Diabetes Mellitus, Type 2NCT06924697
Effect of Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Stimulation on Smoking Consumption in Type 2 Diabetes Patients
A study testing Application of GLP-1RAs drugs and DPP-4i group in people with Diabetes Mellitus, Type 2 and Nicotine Dependence, Cigarettes, run by Shanghai East Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Nicotine Dependence, Cigarettes
- What is being tested?
- Application of GLP-1RAs drugs and DPP-4i group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Endocrinology, East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai
Shanghai, Shanghai Municipality, 200120
About this study
Official title: 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
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.
Read the detailed description
Diabetes has become an increasingly severe global health concern. In 2021, an estimated 537 million adults worldwide were living with diabetes, and this number is projected to rise to 783 million by 2045, reflecting a 46% increase. Against the backdrop of the rising global prevalence of diabetes, smoking has been identified as a major risk factor for its onset, as well as a contributor to poor glycemic control and the progression of chronic diabetes complications. Moreover, smoking is an independent risk factor for elevated HbA1c levels. It has been reported that for every additional 20 pack-years of smoking, HbA1c increases by 0.12%. A meta-analysis of 46 prospective studies revealed that smoking increases the risk of all-cause mortality in patients with diabetes by 48%, the risk of coronary heart disease by 54%, myocardial infarction by 52%, and stroke by 44%. Additionally, smoking has been linked to an increased incidence of proteinuria and diabetic nephropathy.
Despite over 50 years of global tobacco control efforts, smoking remains one of the greatest public health threats in history. Tobacco use is responsible for approximately 8 million deaths annually, with over 7 million attributed to direct smoking and around 1.3 million to second hand smoke exposure. Although numerous smoking cessation interventions are available, the success rate remains suboptimal, highlighting the need for novel strategies. Currently, a combination of pharmacotherapy and counseling is considered the most effective approach for smoking cessation. However, findings from two meta-analyses conducted in 2013 and 2016 suggest that outcomes remain unsatisfactory. The withdrawal symptoms and post-cessation weight gain associated with conventional smoking cessation methods are among the leading causes of relapse.
Patients with T2DM often experience increased hunger. Following smoking cessation, the appetite-suppressing effects of nicotine are diminished, leading to increased food intake. Additionally, smoking cessation may alter gut microbiota, further contributing to weight gain. However, weight gain does not negate the long-term benefits of smoking cessation, which significantly reduces the risk of cardiovascular diseases and all-cause mortality. When exploring novel smoking cessation therapies, it is essential to address both nicotine withdrawal syndrome and the adverse metabolic effects of smoking cessation, such as weight gain, to maximize cessation success rates.
Glucagon-like peptide-1 (GLP-1), a gut hormone, has garnered significant research interest. It is an incretin hormone secreted by intestinal L-cells in response to nutrient intake. GLP-1 acts on the hypothalamus to enhance satiety and reduce food intake while also delaying gastric emptying. GLP-1 receptor agonists (GLP-1RA) are widely used for the treatment of T2DM. They exert glucose-lowering effects by stimulating insulin secretion in a glucose-dependent manner, inhibiting glucagon secretion , increasing glucose uptake in muscle and adipose tissues, suppressing hepatic glucose production, delaying gastric emptying, and reducing appetite.
Furthermore, GLP-1 is implicated in the shared neurobiological mechanisms of addiction via the mesolimbic reward system. Endogenous GLP-1 is produced in the nucleus tractus solitarius (NTS) of the brainstem and acts as a neurotransmitter released in multiple brain regions involved in reward processing. This suggests that GLP-1 may modulate addiction-related behaviours by attenuating neural responses in reward-related brain regions. However, no studies have yet investigated the effects of GLP-1RA on smoking cessation in patients with T2DM. In particular, it remains unclear whether GLP-1RA, at standard therapeutic doses for T2DM, can simultaneously reduce nicotine dependence.
Neuroimaging studies have shown that chronic nicotine use induces cognitive, structural, and functional alterations in the brain. Functional imaging research has identified the insula as a critical region involved in smoking behaviour. A negative correlation has been observed between cortical thickness in insular subregions and nicotine dependence. Additionally, functional imaging studies have demonstrated a positive correlation between nicotine dependence and activation of the anterior and posterior insula in response to smoking-related cues. Recent research has further revealed a negative correlation between nicotine dependence and connectivity between the left and right dorsal and left ventral anterior insula and the superior parietal lobule (SPL), including the left precuneus. The insula has thus been identified as a potential target for nicotine dependence treatment. Moreover, the left praecuneus has been proposed as a neuroimaging biomarker for nicotine addiction, with regional homogeneity (ReHo) values in the right superior frontal gyrus and left praecuneus distinguishing nicotine-dependent individuals.
