Plasma Triglyceride Extraction by The Muscle

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01860911

Collaborator

American Diabetes Association (Other)

Enrollment

Location

Arms

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 Disease	Intervention/Treatment	Phase
Obesity Insulin Resistance	Drug: Insulin Drug: NG-monomethyl-L-arginine	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

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

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:

Additional relevant MeSH terms:

Insulin Resistance

omega-N-Methylarginine

Study Results

No Results Posted as of Oct 8, 2021