The Effectiveness of Smoking Cessation in Prediabetic Smokers

NCT01926041 | Active Not Recruiting Results DMC

• 1 other identifier: 201303041RINB
• Study Type: interventional
• Target: 589
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Cigarette Smoking; Prediabetes

Keywords

community; preventive medicine; prediabetes; smoking cessation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With New-onset Type 2 Diabetes Mellitus (DM)

  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.

  Up to 5 years

Secondary Outcomes (7)

• Number of Participants With Regression to Normoglycemia

  Up to 5 years

• 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)

• NAFLD Progression

  Every 6 months and at 10 years (between 2022 and 2026)

• Malignancy Incidence

  At 10 years (between 2022 and 2026)

Other Outcomes (2)

• 10-year Type 2 DM Risk

  At 10 years

• 10-year Probability of Regression to Normoglycemia

  At 10 years

Study Arms (2)

Intervention

EXPERIMENTAL

A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.

Drug: Varenicline for tobacco smoking cessation; Behavioral: Individualized counseling about both smoking cessation and weight control techniques

Control

NO INTERVENTION

Usual care

Interventions

Varenicline for tobacco smoking cessation DRUG

The 16-week varenicline course conforms to real-practice government regulations in Taiwan.

Also known as: Varenicline (Champix)

Intervention

Individualized counseling about both smoking cessation and weight control techniques BEHAVIORAL

The FIT2 program also offers behavior coaching in diet and physical activity to restrict post-cessation weight gain, which is not covered in conventional smoking cessation services.

Also known as: Individualized behavior coaching

Intervention

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 30 to 75 years
• Prediabetic smokers

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital and its Yunlin branch

Taipei, Department of Family Medicine, 100, Taiwan

Location

Related Publications (13)

• 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.

  PMID: 23483176 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.

  PMID: 22966072 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.

  PMID: 1932883 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.

  PMID: 17008192 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.

  PMID: 22080588 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.

  PMID: 22531094 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.

  PMID: 23404868 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.

  PMID: 24425422 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.

  PMID: 24966591 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.

  PMID: 25205437 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.

  PMID: 26198192 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.

  PMID: 26871803 BACKGROUND

• 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.

  PMID: 34684360 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Cigarette Smoking; Prediabetic State; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

The selection bias could not be completely mitigated due to the allocation by shared decision-making in this study. Participants with high motivation to quit are more likely to join the FIT2 program than their counterparts. Indeed, this design conforms to pragmatic clinical practice. The use of a non-randomized control group reduces the threat to external validity, which limits the value of randomized controlled trials.

Results Point of Contact

• Title: Dr. Chien-Hsieh Chiang
• Organization: National Taiwan University Hospital & College of Medicine

jiansie@gmail.com

+88623123456

Study Officials

• Chien-Hsieh Chiang, MD, MPH

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 20, 2013
• Study Start: August 1, 2013
• Primary Completion: December 31, 2020
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 24, 2025
• Results First Posted: February 22, 2023

Record last verified: 2025-06

Locations

TW (1)