To date, no studies have investigated nicotine dependence in patients with T2DM. Based on these findings, we hypothesize that GLP-1RA may modulate neural responses in reward-processing regions of the brain, thereby reducing nicotine dependence and cigarette consumption in patients with T2DM.
- Being tested
- Application of GLP-1RAs drugs, DPP-4i group
- Keywords
- clinical pharmacology, functional magnetic resonance imaging, smoking cessation, Diabetes Mellitus, Type 2, GLP-1 receptor agonist
- Medical subject headings
- Diabetes Mellitus, Type 2, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of GLP-1RAs drugsDrug
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
DPP-4i groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 group | Experimental | Not described Receives: Drug: Application of GLP-1RAs drugs |
| DPP-4i group | Active comparator | Not described Receives: Drug: DPP-4i group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 24 weeks.At weeks 0 and 24
Secondary outcomes (5)
Functional MRI changes
fMRI will be conducted at weeks 0 and 24 to investigate potential treatment effects. Resting-state functional connectivity (rsFC) analysis will be performed to assess time-dependent consistency of blood oxygen level-dependent (BOLD) or perfusion fMRI signal fluctuations between different brain regions in the absence of explicit tasks, providing insights into brain activity. Changes in resting-state functional connectivity, structural connectivity, and brain morphology will be analysed in addiction-related brain regions, including the praecuneus, lingual gyrus, and paracentral lobule. All participants will undergo fMRI scans at baseline and after 24 weeks of treatment.
Measured: From enrollment to the end of treatment at 24 weeks.At weeks 0 and 24
Laboratory testing
Blood samples will be collected at baseline (week 0), week 12, and week 24 for the assessment of complete blood count, liver and kidney function, electrolytes, coagulation profile, HbA1c, lipid profile, thyroid function, proinsulin, insulin, and C-peptide levels. Urine samples will be collected at baseline (week 0), week 12, and the final visit (week 24) for urinalysis, with a particular focus on urinary albumin levels and the albumin-to-creatinine ratio for intergroup comparisons.
Measured: From enrollment to the end of treatment at 24 weeks.At weeks 0, 12, and 24
Exhaled Carbon Monoxide (CO) Test
Exhaled CO levels will be assessed at weeks 0, 12, and 24 to monitor smoking status.
Measured: From enrollment to the end of treatment at 24 weeks.At weeks 0, 12, and 24
Adverse reactions
At baseline (week 0), informed consent will be obtained from all participants. Following medical history collection and eligibility assessment based on inclusion and exclusion criteria, patients will be randomly assigned to either the GLP-1RA group or the DPP-4i group. Any adverse events occurring during the study period will also be documented.
Measured: From enrollment to the end of treatment at 24 weeks.At weeks 0, 4, 12, and 24
BMI
Measured: From enrollment to the end of treatment at 24 weeks.At weeks 0, 4, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start21 Jun 2025 (estimated)
- Primary completion11 Jan 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jun Song, doctoral degree, Study director, East Hospital, Tongji University School of Medicine, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924697
- Sponsor's protocol ID
- EC.D(BG).025.04.0
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient raw data, statistical analysis programs, and the study protocol.
Publications
Willenborg J, Menzel W, Vetten HJ, Maiss E. Molecular characterization of two alphacryptovirus dsRNAs isolated from Daucus carota. Arch Virol. 2009;154(3):541-3. doi: 10.1007/s00705-009-0314-z. Epub 2009 Jan 23. No abstract available.
PubMed 19165417Kondoh H, Takagi S, Nomura K, Okada TS. Transdifferentiation of putative neuronal cells of neural retina into lens: A demonstration by chick-quail chimeric cultures. Wilehm Roux Arch Dev Biol. 1983 Sep;192(5):256-261. doi: 10.1007/BF00848657.
PubMed 28305512Gomez LA, Patino PJ, Novaira HJ, Morales MM, Condino-Neto A. A single nucleotide polymorphism in the promoter region of theNCF-2 gene. Am J Hematol. 2007 Dec;82(12):1124-5. doi: 10.1002/ajh.21015. No abstract available.
PubMed 17712795Scanlon TC, Dostal SM, Griswold KE. A high-throughput screen for antibiotic drug discovery. Biotechnol Bioeng. 2014 Feb;111(2):232-43. doi: 10.1002/bit.25019. Epub 2013 Aug 29.
