TumourNCT05779514
Effect of Mirabegron on Promoting Brown Adipose Tissue Activation
A study testing Mirabegron in people with Tumour, run by Zhejiang Provincial People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumour
- What is being tested?
- Mirabegron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 030000
Rui Hao, 15957145619, hao61977@163.com
Jiajie Xu, 13600517252, zjsrmyygcp@163.com
About this study
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
- Being tested
- Mirabegron
- Keywords
- brown adipose tissue, Mirabegron
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Health Volunteers ：Mirabegron p.o. 28 days 100mg qd./ Tumor patients ：Mirabegron p.o. 28 days 100 mg qd or 200 mg qd.
| Study group | Role | What they receive |
|---|---|---|
| The growth of brown adipose tissue | Experimental | Not described Receives: Drug: Mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Day 0 and Day 28
Secondary outcomes (1)
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 .
Measured: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start18 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minghua Ge, Doctor, Study chair, Institution Affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779514
- Sponsor's protocol ID
- YJKY20220007
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mirabegron on Promoting Brown Adipose Tissue Activation
- ClinicalTrials.gov ID
- NCT05779514
- Acronym / sponsor ID
- YJKY20220007
- Conditions
- Tumour
- Keywords
- brown adipose tissue, Mirabegron
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The growth of brown adipose tissue | Experimental | Drug: Mirabegron |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Health Volunteers
- Tumor patients
Key exclusion criteria (5 listed)
- Health Volunteers and Tumor patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronHealth Volunteers ：Mirabegron p.o. 28 days 100mg qd./ Tumor patients ：Mirabegron p.o. 28 days 100 mg qd or 200 mg qd. | Drug | The growth of brown adipose tissue |
Primary outcome
The growth of brown adipose tissue by PET-CT
Time frame: 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 .
1 secondary outcome
blood glucose and glucose tolerance test ( GTT ) by Hematological tests
Time frame: Day 0 and Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minghua Ge, Doctor study chair
Institution Affiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirabegron in people with Tumour, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Hao (15957145619, hao61977@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The growth of brown adipose tissue by PET-CT (time frame: Day 0 and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.