NCT06924697Enrolling by invitation
Effect of Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Stimulation on Smoking Consumption in Type 2 Diabetes Patients
Effect of Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Stimulation on Smoking Consumption in Type 2 Diabetes Patients: Study Protocol of a Randomized, Parallel -Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Diabetes has become an increasingly serious global health issue. In 2024, approximately 537 million adults were living with diabetes, and this number is projected to rise to 783 million by 2045, representing a 46% increase. Against the backdrop of a growing global diabetes epidemic, smoking among individuals with diabetes poses a significant threat, further exacerbating clinical and public health burdens. Despite over 50 years of tobacco control efforts, smoking remains one of the greatest public health threats in history, causing more than 8 million deaths annually worldwide. Among these, over 7 million deaths result from direct tobacco use, while approximately 1.3 million deaths are attributed to secondhand smoke exposure. Recent studies have shown that smoking increases the risk of developing prediabetes and diabetes. Moreover, individuals with diabetes who smoke have a higher risk of all-cause mortality, worsened chronic diabetic complications, an increased likelihood of developing cancer and cardiovascular diseases, and greater difficulty in glycemic control. Despite substantial evidence highlighting the detrimental effects of smoking on individuals with diabetes, national surveys from the 1990s indicated similar smoking prevalence rates between individuals with and without diabetes (27.3% and 25.9%, respectively). Although various smoking cessation methods are available, the success rate of quitting remains low, necessitating novel intervention strategies. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are widely used in the treatment of type 2 diabetes. They exert hypoglycemic effects by stimulating insulin secretion in a glucose-dependent manner, inhibiting glucagon secretion, enhancing glucose uptake in muscle and adipose tissue, suppressing hepatic glucose production, delaying gastric emptying, and reducing appetite. Existing studies suggest that GLP-1 influences the brain's reward system, and GLP-1RAs have been shown to reduce nicotine dependence in animal models. Recent clinical research has demonstrated that GLP-1RAs can be used in combination with nicotine patches to facilitate smoking cessation. However, whether GLP-1RAs alone can directly promote smoking cessation in individuals with diabetes remains unclear. Therefore, this study aims to investigate the potential direct effects of GLP-1RAs on smoking cessation in patients with type 2 diabetes.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 16 Mar 2025
- Start date
- 21 Jun 2025
- Primary completion date
- 11 Jan 2026
- Lead sponsor
- Shanghai East Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06924697
What you commit to
- Study type: Interventional
- Planned participants: 46
- From 21 Jun 2025 to the primary completion date, 11 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to magnetic resonance imaging (MRI), such as metallic implants, pacemakers, or claustrophobia.
- \-
Other illness
- Diagnosis of type 1 diabetes or other specific types of diabetes.
- Patients with severe cardiovascular, hepatic, renal, neurological, immune, or hematological diseases.
- Presence of severe infections, malignancies, recent surgeries, or major trauma.
- A history of severe recurrent hypoglycemia.
- Severe gastrointestinal disorders, such as gastroparesis.
- A history of pancreatitis or a high risk of developing pancreatitis.
- Presence of severe psychiatric disorders, including schizophrenia, paranoid psychosis, bipolar disorder, or intellectual disability.
Other
- Presence of diabetic ketoacidosis or severe diabetic complications.
- Poor adherence or inability to attend scheduled follow-up visits.
Who the study is looking for
- Male patients aged 18-75 years.
- Diagnosis of type 2 diabetes mellitus (T2DM) based on the World Health Organization (WHO) criteria.
- A history of smoking for at least one year.
- Fagerström Test for Nicotine Dependence (FTND) score ≥4.
- Eligible for treatment with glucagon-like peptide-1 receptor agonists (GLP1-RAs) or dipeptidyl peptidase-IV (DPP-IV) inhibitors but have not previously used these medications.
- Patients who fully understand the study, voluntarily participate, and sign the informed consent form.
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology, East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
- Effect of glucagon-like peptide-1 receptor agonists on cigarette smoking consumption in type 2 diabetes patients: study protocol of a randomized, parallel -controlled clinical trial.Front Clin Diabetes Healthc · 2026 · PMID 41704542
This page is information, not medical advice. Discuss any trial with your doctor.