PubMed 23955804Zhang HB, Scheuring CF, Zhang M, Zhang Y, Wu CC, Dong JJ, Li Y. Construction of BIBAC and BAC libraries from a variety of organisms for advanced genomics research. Nat Protoc. 2012 Feb 16;7(3):479-99. doi: 10.1038/nprot.2011.456.
PubMed 22343430Gallmeier K, Becker E, Kirsten A, Wolke G, Manuwald O, Meyer H, Magnussen H, Nowak D, Heinrich J. Prediction of new-onset asthma and nasal allergy by skin prick test and RAST in a cohort of adults. Eur Respir J. 2014 Jan;43(1):92-102. doi: 10.1183/09031936.00012813. Epub 2013 Sep 13.
PubMed 24036244Fernandez Rodriguez R. Language, Science and Globalization in the Eighteenth Century. Ber Wiss. 2023 Mar;46(1):38-53. doi: 10.1002/bewi.202200040. Epub 2023 Mar 6.
PubMed 36876428Ismail E, Orlando G, Corradini ML, Amerio P, Romani GL, Merla A. Differential diagnosis of Raynaud's phenomenon based on modeling of finger thermoregulation. Physiol Meas. 2014 Apr;35(4):703-16. doi: 10.1088/0967-3334/35/4/703. Epub 2014 Mar 12.
PubMed 24622281Patinadan PV, Tan-Ho G, Choo PY, Low CX, Ho AHY. 'Food for Life and Palliation (FLiP)': a qualitative study for understanding and empowering dignity and identity for terminally ill patients in Asia. BMJ Open. 2021 Apr 13;11(4):e038914. doi: 10.1136/bmjopen-2020-038914.
PubMed 33849845Perez H, Tah JHM, Mosavi A. Deep Learning for Detecting Building Defects Using Convolutional Neural Networks. Sensors (Basel). 2019 Aug 15;19(16):3556. doi: 10.3390/s19163556.
PubMed 31443244Nielsen PA. Mutagenicity studies on complex environmental mixtures: selection of solvent system for extraction. Mutat Res. 1992 Jan-Mar;276(1-2):117-23. doi: 10.1016/0165-1110(92)90060-m.
PubMed 1370102Tao L, Pereira MA. Quantification of carvone, cineole, perillaldehyde, perillyl alcohol and sobrerol by isocratic high-performance liquid chromatography. J Chromatogr A. 1998 Jan 9;793(1):71-6. doi: 10.1016/s0021-9673(97)00867-4.
PubMed 9468652Lue NF, Kornberg RD. A possible role for the yeast TATA-element-binding protein in DNA replication. Proc Natl Acad Sci U S A. 1993 Sep 1;90(17):8018-22. doi: 10.1073/pnas.90.17.8018.
PubMed 8367459Kragh-Hansen U, Donaldson D, Jensen PH. The glycan structure of albumin Redhill, a glycosylated variant of human serum albumin. Biochim Biophys Acta. 2001 Nov 26;1550(1):20-6. doi: 10.1016/s0167-4838(01)00264-3.
PubMed 11738084Stewart DL, Cook LN, Rabalais GP. Successful use of extracorporeal membrane oxygenation in a newborn with herpes simplex virus pneumonia. Pediatr Infect Dis J. 1993 Feb;12(2):161-2. doi: 10.1097/00006454-199302000-00014. No abstract available.
PubMed 8426779
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06924697
- Acronym / sponsor ID
- EC.D(BG).025.04.0
- Keywords
- clinical pharmacology, functional magnetic resonance imaging, smoking cessation, Diabetes Mellitus, Type 2, GLP-1 receptor agonist
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 21 Jun 2025 (estimated)
- Primary completion
- 11 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 11 Apr 2025 (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.
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.
Detailed description
Diabetes has become an increasingly severe global health concern. In 2021, an estimated 537 million adults worldwide were living with diabetes, and this number is projected to rise to 783 million by 2045, reflecting a 46% increase. Against the backdrop of the rising global prevalence of diabetes, smoking has been identified as a major risk factor for its onset, as well as a contributor to poor glycemic control and the progression of chronic diabetes complications. Moreover, smoking is an independent risk factor for elevated HbA1c levels. It has been reported that for every additional 20 pack-years of smoking, HbA1c increases by 0.12%. A meta-analysis of 46 prospective studies revealed that smoking increases the risk of all-cause mortality in patients with diabetes by 48%, the risk of coronary heart disease by 54%, myocardial infarction by 52%, and stroke by 44%. Additionally, smoking has been linked to an increased incidence of proteinuria and diabetic nephropathy.
