NCT01860911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

3.4 years

First QC Date

May 21, 2013

Last Update Submit

October 1, 2021

Conditions

ObesityInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Triglyceride extraction across the forearm

    Measured during a 7-hour infusion study

Secondary Outcomes (1)

  • Muscle microvascular blood volume

    Selected 15-minute periods during the 7 hour infusion study

Study Arms (2)

Insulin-Sensitive

EXPERIMENTAL

One group consists of insulin sensitive volunteers.

Drug: InsulinDrug: NG-monomethyl-L-arginine

Insulin-Resistant

EXPERIMENTAL

One group consists of insulin resistant volunteers.

Drug: Insulin

Interventions

InsulinDRUG
Insulin-ResistantInsulin-Sensitive
NG-monomethyl-L-arginineDRUG
Insulin-Sensitive

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI): \< 25 kg/m2 or \> 30 kg/m2;
  • Insulin sensitivity index (ISI): insulin-sensitive ISI ≥ 7, insulin-resistant ISI ≤ 5.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

Insulinomega-N-Methylarginine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsArginineAmino Acids, BasicAmino AcidsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Lori Roust, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Christos S Katsanos, PhD

    Arizona State University/Mayo Clinic Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 23, 2013

Study Start

April 1, 2013

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

October 8, 2021

Record last verified: 2021-10

Locations

US(1)