Semaglutide for Smoking Cessation in Patients With Diabetes: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Project success
研究概览
简要总结
To assess the feasibility of conducting a randomized controlled trial (RCT) to determine the effectiveness of semaglutide as an adjunct to combination NRT in supporting smoking cessation for patients with diabetes.
详细描述
Smoking and diabetes are well-established risk factors for cardiovascular disease (CVD) and leading causes of global morbidity and mortality. Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are primarily known for their role in managing diabetes, where they have demonstrated tremendous benefits in glucose control and weight loss. Approximately 12% of adults in the U.S. have ever taken a GLP-1 RA, with 6% currently using these medications. Beyond their primary focus, emerging evidence shows improved clinical outcomes such as Major Adverse Cardiovascular Events (MACE) and Obstructive Sleep Apnea (OSA). Recent research explores the potential role of GLP-1 RA in nicotine addiction. These medications suppress nicotine-induced dopamine release in the nucleus, which supports the exploration of GLP-1 RA therapies for nicotine dependence. Additionally, GLP-1 RA stimulates insulin secretion and reduces energy intake, addressing the common concern of post-cessation weight gain.
While GLP-1 RA have been extensively studied for their effects on weight management, their impact on smoking cessation has only been investigated in a limited number of trials. High-quality evidence is needed using newer and more commonly used GLP-1 RA to assess their effect on smoking cessation and mitigating post-cessation weight gain. We plan to conduct a definitive RCT but need a pilot study to determine feasibility of recruitment, treatment adherence, attrition, and to provide a preliminary estimate of effect size (for sample size calculation).
Research question - Among individuals living with diabetes who smoke, does the addition of GLP-1 RA to combination NRT result in increased smoking cessation at 6-month follow-up?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years or older) with type 2 diabetes
- •Currently residing in Ontario
- •Smoke at least five cigarettes per day and willing to reduce or quit smoking within the next 6 months
- •Stable HbA1c ≥7.0% - 10% with no more than a 1% change over the last 3 to 6 months.
- •Have not used GLP-1 receptor agonists in the past six months.
- •Able to provide informed consent
排除标准
- •Pregnant or breastfeeding individuals
- •Contraindication to NRT or GLP-1 RA.
- •Current daily use of NRT or a GLP1 RA.
- •Use of bupropion, cytisine, and varenicline within the last 7 days.
- •Use of a DPP-IV inhibitor within the last 7 days.
- •Initiation of a new diabetes medication within the last 3 months.
- •As per the product monograph, participants with the following diagnoses or disorders will be excluded;
- •Personal or family history of medullary thyroid cancer
- •Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
- •Diabetic ketoacidosis
- •Type I diabetes
- •Acute pancreatitis or pancreatic cancer
- •Acute, chronic or end-stage renal failure
- •Tachyarrhythmias
- •Unable to engage in follow-up for any reason (for example an acute mental illness, cognitive impairment, unable to speak English or French).
- •Other conditions deemed by the study team to interfere with participation or outcomes in the opinion of the study investigator (for example acutely unwell, life expectancy less than 1 year).
研究组 & 干预措施
Intervention
Semaglutide + Combination NRT for up to 6 months
干预措施: Semaglutide (Drug)
Intervention
Semaglutide + Combination NRT for up to 6 months
干预措施: Nicotine replacement (Drug)
Control
Combination NRT for up to 6 months
干预措施: Nicotine replacement (Drug)
结局指标
主要结局
Project success
时间窗: 12 months
Feasibility will be assessed to provide insights into the potential for a larger trial. Successful completion of this pilot will indicate that a full-scale study is both viable and likely to yield meaningful results. To measure this, the total number of people enrolled will be compared to the total number of people approached to participate.
次要结局
- Smoking status(6 months)
- Blood glucose score(6, and 12 months)
- Height(6, and 12 months)
- Weight(6, and 12 months)
- Waist circumference(6, and 12 months)
- Smoking status(6 months)
- Blood glucose score(6, and 12 months)
- Height(6, and 12 months)
- Weight(6, and 12 months)