Despite over 50 years of global tobacco control efforts, smoking remains one of the greatest public health threats in history. Tobacco use is responsible for approximately 8 million deaths annually, with over 7 million attributed to direct smoking and around 1.3 million to second hand smoke exposure. Although numerous smoking cessation interventions are available, the success rate remains suboptimal, highlighting the need for novel strategies. Currently, a combination of pharmacotherapy and counseling is considered the most effective approach for smoking cessation. However, findings from two meta-analyses conducted in 2013 and 2016 suggest that outcomes remain unsatisfactory. The withdrawal symptoms and post-cessation weight gain associated with conventional smoking cessation methods are among the leading causes of relapse.
Patients with T2DM often experience increased hunger. Following smoking cessation, the appetite-suppressing effects of nicotine are diminished, leading to increased food intake. Additionally, smoking cessation may alter gut microbiota, further contributing to weight gain. However, weight gain does not negate the long-term benefits of smoking cessation, which significantly reduces the risk of cardiovascular diseases and all-cause mortality. When exploring novel smoking cessation therapies, it is essential to address both nicotine withdrawal syndrome and the adverse metabolic effects of smoking cessation, such as weight gain, to maximize cessation success rates.
Glucagon-like peptide-1 (GLP-1), a gut hormone, has garnered significant research interest. It is an incretin hormone secreted by intestinal L-cells in response to nutrient intake. GLP-1 acts on the hypothalamus to enhance satiety and reduce food intake while also delaying gastric emptying. GLP-1 receptor agonists (GLP-1RA) are widely used for the treatment of T2DM. They exert glucose-lowering effects by stimulating insulin secretion in a glucose-dependent manner, inhibiting glucagon secretion , increasing glucose uptake in muscle and adipose tissues, suppressing hepatic glucose production, delaying gastric emptying, and reducing appetite.
Furthermore, GLP-1 is implicated in the shared neurobiological mechanisms of addiction via the mesolimbic reward system. Endogenous GLP-1 is produced in the nucleus tractus solitarius (NTS) of the brainstem and acts as a neurotransmitter released in multiple brain regions involved in reward processing. This suggests that GLP-1 may modulate addiction-related behaviours by attenuating neural responses in reward-related brain regions. However, no studies have yet investigated the effects of GLP-1RA on smoking cessation in patients with T2DM. In particular, it remains unclear whether GLP-1RA, at standard therapeutic doses for T2DM, can simultaneously reduce nicotine dependence.
Neuroimaging studies have shown that chronic nicotine use induces cognitive, structural, and functional alterations in the brain. Functional imaging research has identified the insula as a critical region involved in smoking behaviour. A negative correlation has been observed between cortical thickness in insular subregions and nicotine dependence. Additionally, functional imaging studies have demonstrated a positive correlation between nicotine dependence and activation of the anterior and posterior insula in response to smoking-related cues. Recent research has further revealed a negative correlation between nicotine dependence and connectivity between the left and right dorsal and left ventral anterior insula and the superior parietal lobule (SPL), including the left precuneus. The insula has thus been identified as a potential target for nicotine dependence treatment. Moreover, the left praecuneus has been proposed as a neuroimaging biomarker for nicotine addiction, with regional homogeneity (ReHo) values in the right superior frontal gyrus and left praecuneus distinguishing nicotine-dependent individuals.
To date, no studies have investigated nicotine dependence in patients with T2DM. Based on these findings, we hypothesize that GLP-1RA may modulate neural responses in reward-processing regions of the brain, thereby reducing nicotine dependence and cigarette consumption in patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 group | Experimental | Drug: Application of GLP-1RAs drugs |
| DPP-4i group | Active comparator | Drug: DPP-4i group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Application of GLP-1RAs drugsThe 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 | Drug | GLP-1 group |
| DPP-4i groupThe 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. | Drug | DPP-4i group |
Primary outcome
Fagerstrom Test of Nicotine Dependence (FTND) scores
Time frame: From enrollment to the end of treatment at 24 weeks.At weeks 0 and 24
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.
5 secondary outcomes
Functional MRI changes
Time frame: From enrollment to the end of treatment at 24 weeks.At weeks 0 and 24
Laboratory testing
Time frame: From enrollment to the end of treatment at 24 weeks.At weeks 0, 12, and 24
Exhaled Carbon Monoxide (CO) Test
Time frame: From enrollment to the end of treatment at 24 weeks.At weeks 0, 12, and 24
Adverse reactions
Time frame: From enrollment to the end of treatment at 24 weeks.At weeks 0, 4, 12, and 24
BMI
Time frame: From enrollment to the end of treatment at 24 weeks.At weeks 0, 4, 12, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Results publication: PubMed 19165417Willenborg J, Menzel W, Vetten HJ, Maiss E. Molecular characterization of two alphacryptovirus dsRNAs isolated from Daucus carota. Arch Virol. 2009;154(3):541-3. doi: 10.1007/s00705-009-0314-z. Epub 2009 Jan 23. No abstract available.
