucose tolerance.
5. Subjects must have the following laboratory values:
Hematocrit ≥ 35 vol% Serum creatinine ≤ 1.6 mg/dl AST (SGOT)
< 2 times upper limit of normal ALT (SGPT) < 2 times
upper limit of normal Alkaline phosphatase < 2 times upper limit of normal
Triglycerides < 150 mg/dl. PT 11.7 -14.3 (During Liposyn/heparin infusion, PT will be
determined to insure that it is < 1.5-2.0 times the normal value.) PTT 23.0-37.0.
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 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.
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| NCT ID: |
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NCT01581736 |
| Primary Contact: |
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Principal Investigator
Lori Roust, MD
Mayo Clinic
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| Backup Contact: |
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N/A |
| Location Contact: |
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Scottsdale, Arizona 85259
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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