ClinicalTrials.gg
RecruitingNCT07516509POINTS 2Updated Aug 12, 2026

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

An observational study in Insulin Resistance, sponsored by AdventHealth Translational Research Institute. Recruiting at 1 site in United States. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by AdventHealth Translational Research Institute · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
36
Ages
30 Years to 65 Years
Sex
All
01

Study 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).

Read the 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

02

Conditions studied

  • Insulin Resistance

Browse trials for

03

In context

Insulin Resistance

2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.

This study's planned enrollment of 36 is below the median of 82 across 478 observational studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

AdventHealth Translational Research Institute is the lead sponsor of 57 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All Groups

    1. 30 to 65 years of age
    2. Stable weight (No Gain/Loss of >10 lbs in 6 months)
    3. Sedentary (≤ 1 continuous exercise/week)
    4. Non-smoker
    5. Resting Blood Pressure ≤ 150mmHg systolic and ≤ 95 mmHg diastolic

Group A - Lean individuals with insulin sensitivity (IS-Lean)

  1. 18-25 kg/m2
  2. ≤ 5.6% at screening
  3. Blood glucose level ≤ 140 mg/dL 2hr after a 75g oral glucose tolerance test

Group B - Individuals with obesity and insulin sensitivity (IS-Obesity)

  1. BMI 30-40 kg/m2
  2. Hemoglobin A1c ≤ 5.6% at screening
  3. Blood glucose level ≤ 140 mg/dL 2hr after a 75g oral glucose tolerance test

Group C - Individuals with obesity and insulin resistance (IR-Obesity)

  1. BMI 30-40 kg/m2
  2. Hemoglobin A1c ≤ 6.4 % at screening
  3. Blood glucose level 140-199 mg/dL 2hr after a 75g oral glucose tolerance test

Exclusion criteria

Exclusion Criteria:

  1. CVD including h/o MI, within the past year
  2. Peripheral Vascular Disease
  3. Diagnosed with Type I or Type II diabetes
  4. Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
  5. Previous history of pulmonary emboli
  6. Peripheral Neuropathy
  7. Anemia (Hematocrit \<34%, \< 14 gm/dL for men and \<12.3 gm/dL for women) at screening
  8. Currently pregnant (pregnancy test performed on day of DEXA scan in women of ); post-partum during the last 12 months; lactating during the last 12 months; planning to become pregnant during the participation period
  9. Polycystic Ovarian Syndrome (PCOS) (self-report)
  10. Hospitalization for COVID-19 infection in the past 12 months; individuals who tested positive for COVID-19 but were not hospitalized must be symptom-free at least 14 days
  11. Partial and/or full hysterectomy (self-report)
  12. Not willing to archive biospecimens for future use
  13. Any to exercise testing according to ACSM guidelines
  14. Inability and/ or unwillingness to comply with the protocol as written
  15. Active alcohol or substance abuse (Past 5 Years)
  16. Positive toxicology result from screening visit or chronic use of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Methadone, Opiate, THC, Cannabis, Tricyclics, or Oxycodone.
  17. Dyslipidemia (fasting triglycerides >500 mg/dL; low-density lipoprotein cholesterol (LDL-C) >190 mg/dL; total cholesterol >300 mg/dL);
  18. >80, AST>80, Alk Phos >240 if a participant presents with liver functions out of these ranges at screening the MI or PI can give discretion to participate
  19. Proteinuria (defined as > 1+) at screening
  20. Kidney disease (creatinine >1.6 mg/dl or estimated \<60 mL/min/1.73m2);
  21. Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; (HIV); active or C undergoing antiviral therapy.
  22. Receiving active treatment (including monoclonal antibodies) for disorders within the last 6 months;
  23. Hypothyroidism (sTSH>8) at screening or on thyroid replacement therapy
  24. Abnormal bleeding or coagulopathy (self-report) or history of a bleeding disorder or clotting abnormality
  25. History of cancer (other than non-melanoma skin cancer) within the last 5 years (not in remission); anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months;
  26. Previous bariatric or other surgery for obesity
  27. Females currently on hormone replacement therapy (HRT) less than 6 months
  28. Females with an irregular menstrual cycle
  29. Previous difficulty with lidocaine or other local anesthetic
  30. ACS symptoms:

    • Positive (> 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. , glucocorticoids, nicotinic acid). Acute therapy (5-7 days) is not exclusionary however; participant must be agreeable to a of 5-7 days prior to day of .
    • 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 , 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.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
36 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group A - Lean individuals with insulin sensitivity (IS-Lean)

    Other: VO2 Max · Other: DEXA · Other: Peripheral Microvascular Reactivity · Other: Skeletal Muscle Insulin Sensitivity · Other: Non-Oxidative Glucose Disposal · Other: Muscle tissue Biopsy

  • Group B - Individuals with obesity and insulin sensitivity (IS-Obesity)

    Other: VO2 Max · Other: DEXA · Other: Peripheral Microvascular Reactivity · Other: Skeletal Muscle Insulin Sensitivity · Other: Non-Oxidative Glucose Disposal · Other: Muscle tissue Biopsy

  • Group C - Individuals with obesity and insulin resistance (IR-Obesity)

    Other: VO2 Max · Other: DEXA · Other: Peripheral Microvascular Reactivity · Other: Skeletal Muscle Insulin Sensitivity · Other: Non-Oxidative Glucose Disposal · Other: Muscle tissue Biopsy

Interventions

  • OtherVO2 Max

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

  • OtherDEXA

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

  • OtherPeripheral Microvascular Reactivity

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

  • OtherSkeletal Muscle Insulin Sensitivity

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

  • OtherNon-Oxidative Glucose Disposal

    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.

  • OtherMuscle tissue Biopsy

    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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07516509
Lead sponsor
AdventHealth Translational Research Institute
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
Jun 11, 2026
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 12, 2026

Study contacts

Recruitment Department
Contact
CFD.TRI.Recruitment@AdventHealth.com
407-303-7100
Katie Whytock, PhD
principal investigator · Study Principal Investigator

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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