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OpenTrials
Completed

NCT Number: NCT01860911

Plasma Triglyceride Extraction by The Muscle

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Insulin

Drug

NG-Monomethyl-L-Arginine

Drug

Primary outcomes

  1. Triglyceride extraction across the forearm

    Time frame: Measured during a 7-hour infusion study

Secondary outcomes

  1. Muscle microvascular blood volume

    Time frame: Selected 15-minute periods during the 7 hour infusion study

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Regulation of the Plasma Triglyceride Extraction in Muscle in Insulin Resistance

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 23, 2013
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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