Effect of Asthma Medication Salbutamol on ObesityEarly Phase 1NCT06319183
The Regulatory Function of Inhaled Asthma Medication Salbutamol on Thermogenesis
A Early Phase 1 study testing Salbutamol in people with Effect of Asthma Medication Salbutamol on Obesity, run by Tongji University.
Trial summary
In recent years, obesity and its complications have severely threatened human health. Given the limited options for obesity treatment currently available, there is an urgent need to develop new drugs and therapeutic methods to alleviate patient suffering. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Asthma Medication Salbutamol on Obesity
- What is being tested?
- Salbutamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2025
- Phase
- Early Phase 1
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20-40 years, with at least 15 males and 15 females;
- After administering the drug, the heart rate, blood pressure, and blood components of the subjects will be tested;
- No history of asthma or diagnosed with bronchial asthma according to the "Chinese Guidelines for the Prevention and Treatment of Bronchial Asthma (2016 Edition)," and currently still in the persistent phase;
- During the lead-in period and treatment period of the study, able to discontinue the study drug and other beta-receptor agonist medications used for treating asthma (such as inhaled long-acting beta-receptor agonists);
- Subjects who agree to participate in this clinical trial and sign a written informed consent form.
Who cannot join
- Subjects with clinically significant major pulmonary diseases;
- Subjects with other diseases associated with elevated eosinophil counts;
- Individuals allergic to Salbutamol;
- Individuals allergic to fluorocarbons used as propellants;
- Patients with cardiovascular dysfunction, insufficient coronary artery supply, hypertension, diabetes, and hyperthyroidism;
- Individuals allergic to other adrenergic receptor agonists;
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- Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
- Individuals with rare hereditary digestive system diseases - lactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
- Other reasons deemed by the researcher as inappropriate for participation in the trial.
Trial locations and contacts
No sites are listed yet.
About this study
In recent years, obesity and its complications have severely threatened human health. Given the limited options for obesity treatment currently available, there is an urgent need to develop new drugs and therapeutic methods to alleviate patient suffering.
Mammalian adipose tissue is primarily divided into energy-storing white fat and energy-consuming brown fat. Physical activity, exposure to cold, and other factors induce the transformation of white fat into energy-consuming brown fat, a process known as adipose tissue browning. The occurrence of adipose tissue browning increases the body's energy expenditure and dissipates it in the form of heat, effectively mitigating the onset of obesity. Therefore, the regulatory mechanism of adipose tissue browning has become an important potential target for obesity treatment.
The main component of asthma medication is the β2 adrenergic receptor agonist, which can act on GPCR receptors on the surface of the tracheal smooth muscle through inhalation, causing bronchial dilation and thereby alleviating asthma symptoms. Preliminary experimental results have shown that pulmonary epithelial cells can secrete protein factors that regulate the browning process of adipose tissue, and the expression of these secretory factors is regulated by the cell surface GPCR receptor signaling pathway. Therefore, our goal is to validate the regulatory effect of the asthma medication salbutamol on adipose tissue browning through inhalation administration in humans, establishing a new function for asthma medication in obesity treatment.
- Being tested
- Salbutamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
We will recruit at least 15 male and 15 female volunteers, dividing study participants into two groups based on sex. Before administration, the temperature of the brown adipose tissue area in the scapular region of participants will be recorded using an infrared thermometer. Subsequently, participants will inhale the asthma medication salbutamol according to the safe dosage requirements (100ug). Eight hours later, the temperature changes in the brown adipose tissue area in the scapular region will be detected using an infrared thermometer. During the 8-hour waiting period, the participants' heart rate and blood pressure will be monitored; finally, we will draw 1 milliliter of venous blood from the arm of the participants for blood component analysis. The single trial process will last up to 8 hours, with no follow-up required.
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol | Experimental | Not described Receives: Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature of Scapular Region
The temperature of the brown adipose tissue area in the scapular region of participants will be recorded before and after salbutamol administration using an infrared thermometer
Measured: Eight hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Asthma Medication Salbutamol on ObesityStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junkun Jiang, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319183
- Sponsor's protocol ID
- 2023tjdxsy045
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Regulatory Function of Inhaled Asthma Medication Salbutamol on Thermogenesis
- ClinicalTrials.gov ID
- NCT06319183
- Acronym / sponsor ID
- 2023tjdxsy045
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 19 Mar 2024 (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 recent years, obesity and its complications have severely threatened human health. Given the limited options for obesity treatment currently available, there is an urgent need to develop new drugs and therapeutic methods to alleviate patient suffering.
Mammalian adipose tissue is primarily divided into energy-storing white fat and energy-consuming brown fat. Physical activity, exposure to cold, and other factors induce the transformation of white fat into energy-consuming brown fat, a process known as adipose tissue browning. The occurrence of adipose tissue browning increases the body's energy expenditure and dissipates it in the form of heat, effectively mitigating the onset of obesity. Therefore, the regulatory mechanism of adipose tissue browning has become an important potential target for obesity treatment.
The main component of asthma medication is the β2 adrenergic receptor agonist, which can act on GPCR receptors on the surface of the tracheal smooth muscle through inhalation, causing bronchial dilation and thereby alleviating asthma symptoms. Preliminary experimental results have shown that pulmonary epithelial cells can secrete protein factors that regulate the browning process of adipose tissue, and the expression of these secretory factors is regulated by the cell surface GPCR receptor signaling pathway. Therefore, our goal is to validate the regulatory effect of the asthma medication salbutamol on adipose tissue browning through inhalation administration in humans, establishing a new function for asthma medication in obesity treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salbutamol | Experimental | Drug: Salbutamol |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 20-40 years, with at least 15 males and 15 females;
- After administering the drug, the heart rate, blood pressure, and blood components of the subjects will be tested;
- No history of asthma or diagnosed with bronchial asthma according to the "Chinese Guidelines for the Prevention and Treatment of Bronchial Asthma (2016 Edition)," and currently still in the persistent phase;
- During the lead-in period and treatment period of the study, able to discontinue the study drug and other beta-receptor agonist medications used for treating asthma (such as inhaled long-acting beta-receptor agonists);
- Subjects who agree to participate in this clinical trial and sign a written informed consent form.
Key exclusion criteria (9 listed)
- Subjects with clinically significant major pulmonary diseases;
- Subjects with other diseases associated with elevated eosinophil counts;
- Individuals allergic to Salbutamol;
- Individuals allergic to fluorocarbons used as propellants;
- Patients with cardiovascular dysfunction, insufficient coronary artery supply, hypertension, diabetes, and hyperthyroidism;
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 |
|---|---|---|
| SalbutamolWe will recruit at least 15 male and 15 female volunteers, dividing study participants into two groups based on sex. Before administration, the temperature of the brown adipose tissue area in the scapular region of participants will be recorded using an infrared thermometer. Subsequently, participants will inhale the asthma medication salbutamol according to the safe dosage requirements (100ug). Eight hours later, the temperature changes in the brown adipose tissue area in the scapular region will be detected using an infrared thermometer. During the 8-hour waiting period, the participants' heart rate and blood pressure will be monitored; finally, we will draw 1 milliliter of venous blood from the arm of the participants for blood component analysis. The single trial process will last up to 8 hours, with no follow-up required. | Drug | Salbutamol |
Primary outcome
Temperature of Scapular Region
Time frame: Eight hours
The temperature of the brown adipose tissue area in the scapular region of participants will be recorded before and after salbutamol administration using an infrared thermometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Yes
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Salbutamol in people with Effect of Asthma Medication Salbutamol on Obesity, run by Tongji University.
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 5 inclusion and 9 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Junkun Jiang, Doctor (+86 19821813596, 1731099@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature of Scapular Region (time frame: Eight hours). 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 19 Mar 2024.