drugset / Trial / NCT01926041
The Effectiveness of Smoking Cessation in Prediabetic Smokers
Active not recruiting
589 enrolled
National Taiwan University Hospital
Ministry of Science and Technology, Taiwan · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
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.
Timeline
- Start
- 2013-08-01
- Primary completion
- 2020-12-31
- Completion
- 2027-12-31
Publications
- Background Clair C, Rigotti NA, Porneala B, Fox CS, D'Agostino RB, Pencina MJ, Meigs JB. Association of smoking cessation and weight change with cardiovascular disease among adults with and without diabetes. JAMA. 2013 Mar 13;309(10):1014-21. doi: 10.1001/jama.2013.1644.
- Background Bergman BC, Perreault L, Hunerdosse D, Kerege A, Playdon M, Samek AM, Eckel RH. Novel and reversible mechanisms of smoking-induced insulin resistance in humans. Diabetes. 2012 Dec;61(12):3156-66. doi: 10.2337/db12-0418. Epub 2012 Sep 10.
- Background Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
- Background Cropsey KL, Eldridge GD, Weaver MF, Villalobos GC, Stitzer ML. Expired carbon monoxide levels in self-reported smokers and nonsmokers in prison. Nicotine Tob Res. 2006 Oct;8(5):653-9. doi: 10.1080/14622200600789684.
- Background Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.
- Background Chiang CH, Yang HI, Jen CL, Lu SN, Wang LY, You SL, Su J, Iloeje UH, Chen CJ; REVEAL-HBV Study Group. Association between obesity, hypertriglyceridemia and low hepatitis B viral load. Int J Obes (Lond). 2013 Mar;37(3):410-5. doi: 10.1038/ijo.2012.63. Epub 2012 Apr 24.
- Background Chiang CH, Lai JS, Hung SH, Lee LT, Sheu JC, Huang KC. Serum adiponectin levels are associated with hepatitis B viral load in overweight to obese hepatitis B virus carriers. Obesity (Silver Spring). 2013 Feb;21(2):291-6. doi: 10.1002/oby.20000.
- Background Chiang CH, Lee LT, Hung SH, Lin WY, Hung HF, Yang WS, Sung PK, Huang KC. Opposite association between diabetes, dyslipidemia, and hepatocellular carcinoma mortality in the middle-aged and elderly. Hepatology. 2014 Jun;59(6):2207-15. doi: 10.1002/hep.27014. Epub 2014 Apr 3.
- Background Chiang CH, Huang KC. Association between metabolic factors and chronic hepatitis B virus infection. World J Gastroenterol. 2014 Jun 21;20(23):7213-6. doi: 10.3748/wjg.v20.i23.7213.
- Background Chiang CH, Huang KC. Reply: To PMID 24425422. Hepatology. 2015 May;61(5):1763-4. doi: 10.1002/hep.27427. Epub 2015 Mar 23. No abstract available.
- Background Chang PH, Chiang CH, Ho WC, Wu PZ, Tsai JS, Guo FR. Combination therapy of varenicline with nicotine replacement therapy is better than varenicline alone: a systematic review and meta-analysis of randomized controlled trials. BMC Public Health. 2015 Jul 22;15:689. doi: 10.1186/s12889-015-2055-0.
- Background Chiang CH, Lu CW, Han HC, Hung SH, Lee YH, Yang KC, Huang KC. The Relationship of Diabetes and Smoking Status to Hepatocellular Carcinoma Mortality. Medicine (Baltimore). 2016 Feb;95(6):e2699. doi: 10.1097/MD.0000000000002699.
- Chiang CH, Sheu YH, Guo FR, Lin WW, Chen GR, Huang KC. Incorporating Post-Cessation Weight-Control Coaching into Smoking Cessation Therapy to Reduce Type 2 Diabetes Risk. Nutrients. 2021 Sep 25;13(10):3360. doi: 10.3390/nu13103360.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Varenicline | Small molecule | 1 mg | — |