Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

• Sponsor: Zhejiang Provincial People's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05779514
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 16.4
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Tumour	Drug: Mirabegron	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Mirabegron on Promoting Brown Adipose Tissue Activation
• Actual Study Start Date: Aug 18, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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≥1.5109/L; PLT≥50109/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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China	030000

Sponsors and Collaborators

• Zhejiang Provincial People's Hospital

Investigators

• Study Chair: Minghua Ge, Doctor, Institution Affiliation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhejiang Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT05779514
• Other Study ID Numbers: YJKY20220007
• First Posted: Mar 22, 2023
• Last Update Posted: Mar 22, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhejiang Provincial People's Hospital: brown adipose tissue; Mirabegron
• Additional relevant MeSH terms: Mirabegron

Study Results

No Results Posted as of Mar 22, 2023