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Observational Study on Insulin Resistance and Muscle Cells

This study aims to understand why some people's bodies don't respond well to insulin, a condition called insulin resistance. Researchers will look closely at muscle cells to find specific changes that might explain this. They will measure your aerobic fitness (VO2 Max), body fat and muscle mass (DEXA), how blood vessels react (Peripheral Microvascular Reactivity), and how your muscles use insulin (Skeletal Muscle Insulin Sensitivity). They will also measure how your body uses sugar (Non-Oxidative Glucose Disposal). This study is for men and women aged 30 to 65 who are sedentary and have a stable weight, with different body mass indexes (BMI). The goal is to identify new signals in muscle cells that can help us better understand insulin resistance.

Study design
This is an observational study with a planned enrollment of 36 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo tests including VO2 Max, DEXA scans, Peripheral Microvascular Reactivity measurements, and Skeletal Muscle Insulin Sensitivity assessments. These measurements will occur at various time points, with some as short as 30 minutes and others up to 9 months.
Compensation
Not stated in the trial record.
Follow-up
Skeletal muscle insulin sensitivity will be measured at 6.5 hours, skeletal muscle cell composition at 30 minutes, and cell and region specific transcriptomic profiles at 9 months.

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NCT07516509

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

Recruiting
Not specifiedAges 30–65Observational
AdventHealth Translational Research Institute
~36 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:VO2 MaxDEXAPeripheral Microvascular ReactivitySkeletal Muscle Insulin SensitivityNon-Oxidative Glucose DisposalMuscle tissue Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Skeletal muscle insulin sensitivity
Measured over 6.5 hours
+2 more outcomes measured

Conditions

Insulin Resistance

Explore related trials

Insulin Resistance

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Katie Whytock, PhD · PRINCIPAL_INVESTIGATOR · Study Principal Investigator

Who to contact

Recruitment Department
[email protected]
407-303-7100
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

All Groups

Exclusion

Positive ECG (\> 2mm ST segment depression) without PCP cardiologist permission to participate
Signs or symptoms of cardiovascular decomposition (eg. hypotensive response to exercise)
Onset of angina or angina like symptoms, shortness of breath, change in heart rhythm, signs of poor perfusion (light-headedness), tightness. 31. The following medication use is exclusionary;
Dose change for any chronic-use drug in the last 3 months;
Any medications that can alter glucose homeostasis (eg. steroids, glucocorticoids, nicotinic acid). Acute therapy (5-7 days) is not exclusionary however; participant must be agreeable to a washout period of 5-7 days prior to day of biopsy.
Blood thinners such as Coumadin, Lovenox etc. Aspirin is not exclusionary however; participant must be agreeable to a washout period of \> 10 days prior to day of biopsy
All Weight loss medications including but not limited toGLP-1 agonists- Wegovy, liraglutide, semaglutide, Trulicity (dulaglutide), Phentermine and Contrave
Cardiovascular: beta blockers and centrally acting anti-hypertensive drugs, anticoagulants, antiarrhythmics, and antiplatelet drugs (other than aspirin ≤100 mg/day);
Psychiatric: chronic use of medium- or long-acting sedatives and hypnotics, including all benzodiazepines (short-acting non-benzodiazepine sedative-hypnotics are allowed), mood stabilizers, antiepileptic drugs, stimulants, Attention-Deficit/Hyperactivity Disorder (ADHD) drugs, anti-psychotic drugs, anti-depressant medication (e.g. Bupropion, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine re-uptake inhibitors (SNRIs)).
Pulmonary/Inflammation: chronic oral steroids (occasional use of inhaled steroids are allowed), burst/taper oral steroids more than once in the last 12 months, B2-agonists (allowed if on stable dose at least 3 months).
Genitourinary: 5-alpha reductase inhibitors, daily use of phosphodiesterase type 5 inhibitor.
Hormonal: androgenic anabolic steroids, anti-estrogens, anti-androgens, estrogens and/or progestins used for reasons other than birth control, growth hormone, insulin like growth factor-I, growth hormone releasing hormone,
any drugs used to treat diabetes mellitus or lower blood glucose including metformin, thiazolidinediones, SGLT-2 inhibits or insulin
any drugs used specifically to induce muscle growth/hypertrophy or augment exercise-induced muscle hypertrophy
Pain/Inflammation: narcotics and narcotic receptor agonists, regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen, muscle relaxants ≥2 days per week
Other: chronic systemic antimicrobials (antibiotic, antiviral, antifungal, antiparasite, etc.) for any reason, high-potency topical steroids if ≥10% surface area using rule of 9s, continuous/chronic use of antibiotics or other anti-infectives for treatment or prevention, monoclonal antibodies, anti-rejection medications/immune suppressants. Participants can be re-screened after a 3 month washout period if antimicrobial use is only used acutely \< 2 weeks. 32. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.

What this trial measures

  • Skeletal muscle insulin sensitivity6.5 hours

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

  • Skeletal muscle cell composition30 minutes

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

  • Cell and Region Specific Transcriptomic profiles9 months

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