Molecular Regulation of Muscle Glucose Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mayo Clinic
Sponsor:
Collaborator:
Arizona State University
Information provided by (Responsible Party):
Lori R. Roust, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01581736
First received: February 15, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Obesity
Type 2 Diabetes Mellitus
Drug: U100 Humulin
Other: Exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Molecular Regulation of Muscle Glucose Metabolism

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • insulin sensitivity [ Time Frame: one month from date of volunteer study ] [ Designated as safety issue: No ]
    euglycemic clamp


Secondary Outcome Measures:
  • acetylation of mitochondrial adenine nucleotide translocase [ Time Frame: within 6 months of volunteer study ] [ Designated as safety issue: No ]
    proteomics analysis of post translational modification of proteins obtained from isolated mitochondria


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise
Proteomics of muscle after a single bout of exercise compared to baseline with insulin infusion at rate of 80mU/m2 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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581736

Contacts
Contact: Roxane McLaughlin, RN 480-301-4142 mclaughlin.roxane@mayo.edu

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Roxane McLaughlin, RN    480-301-4142    mclaughlin.roxane@mayo.edu   
Contact: Seth Ratihn, PA    480-301-4142    ratihn.seth@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Arizona State University
Investigators
Principal Investigator: Lori Roust, MD Mayo Clinic
Principal Investigator: Lawrence J. Mandarino, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Lori R. Roust, Consultant in Endocrinology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01581736     History of Changes
Other Study ID Numbers: 11-004005
Study First Received: February 15, 2012
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
insulin resistance
mitochondria

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014