Genetics of Skeletal Muscle Insulin Resistance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will perform euglycemic/hyperinsulinemic clamps with longitudinal skeletal muscle biopsies and advanced sequencing techniques (single-nucleus RNA-Seq and ATAC-Seq) to identify cell-type specific molecular changes linked to insulin signaling and glucose uptake. The study uses two muscle biopsies from the vastus lateralis per participant and monitors glucose and insulin levels closely while maintaining a target blood glucose around 100 mg/dL. Insulin is delivered at a fixed rate, and glucose infusion is adjusted to sustain euglycemia during the clamp. Tissue samples will be processed to isolate nuclei for transcriptomic and chromatin accessibility analyses to map insulin-regulated rQTLs. The design aims to elucidate how basal and insulin-stimulated genetic variations influence skeletal muscle metabolism.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Aspartate aminotransferase/Alanine transaminase (AST/ALT) \< 75
* Blood sodium 135 to 145 mEq/L
* Blood potassium 3.6 to 5.2 mmol/L\[MH1.1\]

Exclusion Criteria:

* 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
* 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

Where it's running

• Texas Diabetes Institute - University Health System, San Antonio, Texas 78207
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Luke Norton, PhD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Luke Norton, Ph.D
• Email: nortonl@uthscsa.edu
• Phone: 210-567-0739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.