Effect of Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Stimulation on Smoking Consumption in Type 2 Diabetes Patients

NCT06924697 | Enrolling By Invitation

• 1 other identifier: EC.D(BG).025.04.0
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Nicotine Dependence, Cigarettes

Keywords

clinical pharmacology; functional magnetic resonance imaging; smoking cessation; Diabetes Mellitus, Type 2; GLP-1 receptor agonist

Outcome Measures

Primary Outcomes (1)

• Fagerstrom Test of Nicotine Dependence (FTND) scores

  To evaluate smoking behavior and nicotine dependence before and after treatment, the Fagerström Test for Nicotine Dependence (FTND) will be administered at weeks 0, 1, 4, 12, and 24. Patient scores will be recorded.

  From enrollment to the end of treatment at 24 weeks.At weeks 0 and 24

Secondary Outcomes (5)

• Functional MRI changes

  From enrollment to the end of treatment at 24 weeks.At weeks 0 and 24

• Laboratory testing

  From enrollment to the end of treatment at 24 weeks.At weeks 0, 12, and 24

• Exhaled Carbon Monoxide (CO) Test

  From enrollment to the end of treatment at 24 weeks.At weeks 0, 12, and 24

• Adverse reactions

  From enrollment to the end of treatment at 24 weeks.At weeks 0, 4, 12, and 24

• BMI

  From enrollment to the end of treatment at 24 weeks.At weeks 0, 4, 12, and 24

Study Arms (2)

GLP-1 group

EXPERIMENTAL

Drug: Application of GLP-1RAs drugs

DPP-4i group

ACTIVE COMPARATOR

Drug: DPP-4i group

Interventions

Application of GLP-1RAs drugs DRUG

The pharmacological intervention will be given as an add-on to the standardised psychosocial T2DM treatment paradigm. Patients self-inject Semaglutide once a week or use other GLP-1RAs

GLP-1 group

DPP-4i group DRUG

The pharmacological intervention will be given as an add-on to the standardised psychosocial T2DM treatment paradigm. Patients took the DPP-4i according to their actual needs.

DPP-4i group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of type 1 diabetes or other specific types of diabetes.
• Presence of diabetic ketoacidosis or severe diabetic complications.
• 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.
• Poor adherence or inability to attend scheduled follow-up visits.
• 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.
• Contraindications to magnetic resonance imaging (MRI), such as metallic implants, pacemakers, or claustrophobia.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Department of Endocrinology, East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai

Shanghai, Shanghai Municipality, 200120, China

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• jun Song, doctoral degree

  East Hospital, Tongji University School of Medicine, Shanghai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: April 11, 2025
• Study Start: June 21, 2025
• Primary Completion: January 11, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study concludes, IPD will be available.Data will be available for a period of five years following the completion of the study.
• Access Criteria: Eligible researchers must submit a detailed research plan, which will be reviewed by the principal investigator before data access is granted. To ensure data security and formal communication, all data-sharing matters must be arranged via the institutional telephone number +86-21-38804518. After approval, the institution will provide the information to the relevant applicants. Personal email addresses will not be accepted as official contact methods.

Locations

CN (1)