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Molecular Regulation of Muscle Glucose Metabolism

This study has been terminated.
(PI job change)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581736
First Posted: April 20, 2012
Last Update Posted: November 27, 2017
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.
Collaborator:
Arizona State University
Information provided by (Responsible Party):
Lori R. Roust, Mayo Clinic
February 15, 2012
April 20, 2012
November 27, 2017
April 2012
April 2016   (Final data collection date for primary outcome measure)
insulin sensitivity [ Time Frame: one month from date of volunteer study ]
euglycemic clamp
Same as current
Complete list of historical versions of study NCT01581736 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Molecular Regulation of Muscle Glucose Metabolism
Molecular Regulation of Muscle Glucose Metabolism
This protocol is being conducted to determine the mechanisms responsible for insulin resistance, obesity and type 2 diabetes.
This protocol involves performance of a hyperinsulinemic euglycemic clamp with 2 muscle biopsies and an exercise study with a muscle biopsy.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Obesity
  • Type 2 Diabetes Mellitus
  • 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.
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.
Interventions:
  • Drug: U100 Humulin
  • Other: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
April 2016
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01581736
11-004005
No
Not Provided
Not Provided
Lori R. Roust, Mayo Clinic
Mayo Clinic
Arizona State University
Principal Investigator: Lori Roust, MD Mayo Clinic
Principal Investigator: Lawrence J. Mandarino, PhD Mayo Clinic
Mayo Clinic
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP