Insulin StimulatedNCT07780513
Genetics of Skeletal Muscle Insulin Resistance
A study testing Insulin 80mU/m2*min in people with Insulin Stimulated, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
In this study, the investigators will use euglycemic/hyperinsulinemic clamps, longitudinal skeletal muscle biopsies, and single nucleus ribonucleic acid sequencing (RNA-Seq) and assay for transposase-accessible chromatin using sequencing (ATAC- seq) to reveal cell type-specific molecular response quantitative trait… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Stimulated
- What is being tested?
- Insulin 80mU/m2*min
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Jul 2031
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females Age 18-75
- Body Mass Index (BMI) > 18
- Normal glucose tolerance as defined by:
- Fasting blood sugar < 100 mg/dL 2-hour Oral Glucose Tolerance Test (OGTT) < 140mg/dL Stable weight over the past 3 months defined as >±5% change in body weight
- Hemoglobin A1c < 5.7
- Creatinine < 2
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- Aspartate aminotransferase/Alanine transaminase (AST/ALT) < 75
- Blood sodium 135 to 145 mEq/L
- Blood potassium 3.6 to 5.2 mmol/L[MH1.1]
Who cannot join
- Urine albumin excretion>300mg/day
- Partial thromboplastin time (PTT) >35International normalized ratio (INR) > 1.2
- No oral corticosteroids for 1 month
- No Sodium-glucose co-transporter 2 (SGLT2) inhibitor for 3 months
- No glucagon-like peptide-1 (GLP-1) receptor agonist for 6 months
- Any anti-platelet or anti-coagulation medication other than as needed for Pain Management
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- No alcohol 4 days before the insulin clamp and biopsy procedure
- No acute structural knee injuries
- No Rheumatologic muscular or nervous system disease
- Pregnancy, Intentions to become pregnant, or Breastfeeding
- Blood Pressure >170/110
- Temperature > 100F
- Triglycerides > 400 by lipid panel
- Hemoglobin <10g/dL
- 1+ or greater Blood on Urinalysis
- 2+ or greater Protein on Urinalysis
- Electrocardiogram (EKG) abnormalities, including but not limited to ST elevations, T wave abnormalities, evidence of recent prior infarct
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
Texas Diabetes Institute - University Health System, San Antonio, Texas 78207
San Antonio, Texas, 78229
Luke Norton, Ph.D, 210-567-0739, nortonl@uthscsa.edu
nortonl@uthscsa.edu
About this study
Official title: Identification of Cell Type-Specific Insulin Responsive Quantitative Trait Loci (QTL) in Human Skeletal Muscle
In this study, the investigators will use euglycemic/hyperinsulinemic clamps, longitudinal skeletal muscle biopsies, and single nucleus ribonucleic acid sequencing (RNA-Seq) and assay for transposase-accessible chromatin using sequencing (ATAC- seq) to reveal cell type-specific molecular response quantitative trait loci (rQTLs) acutely regulated by insulin signaling and glucose uptake.
Read the detailed description
The study investigators seek to find the relationship between basal and insulin stimulated Quantitative trait loci (QTL's) by utilizing vastus lateralis muscle biopsies before and after a euglycemic/hyperinsulinemic clamp. Each participant will have a catheter placed into an antecubital vein for the infusion of all test substances. A second catheter will be inserted retrogradely into a vein on the dorsum of the hand, and the hand will be placed into a thermoregulated box heated to 45 to 50 degrees Celsius. All participants will receive an infusion of [3-3H]glucose. After a 2-h basal tracer equilibration period, participants will receive a prime-continuous insulin infusion at the rate of 80mU/m2*min. During the last 30 min of the basal equilibration period and throughout the insulin infusion, plasma samples will be taken at 5-10 min intervals for the determination of plasma glucose and insulin concentrations and tritiated glucose radioactivity. During the insulin infusion, a variable in-fusion of 20% glucose will be adjusted, based on the negative feedback principle, to maintain the plasma glucose concentration at ~100mg/dL with a coefficient of variation <5%. Skeletal muscle biopsies will be obtained from the vastus lateralis muscle approximately 1h prior to and at the end of the insulin clamp, and will be snap frozen in liquid nitrogen for nuclei isolation.
