Plasma Triglyceride Extraction by The Muscle

Regulation of the Plasma Triglyceride Extraction in Muscle in Insulin Resistance

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Insulin Resistance
• Intervention / Treatment: Drug: Insulin; Drug: NG-monomethyl-L-arginine

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Triglyceride extraction across the forearm	Measured during a 7-hour infusion study

Secondary Outcome Measures

Outcome Measure	Time Frame
Muscle microvascular blood volume	Selected 15-minute periods during the 7 hour infusion study

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Lori Roust, MD, Mayo Clinic; Principal Investigator: Christos S Katsanos, PhD, Arizona State University/Mayo Clinic Arizona

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; omega-N-Methylarginine
• Other Study ID Numbers: 12-005173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No