Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

Tumour Clinical Trial

Official title:

Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779514
• Other study ID #: YJKY20220007
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Zhejiang Provincial People's Hospital
• Contact: Rui Hao
• Phone: 15957145619
• Email: hao61977[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tumour

Intervention

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.

Locations

Country	Name	City	State
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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