Plasma Triglyceride Extraction by The Muscle

Obesity Clinical Trial

Official title:

Regulation of the Plasma Triglyceride Extraction in Muscle in Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860911
• Other study ID #: 12-005173
• Status: Completed
• Phase: Phase 1
• Start date: April 2013
• Est. completion date: August 31, 2016

Study information

• Verified date: October 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Drug:
• Insulin

• NG-monomethyl-L-arginine

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride extraction across the forearm		Measured during a 7-hour infusion study
Secondary	Muscle microvascular blood volume		Selected 15-minute periods during the 7 hour infusion study

External Links

•   Mayo Clinic Clinical Trials