Back to resultsPlasma Triglyceride Extraction by The Muscle
Primary Purpose
Obesity, Insulin Resistance
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin
NG-monomethyl-L-arginine
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
Eligibility Criteria
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)
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Insulin-Sensitive
Insulin-Resistant
Arm Description
One group consists of insulin sensitive volunteers.
One group consists of insulin resistant volunteers.
Outcomes
Primary Outcome Measures
Triglyceride extraction across the forearm
Secondary Outcome Measures
Muscle microvascular blood volume
Full Information
NCT ID
NCT01860911
First Posted
May 21, 2013
Last Updated
October 1, 2021
Sponsor
Mayo Clinic
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT01860911
Brief Title
Plasma Triglyceride Extraction by The Muscle
Official Title
Regulation of the Plasma Triglyceride Extraction in Muscle in Insulin Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
American Diabetes Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin-Sensitive
Arm Type
Experimental
Arm Description
One group consists of insulin sensitive volunteers.
Arm Title
Insulin-Resistant
Arm Type
Experimental
Arm Description
One group consists of insulin resistant volunteers.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Type
Drug
Intervention Name(s)
NG-monomethyl-L-arginine
Primary Outcome Measure Information:
Title
Triglyceride extraction across the forearm
Time Frame
Measured during a 7-hour infusion study
Secondary Outcome Measure Information:
Title
Muscle microvascular blood volume
Time Frame
Selected 15-minute periods during the 7 hour infusion study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Roust, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christos S Katsanos, PhD
Organizational Affiliation
Arizona State University/Mayo Clinic Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Plasma Triglyceride Extraction by The Muscle
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