Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

NCT05779514 | Unknown

• 1 other identifier: YJKY20220007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Tumour

Keywords

brown adipose tissue; Mirabegron

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• blood glucose and glucose tolerance test ( GTT ) by Hematological tests

  Day 0 and Day 28

Study Arms (1)

The growth of brown adipose tissue

EXPERIMENTAL

Drug: Mirabegron

Interventions

Mirabegron DRUG

Health Volunteers ：Mirabegron p.o. 28 days 100mg qd./ Tumor patients ：Mirabegron p.o. 28 days 100 mg qd or 200 mg qd.

The growth of brown adipose tissue

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 030000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

mirabegron

Study Officials

• Minghua Ge, Doctor

  Institution Affiliation

  STUDY CHAIR

Central Study Contacts

Rui Hao

CONTACT

15957145619; hao61977@163.com

Jiajie Xu

CONTACT

13600517252; zjsrmyygcp@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 22, 2023
• Study Start: August 18, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

CN (1)