Plasma Triglyceride Extraction by The Muscle

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01860911
Collaborator
American Diabetes Association (Other)
33
Enrollment
1
Location
2
Arms
41
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
33 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
Actual Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Aug 31, 2016
Actual Study Completion Date :
Aug 31, 2016

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Triglyceride extraction across the forearm [Measured during a 7-hour infusion study]

Secondary Outcome Measures

  1. Muscle microvascular blood volume [Selected 15-minute periods during the 7 hour infusion study]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Mayo Clinic in ArizonaScottsdaleArizonaUnited States85259

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Lori R. Roust, PI, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01860911
Other Study ID Numbers:
  • 12-005173
First Posted:
May 23, 2013
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021