- Conditions
- Insulin Stimulated
- Being tested
- Insulin 80mU/m2*min
- Keywords
- Insulin, Skeletal muscle, Quantitative trait loci (QTL)
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin 80mU/m2*minOther
80mU/m2*min euglycemic-hyperinsulinemic clamp
| Study group | Role | What they receive |
|---|---|---|
| Insulin stimulated | Experimental | 80mU/m2*min euglycemic/hyperinsulinemic clamp Receives: Other: Insulin 80mU/m2*min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell type specific quantitative trait loci in skeletal muscle
Single nucleus ribonucleic acid sequencing (RNA-Seq) and assay for transposase-accessible chromatin using sequencing (ATAC- seq) will be used to reveal cell type-specific molecular response quantitative trait loci (QTLs) acutely regulated by insulin signaling and glucose uptake
Measured: Before and after insulin clamp (Baseline to approximately 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin StimulatedStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Norton, The University of Texas Health Science Center at San Antonio
- Investigators
- Luke Norton, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780513
- Sponsor's protocol ID
- STUDY00001627
- Other IDs
- R01DK145103
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant data will be deidentified prior to sharing with any external entity at the University of Michigan or the National Institute of Diabetes and Digestive and Kidney Diseases. Any results shared as summary result on ClinicalTrials.gov or in a publication will not have any participant identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Cell Type-Specific Insulin Responsive Quantitative Trait Loci (QTL) in Human Skeletal Muscle
- ClinicalTrials.gov ID
- NCT07780513
- Acronym / sponsor ID
- STUDY00001627
- Conditions
- Insulin Stimulated
- Keywords
- Insulin, Skeletal muscle, Quantitative trait loci (QTL)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 21 Aug 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.
In this study, the investigators will use euglycemic/hyperinsulinemic clamps, longitudinal skeletal muscle biopsies, and single nucleus ribonucleic acid sequencing (RNA-Seq) and assay for transposase-accessible chromatin using sequencing (ATAC- seq) to reveal cell type-specific molecular response quantitative trait loci (rQTLs) acutely regulated by insulin signaling and glucose uptake.
Detailed description
The study investigators seek to find the relationship between basal and insulin stimulated Quantitative trait loci (QTL's) by utilizing vastus lateralis muscle biopsies before and after a euglycemic/hyperinsulinemic clamp. Each participant will have a catheter placed into an antecubital vein for the infusion of all test substances. A second catheter will be inserted retrogradely into a vein on the dorsum of the hand, and the hand will be placed into a thermoregulated box heated to 45 to 50 degrees Celsius. All participants will receive an infusion of [3-3H]glucose. After a 2-h basal tracer equilibration period, participants will receive a prime-continuous insulin infusion at the rate of 80mU/m2*min. During the last 30 min of the basal equilibration period and throughout the insulin infusion, plasma samples will be taken at 5-10 min intervals for the determination of plasma glucose and insulin concentrations and tritiated glucose radioactivity. During the insulin infusion, a variable in-fusion of 20% glucose will be adjusted, based on the negative feedback principle, to maintain the plasma glucose concentration at ~100mg/dL with a coefficient of variation <5%. Skeletal muscle biopsies will be obtained from the vastus lateralis muscle approximately 1h prior to and at the end of the insulin clamp, and will be snap frozen in liquid nitrogen for nuclei isolation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin stimulated | Experimental | Other: Insulin 80mU/m2*min80mU/m2*min euglycemic/hyperinsulinemic clamp |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and Females Age 18-75
- Body Mass Index (BMI) > 18
- Normal glucose tolerance as defined by:
- Fasting blood sugar < 100 mg/dL 2-hour Oral Glucose Tolerance Test (OGTT) < 140mg/dL Stable weight over the past 3 months defined as >±5% change in body weight
- Hemoglobin A1c < 5.7
Key exclusion criteria (17 listed)
- Urine albumin excretion>300mg/day
- Partial thromboplastin time (PTT) >35International normalized ratio (INR) > 1.2
- No oral corticosteroids for 1 month
- No Sodium-glucose co-transporter 2 (SGLT2) inhibitor for 3 months
- No glucagon-like peptide-1 (GLP-1) receptor agonist for 6 months
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 |
|---|---|---|
| Insulin 80mU/m2*min80mU/m2*min euglycemic-hyperinsulinemic clamp | Other | Insulin stimulated |
Primary outcome
Cell type specific quantitative trait loci in skeletal muscle
Time frame: Before and after insulin clamp (Baseline to approximately 6 hours)
Single nucleus ribonucleic acid sequencing (RNA-Seq) and assay for transposase-accessible chromatin using sequencing (ATAC- seq) will be used to reveal cell type-specific molecular response quantitative trait loci (QTLs) acutely regulated by insulin signaling and glucose uptake
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 30 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual Participant data will be deidentified prior to sharing with any external entity at the University of Michigan or the National Institute of Diabetes and Digestive and Kidney Diseases. Any results shared as summary result on ClinicalTrials.gov or in a publication will not have any participant identifiers.
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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.
Luke Norton, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin 80mU/m2*min in people with Insulin Stimulated, run by The University of Texas Health Science Center at San Antonio 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 9 inclusion and 17 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 30 Oct 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 Luke Norton, Ph.D (210-567-0739, nortonl@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell type specific quantitative trait loci in skeletal muscle (time frame: Before and after insulin clamp (Baseline to approximately 6 hours)). 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 30 Oct 2026.