Molecular Regulation of Muscle Glucose Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01581736
Recruitment Status : Terminated (PI job change)
First Posted : April 20, 2012
Last Update Posted : November 27, 2017
Arizona State University
Information provided by (Responsible Party):
Lori R. Roust, Mayo Clinic

Brief Summary:
This protocol is being conducted to determine the mechanisms responsible for insulin resistance, obesity and type 2 diabetes.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Mellitus Drug: U100 Humulin Other: Exercise Phase 1

Detailed Description:
This protocol involves performance of a hyperinsulinemic euglycemic clamp with 2 muscle biopsies and an exercise study with a muscle biopsy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Molecular Regulation of Muscle Glucose Metabolism
Study Start Date : April 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exercise
Proteomics of muscle after a single bout of exercise compared to baseline with U100 Humulin infusion at rate of 80 milliunits(mU)/m^2 surface area.
Drug: U100 Humulin
Infused at a rate of 80/mU/m2 surface area per minute one time over 2 hours
Other Names:
  • Humulin
  • Human insulin

Other: Exercise
Single episode of exercise riding a stationary bike.

Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: one month from date of volunteer study ]
    euglycemic clamp

Secondary Outcome Measures :
  1. acetylation of mitochondrial adenine nucleotide translocase [ Time Frame: within 6 months of volunteer study ]
    proteomics analysis of post translational modification of proteins obtained from isolated mitochondria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

    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 (During Liposyn/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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01581736

United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Arizona State University
Principal Investigator: Lori Roust, MD Mayo Clinic
Principal Investigator: Lawrence J. Mandarino, PhD Mayo Clinic

Responsible Party: Lori R. Roust, Consultant in Endocrinology, Mayo Clinic Identifier: NCT01581736     History of Changes
Other Study ID Numbers: 11-004005
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by Lori R. Roust, Mayo Clinic:
insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs