Clinical trial NCT06319183: The Regulatory Function of Inhaled Asthma Medication Salbutamol on Thermogenesis
Official title: The Regulatory Function of Inhaled Asthma Medication Salbutamol on Thermogenesis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Effect of Asthma Medication Salbutamol on Obesity
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Aged 20-40 years, with at least 15 males and 15 females;
2. After administering the drug, the heart rate, blood pressure, and blood components of the subjects will be tested;
3. 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;
4. 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);
5. Subjects who agree to participate in this clinical trial and sign a written informed consent form.

Exclusion Criteria:

1. Subjects with clinically significant major pulmonary diseases;
2. Subjects with other diseases associated with elevated eosinophil counts;
3. Individuals allergic to Salbutamol;
4. Individuals allergic to fluorocarbons used as propellants;
5. Patients with cardiovascular dysfunction, insufficient coronary artery supply, hypertension, diabetes, and hyperthyroidism;
6. Individuals allergic to other adrenergic receptor agonists;
7. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
8. Individuals with rare hereditary digestive system diseases - lactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
9. Other reasons deemed by the researcher as inappropriate for participation in the trial.

Primary outcomes:
measure: Temperature of Scapular Region
timeFrame: Eight hours
Secondary outcomes:
Other outcomes:
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