Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

Study Overview
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Brief Summary
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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

Official Title
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Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

Conditions
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Tumour

Intervention / Treatment
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* Drug: Mirabegron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health Volunteers Sign the informed consent before the study, and fully understand the content, process and possible adverse events. Both men and women, aged 18-75 years (including the boundary value) . Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value). Tumor patients Sign the informed consent before the study, and fully understand the content, process and possible adverse events. Tumor bearing and not in the period of chemotherapy and targeted drug intervention). Both men and women, aged 18-75 years (including the boundary value) . Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value). 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. The expected survival is 3 months or more. Exclusion Criteria: Health Volunteers and Tumor patients A history of tuberculosis infection. 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). Women who are pregnant or breastfeeding. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The growth of brown adipose tissue by PET-CT | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirabegron, brown adipose tissue