Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

Not Applicable

Recruiting

• Conditions: Tumour
• Interventions: Drug: Mirabegron

• Registration Number: NCT05779514
• Lead Sponsor: Zhejiang Provincial People's Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-18
• Study First Submitted: 2023-02-16
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-22
• Last Update Posted: 2023-03-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The growth of brown adipose tissue	Mirabegron	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 .

Trial Locations

Locations (1)

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China