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Plasma Triglyceride Extraction by The Muscle

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ClinicalTrials.gov Identifier: NCT01860911
Recruitment Status : Active, not recruiting
First Posted : May 23, 2013
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Lori R. Roust, Mayo Clinic

Brief Summary:
Increased accumulation of fat into the muscles is associated with what is called insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are insulin-resistant. The investigators are specifically interested in how a hormone called insulin is involved in this process. Findings from this research will contribute to our understanding of why insulin-resistant people have increased accumulation of fat in their muscles, and ultimately help to design appropriate interventions to prevent type 2 Diabetes.

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Drug: Insulin Drug: NG-monomethyl-L-arginine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Regulation of the Plasma Triglyceride Extraction in Muscle in Insulin Resistance
Study Start Date : April 2013
Estimated Primary Completion Date : September 19, 2019
Estimated Study Completion Date : September 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin-Sensitive
One group consists of insulin sensitive volunteers.
Drug: Insulin
Drug: NG-monomethyl-L-arginine
Experimental: Insulin-Resistant
One group consists of insulin resistant volunteers.
Drug: Insulin



Primary Outcome Measures :
  1. Triglyceride extraction across the forearm [ Time Frame: Measured during a 7-hour infusion study ]

Secondary Outcome Measures :
  1. Muscle microvascular blood volume [ Time Frame: Selected 15-minute periods during the 7 hour infusion study ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI): < 25 kg/m2 or > 30 kg/m2;
  • Insulin sensitivity index (ISI): insulin-sensitive ISI ≥ 7, insulin-resistant ISI ≤ 5.

Exclusion Criteria:

  • Medication or supplements known to affect either endothelial function or lipid metabolism (i.e. arginine, protein, fish oil)
  • Acute illness
  • Uncontrolled metabolic disease, including liver or renal disease
  • Atrial fibrillation, history of syncope, limiting or unstable angina, congestive heart failure, known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts
  • Cardiac pacemaker or other medical device implanted in the body
  • Pulmonary hypertension or other unstable cardiopulmonary conditions
  • ECG documented abnormalities or valvular disease
  • Low hemoglobin or hematocrit (i.e., lower than accepted laboratory values)
  • History of hypertension or elevated blood pressure (systolic, >140 mmHg or a diastolic, >95 mmHg)
  • History of hyperlipidemia or plasma triglyceride concentration >200 mg/dl
  • Diagnosed diabetes, or 2-h plasma glucose >200 mg/dl during an oral glucose tolerance test
  • Current participation in a weight-loss regimen, including extreme dietary practices
  • Use of anabolic steroids or corticosteroids (within 3 months)

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 ClinicalTrials.gov identifier (NCT number): NCT01860911


Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
American Diabetes Association
Investigators
Principal Investigator: Lori Roust, MD Mayo Clinic
Principal Investigator: Christos S Katsanos, PhD Arizona State University/Mayo Clinic Arizona

Responsible Party: Lori R. Roust, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01860911     History of Changes
Other Study ID Numbers: 12-005173
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
omega-N-Methylarginine
Hypoglycemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action