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Not Yet RecruitingNCT07516509

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

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
36 (estimated)
Sponsor
AdventHealth Translational Research Institute · Academic / Other
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Accepted

Summary

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).

Detailed description

The primary goal of this research is to look at gene expression changes to insulin stimulation in different cells and areas of skeletal muscle and how they are affected by obesity and insulin resistance. The investigators are studying sedentary men and women between the ages of 30 and 65 years with; either a body mass index (BMI) between 18-25 kg/m2 or 30-40 kg/m2

Conditions

Interventions

TypeNameDescription
OTHERVO2 MaxAerobic Fitness determined by measuring maximal volume of oxygen consumed (VO2max) during a stationary bicycle exercise test.
OTHERDEXADEXA scans will be performed to measure body fay and estimate muscle mass.
OTHERPeripheral Microvascular ReactivityPost-occlusive reactive hyperemia (POHR) will be measured using Near Infrared Spectroscopy
OTHERSkeletal Muscle Insulin SensitivitySkeletal Muscle Insulin Sensitivity will be assessed with a hyperinsulinemic -euglycemic clamp with stable glucose isotope tracers.
OTHERNon-Oxidative Glucose DisposalRates 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.
OTHERMuscle tissue BiopsyA 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.

Timeline

Start date
2026-06-01
Primary completion
2028-12-01
Completion
2028-12-01
First posted
2026-04-08
Last updated
2026-04-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07516509. Inclusion in this directory is not an endorsement.