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Clinical Trial Details

Trial ID: L4348
Source ID: NCT01926041
Associated Drug: Varenicline For Tobacco Smoking Cessation
Title: The Effectiveness of Smoking Cessation in Prediabetic Smokers
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01926041/results
Conditions: Diabetes Mellitus|Cigarette Smoking|Prediabetes
Interventions: DRUG: Varenicline for tobacco smoking cessation|BEHAVIORAL: Individualized counseling about both smoking cessation and weight control techniques
Outcome Measures: Primary: 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: Number of Participants With Regression to Normoglycemia, Participants who regress to normoglycemia should met all the following conditions for more than six months and maintained such status until the study end: 1) plasma glucose \<5.6 mmol/L (100 mg/dL) in the fasting state; 2) plasma glucose \<7.8 mmol/L (140 mg/dL) two hours after a 75-g oral glucose load; or 3) HbA1c\<39 mmol/mol (5.7%), in the absence of antidiabetic drugs., Up to 5 years|Major Adverse Cardiac Events, Cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke diagnosed by specialists according to medical records, At 10 years (between 2022 and 2026)|Chronic Kidney Disease Progression, Each participant is evaluated for the renal outcome every six months and at 10 years. Defined as progression to macroalbuminuria \[urinary albumin-to-creatinine ratio (UACR), \>300 mg of albumin per gram of creatinine\] for ≥ 3 months, or decrease in estimated glomerular filtration rate (eGFR) to \<60mL/min/1.73 m2 for ≥ 3 months, as calculated by the four-variable Modification of Diet in Renal Disease (MDRD) formula, and incident albuminuria for ