Insulin ResistancePOINTS 2NCT07516509
Determining Cell- and Spatially-distinct Skeletal Muscle Transcriptional Aberrations in Insulin Resistance
An observational study of Insulin Resistance, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- VO2 Max, DEXA and Peripheral Microvascular Reactivity
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All Groups
- 30 to 65 years of age
- Stable weight (No Gain/Loss of >10 lbs in 6 months)
- Sedentary (≤ 1 continuous exercise/week)
- Non-smoker
- Resting Blood Pressure ≤ 150mmHg systolic and ≤ 95 mmHg diastolic
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- Group A - Lean individuals with insulin sensitivity (IS-Lean)
- BMI 18-25 kg/m2
- Hemoglobin A1c ≤ 5.6% at screening
- Blood glucose level ≤ 140 mg/dL 2hr after a 75g oral glucose tolerance test
- Group B - Individuals with obesity and insulin sensitivity (IS-Obesity)
- BMI 30-40 kg/m2
- Hemoglobin A1c ≤ 5.6% at screening
- Blood glucose level ≤ 140 mg/dL 2hr after a 75g oral glucose tolerance test
- Group C - Individuals with obesity and insulin resistance (IR-Obesity)
- BMI 30-40 kg/m2
- Hemoglobin A1c ≤ 6.4 % at screening
- Blood glucose level 140-199 mg/dL 2hr after a 75g oral glucose tolerance test
Who cannot join
- 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
- Previous history of pulmonary emboli
- Peripheral Neuropathy
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- Anemia (Hematocrit <34%, Hemoglobin < 14 gm/dL for men and <12.3 gm/dL for women) at screening
- Currently pregnant (pregnancy test performed on day of DEXA scan in women of child-bearing potential); post-partum during the last 12 months; lactating during the last 12 months; planning to become pregnant during the participation period
- Polycystic Ovarian Syndrome (PCOS) (self-report)
- 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
- Partial and/or full hysterectomy (self-report)
- Not willing to archive biospecimens for future use
- Any contraindications to exercise testing according to ACSM guidelines
- Inability and/ or unwillingness to comply with the protocol as written
- Active alcohol or substance abuse (Past 5 Years)
- Positive toxicology result from screening visit or chronic use of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Methadone, Opiate, THC, Cannabis, Tricyclics, or Oxycodone.
- Dyslipidemia (fasting triglycerides >500 mg/dL; low-density lipoprotein cholesterol (LDL-C) >190 mg/dL; total cholesterol >300 mg/dL);
- ALT >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
- Proteinuria (defined as > 1+) at screening
- Kidney disease (creatinine >1.6 mg/dl or estimated glomerular filtration rate <60 mL/min/1.73m2);
- Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; Human Immunodeficiency Virus (HIV); active hepatitis B or C undergoing antiviral therapy.
- Receiving active treatment (including monoclonal antibodies) for autoimmune disorders within the last 6 months;
- Hypothyroidism (sTSH>8) at screening or on thyroid replacement therapy
- Abnormal bleeding or coagulopathy (self-report) or history of a bleeding disorder or clotting abnormality
- 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;
- Previous bariatric or other surgery for obesity
- Females currently on hormone replacement therapy (HRT) less than 6 months
- Females with an irregular menstrual cycle
- Previous difficulty with lidocaine or other local anesthetic
- ACS symptoms:
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Translational Research Institute
Orlando, Florida, 32804
Recruitment Department, 407-303-7100, Fh.tri.recruitment@adventhealth.com
About this study
Official title: Determining Cell- and Spatially-distinct Skeletal Muscle Transcriptional Aberrations With Insulin Resistance
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
- Conditions
- Insulin Resistance
- Being tested
- VO2 Max, DEXA, Peripheral Microvascular Reactivity, Skeletal Muscle Insulin Sensitivity, Non-Oxidative Glucose Disposal
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VO2 MaxOther
Aerobic Fitness determined by measuring maximal volume of oxygen consumed (VO2max) during a stationary bicycle exercise test.
DEXAOther
DEXA scans will be performed to measure body fay and estimate muscle mass.
Peripheral Microvascular ReactivityOther
Post-occlusive reactive hyperemia (POHR) will be measured using Near Infrared Spectroscopy
Skeletal Muscle Insulin SensitivityOther
Skeletal Muscle Insulin Sensitivity will be assessed with a hyperinsulinemic -euglycemic clamp with stable glucose isotope tracers.
Non-Oxidative Glucose DisposalOther
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 BiopsyOther
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 group | Role | What they receive |
|---|---|---|
| Group A - Lean individuals with insulin sensitivity (IS-Lean) | Not described Receives: 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) | Not described Receives: 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) | Not described Receives: Other: VO2 Max; Other: DEXA; Other: Peripheral Microvascular Reactivity; Other: Skeletal Muscle Insulin Sensitivity; Other: Non-Oxidative Glucose Disposal; Other: Muscle tissue Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle insulin sensitivity
Skeletal muscle insulin sensitivity will be quantified with the HE clamp and compared between groups.
Measured: 6.5 hours
Skeletal muscle cell composition
Cell composition will be assessed with single cell RNA-seq and spatial transcriptomics and compared between the groups
Measured: 30 minutes
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start11 Jun 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie Whytock, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516509
- Sponsor's protocol ID
- 2334032
- Other IDs
- 1K99DK135915-01A1
- Acronym
- POINTS 2
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Cell- and Spatially-distinct Skeletal Muscle Transcriptional Aberrations With Insulin Resistance
- ClinicalTrials.gov ID
- NCT07516509
- Acronym / sponsor ID
- POINTS 2 / 2334032
- Conditions
- Insulin Resistance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (18 listed)
- All Groups
- Group A - Lean individuals with insulin sensitivity (IS-Lean)
- BMI 18-25 kg/m2
- Hemoglobin A1c ≤ 5.6% at screening
- Blood glucose level ≤ 140 mg/dL 2hr after a 75g oral glucose tolerance test
Key exclusion criteria (48 listed)
- 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
- Previous history of pulmonary emboli
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VO2 MaxAerobic Fitness determined by measuring maximal volume of oxygen consumed (VO2max) during a stationary bicycle exercise test. | Other | Group A - Lean individuals with insulin sensitivity (IS-Lean), Group B - Individuals with obesity and insulin sensitivity (IS-Obesity), Group C - Individuals with obesity and insulin resistance (IR-Obesity) |
| DEXADEXA scans will be performed to measure body fay and estimate muscle mass. | Other | Group A - Lean individuals with insulin sensitivity (IS-Lean), Group B - Individuals with obesity and insulin sensitivity (IS-Obesity), Group C - Individuals with obesity and insulin resistance (IR-Obesity) |
| Peripheral Microvascular ReactivityPost-occlusive reactive hyperemia (POHR) will be measured using Near Infrared Spectroscopy | Other | Group A - Lean individuals with insulin sensitivity (IS-Lean), Group B - Individuals with obesity and insulin sensitivity (IS-Obesity), Group C - Individuals with obesity and insulin resistance (IR-Obesity) |
| Skeletal Muscle Insulin SensitivitySkeletal Muscle Insulin Sensitivity will be assessed with a hyperinsulinemic -euglycemic clamp with stable glucose isotope tracers. | Other | Group A - Lean individuals with insulin sensitivity (IS-Lean), Group B - Individuals with obesity and insulin sensitivity (IS-Obesity), Group C - Individuals with obesity and insulin resistance (IR-Obesity) |
| Non-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. | Other | Group A - Lean individuals with insulin sensitivity (IS-Lean), Group B - Individuals with obesity and insulin sensitivity (IS-Obesity), Group C - Individuals with obesity and insulin resistance (IR-Obesity) |
| Muscle 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. | Other | Group A - Lean individuals with insulin sensitivity (IS-Lean), Group B - Individuals with obesity and insulin sensitivity (IS-Obesity), Group C - Individuals with obesity and insulin resistance (IR-Obesity) |
Primary outcome
Skeletal muscle insulin sensitivity
Time frame: 6.5 hours
Skeletal muscle insulin sensitivity will be quantified with the HE clamp and compared between groups.
Skeletal muscle cell composition
Time frame: 30 minutes
Cell composition will be assessed with single cell RNA-seq and spatial transcriptomics and compared between the groups
Cell and Region Specific Transcriptomic profiles
Time frame: 9 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katie Whytock, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Recruitment Department (407-303-7100, CFD.TRI.Recruitment@AdventHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle insulin sensitivity (time frame: 6.5 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.