Tumour
Conditions
Keywords
brown adipose tissue, Mirabegron
Brief summary
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
Interventions
DRUGMirabegron
Health Volunteers ：Mirabegron p.o. 28 days 100mg qd./ Tumor patients ：Mirabegron p.o. 28 days 100 mg qd or 200 mg qd.
Sponsors
Zhejiang Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The growth of brown adipose tissue by PET-CT | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood glucose and glucose tolerance test ( GTT ) by Hematological tests | 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 . |
Countries
China
Contacts
Primary ContactRui Hao
Backup ContactJiajie Xu
Outcome results
None listed