Determining Cell- and Spatially-distinct Skeletal Muscle Transcriptional Aberrations in Insulin Resistance
POINTS 2
2 other identifiers
observational
36
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 8, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 15, 2026
April 1, 2026
2.5 years
April 1, 2026
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Skeletal muscle insulin sensitivity
Skeletal muscle insulin sensitivity will be quantified with the HE clamp and compared between groups.
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
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
9 months
Study Arms (3)
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)
Interventions
Aerobic Fitness determined by measuring maximal volume of oxygen consumed (VO2max) during a stationary bicycle exercise test.
DEXA scans will be performed to measure body fay and estimate muscle mass.
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.
Post-occlusive reactive hyperemia (POHR) will be measured using Near Infrared Spectroscopy
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.
Skeletal Muscle Insulin Sensitivity will be assessed with a hyperinsulinemic -euglycemic clamp with stable glucose isotope tracers.
Eligibility Criteria
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.
You may qualify if:
- All Groups
- 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
- 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)
- +3 more criteria
You may not qualify if:
- 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
- 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)
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AdventHealth Translational Research Institute
Orlando, Florida, 32804, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katie Whytock, PhD
Study Principal Investigator
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2026
First Posted
April 8, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04