The Regulatory Function of Inhaled Asthma Medication Salbutamol on Thermogenesis

March 13, 2024 updated by: Junkun Jiang, Tongji University

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salbutamol
Drug: Salbutamol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Eight hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023tjdxsy045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

After the related articles are published, these data will be made available to other researchers for reference.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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