Early Phase 1
N=27
Age Comparisons of Exercising Muscle O2 Supply in Healthy Adults: Effects of Esmolol Infusion
Aging
Bottom Line
View on ClinicalTrials.gov: NCT04181606 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Tissue Saturation Index (TSI) - Active Leg Muscle — -5.1; -3.1; -8.7; -6.3 % Total Labile Signal
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Esmolol infusion (Drug); Saline infusion (Drug); Pre exercise baseline (Other); Isometric handgrip exercise (Other); Semi-recumbent cycling (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- David N. Proctor, PhD
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tissue Saturation Index (TSI) - Active Leg Muscle |
-5.1; -3.1; -8.7; -6.3; -1.5; -0.5 | — |
| SECONDARY Tissue Saturation Index - Inactive Forearm Muscle |
-3.3; -1.3; -5.9; -2.3; -0.1; -0.5 | — |
| SECONDARY Systolic Blood Pressure |
105; 104; 119; 137; 134; 156 | — |
| SECONDARY Heart Rate |
64.5; 70.0; 106.3; 115.4; 123.1; 141.2 | — |
| SECONDARY Cardiac Output |
5.3; 5.9; 11.3; 12.6; 13.5; 15.9 | — |
| SECONDARY Diastolic Blood Pressure |
66; 63; 64; 59; 64; 62 | — |
| SECONDARY Mean Arterial Pressure |
79; 77; 82; 85; 87; 93 | — |
| SECONDARY Stroke Volume |
84; 86; 107; 110; 110; 114 | — |
| SECONDARY Systemic Vascular Conductance |
70; 82; 141; 154; 159; 179 | — |
| SECONDARY ∆HHb - Inactive Forearm |
8.6; 5.0; 13.5; 5.9; 2.9; -3.4 | — |
Summary
This study will test the central hypothesis that postmenopausal women will demonstrate increased oxygen extraction in active leg muscle during leg cycling exercise while receiving an infusion of Esmolol, a fast-acting β1 selective antagonist, when compared to premenopausal women
Eligibility Criteria
3.1 Inclusion Criteria
- Capable of giving informed consent
- Premenopausal women ages 18-35 years OR post-menopausal women ages 55-70 years
- Satisfactory medical history and physical exam, as determined by a Clinical Research Center (CRC) clinician
- Not currently taking medications affecting heart rate or contractility
- Fluent in written and spoken English
3.2 Exclusion Criteria
Participants who will not be studied are those who:
- Are less than 19 years of age or more than 70 years of age
- Are pregnant or lactating
- Are prisoners or institutionalized individuals or unable to consent
- Diagnosed renal failure (Creatinine >2.0 mg/dl)
- Diagnosed liver disease (ALT and aspartate aminotransferase {AST} 2 times normal)
- Diagnosed Reynaud's disease
- Have uncontrolled diabetes
- Have uncontrolled hypertension
- Have a left ventricular ejection fraction < 40%
- Have a recent history of unstable angina or myocardial infarction (<6 months), unstable angina, or use of nitrate medications within past 2 weeks
- Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers) 11. Diagnosed bleeding or clotting disorder or recent blood transfusion 12. Have asthma, history of thyroid issues or hyperkalemia 13. Known use of recreational drugs 14. Methylphenidate use
Data sourced from ClinicalTrials.gov (NCT04181606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.