Determining Cell- and Spatially-distinct Skeletal Muscle Transcriptional Aberrations in Insulin Resistance

Part of paid clinical trials in Orlando, Florida.

Sponsor
AdventHealth Translational Research Institute
Study ID
NCT07516509
Status
Not Yet Recruiting

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Conditions

  • Insulin Resistance

Eligibility Criteria

Sex
ALL
Age
30 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • VO2 Max — OTHER
    Aerobic Fitness determined by measuring maximal volume of oxygen consumed (VO2max) during a stationary bicycle exercise test.
  • DEXA — OTHER
    DEXA scans will be performed to measure body fay and estimate muscle mass.
  • Peripheral Microvascular Reactivity — OTHER
    Post-occlusive reactive hyperemia (POHR) will be measured using Near Infrared Spectroscopy
  • Skeletal Muscle Insulin Sensitivity — OTHER
    Skeletal Muscle Insulin Sensitivity will be assessed with a hyperinsulinemic -euglycemic clamp with stable glucose isotope tracers.
  • Non-Oxidative Glucose Disposal — OTHER
    Rates of glucose oxidation will be measured with indirect calorimetry during the hyperinsulinemic -euglycemic clamp. Rates of non-oxidized glucose disposal will be calculated by subtracting rates of glucose oxidation from rates of glucose disposal during the hyperinsulinemic -euglycemic clamp.
  • Muscle tissue Biopsy — OTHER
    A biopsy of the Vastus Lateralis muscle will be performed using the Bergstrom technique. A biopsy will be obtained before the clamp and immediately after the clamp.

Study Details

The purpose of this study is to find new signs or signals in muscle cells that can help us understand when the body isn't responding well to insulin (a condition called insulin resistance).

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
36 participants (estimated)

Arms

  • Arm: Group A - Lean individuals with insulin sensitivity (IS-Lean)
  • Arm: Group B - Individuals with obesity and insulin sensitivity (IS-Obesity)
  • Arm: Group C - Individuals with obesity and insulin resistance (IR-Obesity)

Primary Outcome Measure

Skeletal muscle insulin sensitivity [ Time Frame: 6.5 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AdventHealth Translational Research InstituteOrlandoFlorida32804-

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AdventHealth Translational Research Institute· Orlando, FL

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