Clinical trial: PGC-1 & MUSCLE MITOCHONDRIAL DYSFUNCTION IN DIABETES: AIMS 1-4 (NCT03323788)

Eligibility criteria:
Aims 1-3.

          1. Age 30-59

          2. BMI: Lean, BMI less than or equal to 25; Obese, BMI between 30- 50; type 2 diabetic,
             BMI between 30- 50.

          3. Subjects must be able to communicate meaningfully with the investigator and must be
             legally competent to provide written informed consent.

          4. 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.

          5. Subjects must range in age as described in each specific protocol.

          6. Subjects must have the following laboratory values:

               1. Hematocrit ≥ 35 vol%

               2. Serum creatinine ≤ 1.6 mg/dl

               3. AST (SGOT) < 2 times upper limit of normal

               4. ALT (SGPT) < 2 times upper limit of normal

               5. Alkaline phosphatase < 2 times upper limit of normal

               6. Triglycerides < 150 mg/dl for nondiabetics (except for Aim 4).

               7. Triglycerides <300 for diabetics (except for Aim 4)

               8. INR ≤ 1.3 Aim 4

        1. Age 30-59 2. BMI: Lean, BMI less than or equal to 25; Obese, BMI between 30- 50. 3.
        Patients may have normal or impaired glucose tolerance. 4. Subjects must be able to
        communicate meaningfully with the investigator and must be legally competent to provide
        written informed consent.

        5. 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.

        6. Subjects must have the following laboratory values:

          1. Hematocrit ≥ 35 vol%

          2. Serum creatinine ≤ 1.6 mg/dl

          3. AST (SGOT) < 2 times upper limit of normal

          4. ALT (SGPT) < 2 times upper limit of normal

          5. Alkaline phosphatase < 2 times upper limit of normal

          6. Triglycerides > 300 mg/dl for nondiabetics, > 250 mg/dl for impaired glucose
             tolerance.

          7. INR ≤ 1.3 7. Patients must be prescribed gemfibrozil from their doctor

        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. Patients with type 2 diabetes will be excluded if they
             are taking thiazolidinediones, but may be taking sulfonylureas or other medications
             known to work through effects on insulin sectretion.

             2. Subjects receiving Gemfibrozil must not also be receiving a statin. 3. 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.

             4. 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.
No condition on gender to be admitted to the trial.

Subject must be at least 30 Years old.
Subject must be at most 59 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment