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

ConditionInsulin Resistance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-65
SponsorAdventHealth Translational Research Institute

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

All Groups

30 to 65 years of age

Stable weight (No Gain/Loss of >10 lbs in 6 months)

Sedentary (≤ 1 continuous exercise/week)

Disqualifiers

Clinically significant CVD including h/o MI, within the past year

Peripheral Vascular Disease

Diagnosed with Type I or Type II diabetes

Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease

Trial population

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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • VO2 Max

    Other intervention

    Aerobic Fitness determined by measuring maximal volume of oxygen consumed (VO2max) during a stationary bicycle exercise test.

  • DEXA

    Other intervention

    DEXA scans will be performed to measure body fay and estimate muscle mass.

  • Peripheral Microvascular Reactivity

    Other intervention

    Post-occlusive reactive hyperemia (POHR) will be measured using Near Infrared Spectroscopy

  • Skeletal Muscle Insulin Sensitivity

    Other intervention

    Skeletal Muscle Insulin Sensitivity will be assessed with a hyperinsulinemic -euglycemic clamp with stable glucose isotope tracers.

  • Non-Oxidative Glucose Disposal

    Other intervention

    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 intervention

    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.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Group A - Lean individuals with insulin sensitivity (IS-Lean)6 interventions
Group B: Group B - Individuals with obesity and insulin sensitivity (IS-Obesity)6 interventions
Group C: Group C - Individuals with obesity and insulin resistance (IR-Obesity)6 interventions

Trial outcomes

Primary outcomes

1

Skeletal muscle insulin sensitivity

Skeletal muscle insulin sensitivity will be quantified with the HE clamp and compared between groups.

Time frame
6.5 hours
2

Skeletal muscle cell composition

Cell composition will be assessed with single cell RNA-seq and spatial transcriptomics and compared between the groups

Time frame
30 minutes
3

Cell and Region Specific Transcriptomic profiles

Cell and region specific, basal and insulin-induced transcriptomic profiles will be assessed using scRNA-seq and spatial transcriptomics and compared between the groups

Time frame
9 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AdventHealth Translational Research Institute

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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