The Effectiveness of Smoking Cessation in Prediabetic Smokers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 589
- 试验地点
- 2
- 主要终点
- Number of Participants With New-onset Type 2 Diabetes Mellitus (DM)
研究概览
简要总结
Existing literature investigating the impact of smoking cessation on new-onset diabetes mellitus (DM) risk is conflicting.
Combing the need for smoking cessation and body weight self-management to prevent the progression of prediabetes stage into DM, with the public implementation of the second-generation cessation program, we aimed to study the effectiveness of the Fight Tobacco and Stay Fit (FIT2) program aiming at promoting smoking cessation and restricting post-cessation weight gain (PCWG) together in prediabetic smokers regarding long-term glycemic and DM-related health outcomes.
详细描述
Participants:
We expect to recruit study participants at National Taiwan University Hospital and its Yunlin branch, where a systematic identification system has been applied to classify the tobacco addiction status of every patient in outpatient clinics. This study invites identified current smokers to undergo screening tests between August 2013 to January 2017. All participants should give informed consent, with personal data protected. Only individuals aged 30 to 75 years are included. A history of diabetes, hypertension, Fagerström test for nicotine dependence, alcohol consumption, physical activity, depression, sleep quality, and current medications is collected through standardized personal interviews. Prediabetic participants are those who repeatedly have either of the following: 1) plasma glucose 100 to 125 mg/dL (5.6 to 6.9 mmol/L) in the fasting state; 2) plasma glucose 140 to 199 mg/dL (7.8 to 11.0 mmol/L) two hours after a 75-g oral glucose load; 3) glycosylated hemoglobin (A1C) 5.7% to 6.4%, in the absence of diabetic medications. Prediabetic participants who smoke ≥10 CPD for at least 6 months are classified as prediabetic smokers. Excluded are those with existing diagnosis of DM, thyroid diseases, acute cardiac conditions within 3 months, acute renal failure, chronic glomerulonephritis, polycystic kidney disease, mental health disorders ever diagnosed by psychiatrists, pregnancy, breast-feeding, malignancy; or current use of diabetic medications, smoking cessation medications, steroids, lithium or antipsychotics. Information about tobacco use, alcohol consumption, physical activity, depression, sleep quality, personal medical histories, and current medications is collected through standardized personal interviews and medical records. The study protocol was approved by the National Taiwan University Hospital Research Ethics Committee.
Sample size estimation We estimate to recruit at least 596 prediabetic smokers, 33% (199) of whom decide to join the intervention, to reach 90% power and a two-sided 95% CI for the detection of a 50% risk reduction, assuming 30% as the risk of incident T2D during follow-up in the usual care group.
Assignment, prospective follow-up, and analytic design The assignment of this trial is based on shared decision-making. At baseline, all eligible prediabetic smokers are asked if they would like to join the Fight Tobacco and Stay Fit (FIT2) program or just receive usual care. Beginning at enrollment, the smoking status, breath carbon monoxide levels, anthropometric indices, automated office and home blood pressures, and blood tests were recorded every six months. The intention-to-treat analysis is performed among all participants joining the FIT2 program and receiving usual care. The modified per-protocol analysis is adopted to compare participants with documented abstinence at prespecified study ends (e.g., 10 years) with the controls.
The FIT2 program and post-program abstinence:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 30 to 75 years
- •Prediabetic smokers
排除标准
- •existing diagnosis of DM or current use of diabetic medications
- •thyroid diseases
- •acute cardiac conditions within 3 months
- •acute renal failure, chronic glomerulonephritis, or polycystic kidney disease
- •mental health disorders ever diagnosed by psychiatrists
- •pregnancy or breast-feeding
- •malignancy
- •current use of smoking cessation medications, steroids, lithium, or antipsychotics.
研究组 & 干预措施
Intervention
A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.
干预措施: Varenicline for tobacco smoking cessation (Drug)
Intervention
A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.
干预措施: Individualized counseling about both smoking cessation and weight control techniques (Behavioral)
结局指标
主要结局
Number of Participants With New-onset Type 2 Diabetes Mellitus (DM)
时间窗: Up to 5 years
The primary outcome is type 2 DM, defined as having repeatedly at least one of the following criteria: 1) plasma glucose ≥126 mg/dL (7.0 mmol/L) in the fasting state; 2) plasma glucose ≥200 mg/dL (11.1 mmol/L) randomly with hyperglycemic symptoms or two hours after a 75-g oral glucose load; 3) A1C ≥6.5%;20 or under medications for physician-diagnosed type 2 DM.
次要结局
- Malignancy Incidence(At 10 years (between 2022 and 2026))
- Number of Participants With Regression to Normoglycemia(Up to 5 years)
- NAFLD Progression(Every 6 months and at 10 years (between 2022 and 2026))
- HbA1c Change Between Baseline and 6 Months(Baseline and 6 months)
- Major Adverse Cardiac Events(At 10 years (between 2022 and 2026))
- Chronic Kidney Disease Progression(Every 6 months and at 10 years (between 2022 and 2026))
- All-Cause Mortality(At 10 years (between 2022 and 2026))