ADRB3 Signaling Pathway in Human Adipose Tissue

Last updated: October 8, 2024
Sponsor: University of California, San Diego
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

Mirabegron

Clinical Study ID

NCT05634174
UC-MEDVH-01
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will examine the gene expression of the adrenergic Beta-3 receptor (ADRB3) regulation in human subcutaneous adipose tissue before and after treatment with mirabegron, an ADRB3 agonist. Gene expression will be compared across two groups, lean and obese participants. There will be a total of three study visits: Screening/Eligibility, Pre-Dose Adipose Tissue Biopsy and Post-Dose Adipose Tissue Biopsy. Participants will be given a single dose of 100mg oral mirabegron on the day of the Post-Dose Adipose Tissue Biopsy.The trial design is a single-center, phase 1, open-label, exploratory study to examine the adipocyte gene expression in adults treated with 1 dose of 100mg oral mirabegron.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form 2. Stated willingness tocomply with all study procedures and availability for the duration of the study
  2. Males and females 18-70 years old 4. Lean participants, defined as:
  • BMI <27 kg/m2

  • Normal glucose tolerance defined as fasting glucose less than 100 mg/dL orHbA1c of less than 5.7% at the time of the screening visit 5. Obese Insulinresistant participants, defined as:

  • BMI 30-40 kg/m2

  • Prediabetes defined as fasting glucose levels of 100 to 125 mg/dL or HbA1c of 5.7% to 6.4%

  • Agreement to adhere to Lifestyle Considerations (see section 5.3) throughoutstudy duration

Exclusion

Exclusion Criteria:

  1. Diabetes, defined as fasting glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, or diagnosis ofdiabetes 2. Pregnancy or lactation 3. Currently taking therapeuticanticoagulation which might increase risk of bleeding from fat biopsy (e.g.,warfarin, direct oral anticoagulants) 4. History of eating disorder 5.Currently enrolled in a weight-loss or weight-management program 6. On aspecial or prescribed diet for other reasons (e.g., Celiac disease) 7.Currently taking any medication that is meant for, or has known effect on,appetite 8. Any history of surgical intervention for weight management 9.Abnormal screening labs (renal dysfunction (eGFR < 30 ml/min/1.73 m2), anemia,hypo- or hyperthyroidism, coagulopathy, abnormal liver function (AST, ALT > 3xupper limit of normal) 10. Local or systemic infectious disease with fever orrequiring antibiotic within four weeks of screening visit 11. QTc intervalabove normal or the current use of any concomitant QT-prolonging drug 12. Aclinically significant abnormal ECG 13. Current addiction to alcohol orsubstances of abuse 14. Unwillingness or language barriers precluding adequateunderstanding or cooperation 15. Use of systemic corticosteroids or othermedication known to cause insulin resistance in previous six weeks prior to thescreening visit and throughout the study 16. Diagnosis of bladder outletobstruction or use of antimuscarinic medications for treatment of overactivebladder 17. Use of β-adrenergic receptor blockers or calcium channel blockers
  2. Heart disease including Coronary Artery Disease (CAD), Congestive HeartFailure (CHF), or cardiac arrhythmias 19. Uncontrolled sever hypertension (Defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥110 mm Hg) 20. Any other condition(s) that might reduce the chance ofobtaining study data, or that might cause safety concerns, or that mightcompromise the ability to give truly informed consent.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Mirabegron
Phase: 1
Study Start date:
August 01, 2023
Estimated Completion Date:
December 31, 2025

Study Description

The trial design is a single-center, phase 1, open-label, exploratory study to examine the adipocyte gene expression in adults treated with 1 dose of 100mg oral mirabegron.

This is an exploratory study to examine the effects of a single dose of mirabegron on adipocytes in insulin resistant obese individuals and lean controls. Approximately 40 patients over the age of 18 will be recruited for the study (20 obese individuals with insulin resistance and 20 lean controls).

There will be a total of three study visits: Screening/Eligibility, Pre-Dose Adipose Tissue Biopsy and Post-Dose Adipose Tissue Biopsy. All visits will take place at the ACTRI research clinic at UC San Diego. The Screening/Eligibility visit will involve collection of safety data and eligibility criteria, medical/medication history, physical exam, vitals, ECG and collection of urine and blood for safety laboratory analysis. The procedures completed at the Pre-Dose visit will be, vitals, re-review of medical history and changes since last visit, indirect calorimetry, an oral glucose tolerance test (OGTT), an adipose tissue biopsy, blood sample collection and study drug dispensing (one dose to be taken the morning of the following visit). The procedures completed at the Post-Dosing visit will be identical to those completed at the Baseline visit, except there will not be an OGTT at the Post-Dosing Visit.

Connect with a study center

  • UC San Diego Altman Clinical & Translational Research Institute

    La Jolla, California 92037
    United States

    Site Not Available

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