Diabetes and Smoking Cessation: a Gender Oriented Intervention Trial
Smoking and diabetes are both major public health burden. They act synergistically on morbidity and mortality. Micro and macro-vascular complications are dramatically increased among diabetic smokers; however people with diabetes still smoke at equivalent rates as non-diabetics. There is lack of evidence regarding interventions for smoking cessation among individuals with diabetes and the small number of existent studies has yielded mixed results. Smokers with diabetes might have more difficulties to quit because of specific barriers linked to weight gain at cessation and consequences on diabetes control. Furthermore, diabetic smokers and health professionals seem to be unaware of the potential hazards of smoking and benefits of smoking cessation on diabetes. Gender and sex-related disparities are also present. Men and women have different perceived risks and concerns about quitting smoking and its metabolic consequences. The impact of smoking cessation on diabetes control and complications might also differ between men and women.
The aims of this proposal are to: 1) Assess the beliefs and needs of smokers with type 2 diabetes and health professionals regarding smoking cessation, 2) Design, tailor and pilot-test an innovative smoking cessation intervention to meet the needs of smokers with diabetes, sensitized to gender/sex specificities, 3) Assess the 12 month efficacy of a gender/diabetes tailored smoking cessation intervention in a population of smokers with type 2 diabetes, 4) Assess the impact of smoking cessation on anthropometric outcomes, diabetes control and biomarkers of insulin resistance and perform sex/gender analyses to assess if there is an interaction for sex.
To reach theses aims we plan to first conduct 3 focus groups of 10 participants (10 male and 10 female smokers with type 2 diabetes, 10 healthcare professionals of both sexes) and a survey among 200 type 2 diabetic smokers to assess the beliefs, concerns and needs regarding smoking cessation. We will use findings of the focus groups and survey to tailor to gender and diabetes specificities the content and mode of delivery of a standard smoking cessation intervention. It will combine evidence-based treatments – behavioral support and nicotine replacement therapy – with 8 group sessions over 12 weeks. We will then conduct a randomized controlled trial with 520 type 2 diabetic smokers (260 men and 260 women) who will be randomly assigned to the smoking cessation intervention vs. usual care. Usual care will consist of brief advice from a physician and a booklet on smoking cessation. The main outcome will be 12-month biochemically verified continuous smoking abstinence. We then will assess the effect of smoking cessation compared to continuing smoking on anthropometric variables (weight, body-mass index, waist circumference), diabetes control (HbA1c, fasting glucose, needs in antidiabetic drugs), insulin resistance using glucose clamp techniques and other biomarkers (lipid profile, inflammatory markers). Finally we will perform analyses stratified by sex for the main and secondary outcomes to assess if there are significant differences between men and women with diabetes regarding smoking abstinence and its metabolic consequences.
The understanding of metabolic and endocrinologic consequences of smoking cessation is central in order to better inform and motivate diabetic smokers. If effective such an intervention could be implemented more widely (effectiveness trial) and novel, gendered approaches could be used to prevent and change other health behaviors. The need of this work is great given the paucity of extant trials in this area, the significantly increased risk of morbidity and mortality associated with smoking and diabetes, the high prevalence of smoking among diabetics and the worldwide rapidly increasing rate of type 2 diabetes."
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