- Results publication: PubMed 28305512Kondoh H, Takagi S, Nomura K, Okada TS. Transdifferentiation of putative neuronal cells of neural retina into lens: A demonstration by chick-quail chimeric cultures. Wilehm Roux Arch Dev Biol. 1983 Sep;192(5):256-261. doi: 10.1007/BF00848657.
- Results publication: PubMed 17712795Gomez LA, Patino PJ, Novaira HJ, Morales MM, Condino-Neto A. A single nucleotide polymorphism in the promoter region of theNCF-2 gene. Am J Hematol. 2007 Dec;82(12):1124-5. doi: 10.1002/ajh.21015. No abstract available.
- Results publication: PubMed 23955804Scanlon TC, Dostal SM, Griswold KE. A high-throughput screen for antibiotic drug discovery. Biotechnol Bioeng. 2014 Feb;111(2):232-43. doi: 10.1002/bit.25019. Epub 2013 Aug 29.
- Results publication: PubMed 22343430Zhang HB, Scheuring CF, Zhang M, Zhang Y, Wu CC, Dong JJ, Li Y. Construction of BIBAC and BAC libraries from a variety of organisms for advanced genomics research. Nat Protoc. 2012 Feb 16;7(3):479-99. doi: 10.1038/nprot.2011.456.
- Results publication: PubMed 24036244Gallmeier K, Becker E, Kirsten A, Wolke G, Manuwald O, Meyer H, Magnussen H, Nowak D, Heinrich J. Prediction of new-onset asthma and nasal allergy by skin prick test and RAST in a cohort of adults. Eur Respir J. 2014 Jan;43(1):92-102. doi: 10.1183/09031936.00012813. Epub 2013 Sep 13.
- Results publication: PubMed 36876428Fernandez Rodriguez R. Language, Science and Globalization in the Eighteenth Century. Ber Wiss. 2023 Mar;46(1):38-53. doi: 10.1002/bewi.202200040. Epub 2023 Mar 6.
- Results publication: PubMed 24622281Ismail E, Orlando G, Corradini ML, Amerio P, Romani GL, Merla A. Differential diagnosis of Raynaud's phenomenon based on modeling of finger thermoregulation. Physiol Meas. 2014 Apr;35(4):703-16. doi: 10.1088/0967-3334/35/4/703. Epub 2014 Mar 12.
- Results publication: PubMed 33849845Patinadan PV, Tan-Ho G, Choo PY, Low CX, Ho AHY. 'Food for Life and Palliation (FLiP)': a qualitative study for understanding and empowering dignity and identity for terminally ill patients in Asia. BMJ Open. 2021 Apr 13;11(4):e038914. doi: 10.1136/bmjopen-2020-038914.
- Results publication: PubMed 31443244Perez H, Tah JHM, Mosavi A. Deep Learning for Detecting Building Defects Using Convolutional Neural Networks. Sensors (Basel). 2019 Aug 15;19(16):3556. doi: 10.3390/s19163556.
- Results publication: PubMed 1370102Nielsen PA. Mutagenicity studies on complex environmental mixtures: selection of solvent system for extraction. Mutat Res. 1992 Jan-Mar;276(1-2):117-23. doi: 10.1016/0165-1110(92)90060-m.
- Results publication: PubMed 9468652Tao L, Pereira MA. Quantification of carvone, cineole, perillaldehyde, perillyl alcohol and sobrerol by isocratic high-performance liquid chromatography. J Chromatogr A. 1998 Jan 9;793(1):71-6. doi: 10.1016/s0021-9673(97)00867-4.
- Individual participant dataSharing planned: Yes. De-identified patient raw data, statistical analysis programs, and the study protocol.
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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.
jun Song, doctoral degree study director
East Hospital, Tongji University School of Medicine, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of GLP-1RAs drugs and DPP-4i group in people with Diabetes Mellitus, Type 2 and Nicotine Dependence, Cigarettes, run by Shanghai East Hospital at 1 site in China.
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 6 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fagerstrom Test of Nicotine Dependence (FTND) scores (time frame: From enrollment to the end of treatment at 24 weeks.At weeks 0 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06924697, which also lists 32 linked publications.
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 31 May 2025.