A Randomised Controlled International Multicentre Study Evaluating Changes in Metabolic Syndrome in Smokers With Type 2 Diabetes Mellitus After Switching From Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems: DIASMOKE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 576
- 试验地点
- 2
- 主要终点
- Change in Metabolic Syndrome Prevalence
研究概览
简要总结
Very little is known about the impact of combustion-free nicotine delivery systems (C-F NDS) on cardiovascular risk factors in T2DM patients who smoke. Data from clinical studies to identify any potential reduction in individuals' risk, relative to the risk of continued smoking, are needed.
This study aims to test the hypothesis that avoiding exposure to cigarette smoke toxicants may translate to measurable improvement in cardiovascular risk factors and functional parameters when T2DM patients who smoke switch to using C-F NDS compared with T2DM patients who continue to smoke conventional tobacco products.
The investigators propose a prospective 2-year multicenter randomized controlled trial (RCT) to evaluate changes in cardiovascular risk factors and functional parameters in diabetic smokers using C-F NDS and compared to those continuing cigarette smoking.
详细描述
This is a multicenter, controlled study utilizing a randomized switching design for cigarette smoking and C-F NDS use. The study will take place in one site in each of five countries. Three countries have so far agreed to participate: UK, Italy, Poland. An amendment will be submitted to the REC once the final two countries are signed up.
A volunteer population of adult smokers with T2DM will be recruited. Smokers will be randomized (1:2 ratio) to either continue to smoke their own cigarette brand (Study Arm A) or use C-F NDS (Study Arm B). The intended minimum number of participants in each arm by the end of the study is 147.
Before randomization, all smokers will be reminded of the risks associated with smoking and will be offered a free smoking cessation program according to standard local guidelines and depending on the local availability of antismoking services. Those who decline the invitation will be eligible for recruitment into the RCT.
Smokers are free to voluntarily quit smoking/C-F NDS and/or withdraw from the study at any time.
Duration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be required to satisfy all of the following criteria at the screening visit, unless otherwise stated:
- •Participants will be: 1.1. over 23 years of age
- •T2DM Patients will have: 2.1. body mass index (BMI) between 17.6 and 34.5 kg/m2, inclusive 2.2. body weight exceeding 50 kg (males) or 40 kg (females) 2.3 6.0\ 10 ng/mL or an exhaled breath CO (eCO) level \> 7 ppm at screening.
- •* Participants in Arm A who continue to smoke will be willing to use their own brand/type cigarettes.
- •* Participants in Arms B will be willing to use the study products (THP product or e-cigarette) provided to them during the study.
排除标准
- •Participants will be excluded at the screening visit based on the following criteria:
- •Female participants who are pregnant or breastfeeding. This will be confirmed at screening and at visit
- •Any female subject who becomes pregnant during this study will be withdrawn.
- •Participants with a history of recent acute decompensation of their disease requiring treatment within 4 weeks prior to visit
- •Participants who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to screening, as determined by the investigator.
- •Participants who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first product use.
- •Participants who have, or who have a history of, any clinically-significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the investigator or their appropriately qualified designee, would jeopardise the safety of the subject or impact on the validity of the study results.
- •Participants who regularly use any nicotine (e.g. e-cigarettes, NRT) or tobacco product (e.g. HTPs, oral smokeless) other than their own cigarettes within 14 days of screening.
- •At screening and prior to enrolment, all patients will be offered a locally available free smoking cessation program as per local guidelines. Those who express the intention of booking for the cessation program together with those who, at screening, are planning to quit smoking in the next 6 months, will not be recruited in the study. Patients taking part in the study will be informed that they are free to quit smoking and withdraw from the study at any time. Any subject who decides to quit smoking will be directed to local stop smoking services.
- •Withdrawal Criteria:
- •Patients may be withdrawn from the study prematurely for the following reasons:
- •subject experiences a severe adverse event (SAE). The appropriate SAE electronic Case Report Form (eCRF) page must be completed.
- •If any deviations occur during the conduct of the study, which cannot be corrected. All protocol deviations will be fully documented and considered for their effect on study objectives. Deviations that could lead to subject discontinuation from the study include:
- •deviations which could affect subject's safety (e.g. illness requiring treatment[s]) which in the clinical judgement of the investigator might invalidate the study by interfering with the allocated test product or the willingness of the subject to comply with the study activities.
- •deviations involving the use of any nicotine/tobacco products other than the intended conventional cigarettes (in Arm A) or (in Arm B).
- •If the subject is uncooperative, including non-attendance. In these cases, efforts should have been made by the investigator to ascertain the reason and to ensure the subject's attendance as soon as possible.
- •Subject's personal request: the subject could decide, at any moment of the study, to stop his/her participation.
- •Female participant becoming pregnant.
结局指标
主要结局
Change in Metabolic Syndrome Prevalence
时间窗: Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years
Percentage (%) change in Metabolic Syndrome Prevalence
次要结局
- Change in Blood Pressure(Change in blood pressure from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
- Change in Plasma Glucose(Change in plasma glucose from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
- Change in Triglycerides(Change in triglycerides from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
- Change in High-Density Lipoprotein (HDL)(Change in HDL from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
- Change in Waist Circumference(Change in waist circumference from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)