Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

March 9, 2023 updated by: Zhejiang Provincial People's Hospital
In previous preclinical studies, our group found that Mirabegron, a clinical drug, could activate brown adipose tissue and inhibit tumor growth in tumour-bearing mice.Investigators look forward to further evaluating the effect of Mirabegron-mediated brown adipose tissue activation, so as to provide new drug applications for clinical cancer prevention and treatment

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 030000
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health Volunteers

    1. Sign the informed consent before the study, and fully understand the content, process and possible adverse events.
    2. Both men and women, aged 18-75 years (including the boundary value) .
    3. Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value).

  • Tumor patients

    1. Sign the informed consent before the study, and fully understand the content, process and possible adverse events.
    2. Tumor bearing and not in the period of chemotherapy and targeted drug intervention).
    3. Both men and women, aged 18-75 years (including the boundary value) .
    4. Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value).
    5. Proper bone marrow and organ function, as defined below:HB≥80h/L; ANC≥1.5*109/L; PLT≥50*109/L; ALT≤3 upper limit of normal ( ULN ); AST≤3 ULN ; TBIL≤1.5 ULN.
    6. The expected survival is 3 months or more.

Exclusion Criteria:

  • Health Volunteers and Tumor patients

    1. A history of tuberculosis infection.
    2. Patients with contraindications to Mirabegron: allergic to Mirabegron or any of its excipients; Patients with poorly controlled severe hypertension(SBP≧180mmHg or/and DBP≧110mmHg).
    3. Women who are pregnant or breastfeeding.
    4. The subject may not be able to complete the study for other reasons or may not be able to participate in the study for other reasons judged by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The growth of brown adipose tissue
Drug: Mirabegron
Health Volunteers ：Mirabegron p.o. 28 days 100mg qd./ Tumor patients ：Mirabegron p.o. 28 days 100 mg qd or 200 mg qd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The growth of brown adipose tissue by PET-CT
Time Frame: Day 0 and Day 28
Growth of brown adipose tissue after 28 days of oral administration of Mirabegron was measured by standard uptake value (SUV) values measured by PET-CT .
Day 0 and Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood glucose and glucose tolerance test ( GTT ) by Hematological tests
Time Frame: Day 0 and Day 28
The change of glucose( mmol/L ) and glucose tolerance test( mmol/L ) after 28 days of oral administration of Mirabegron by Hematological tests .
Day 0 and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Provincial People's Hospital

Investigators

  • Study Chair: Minghua Ge, Doctor, Institution Affiliation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YJKY20220007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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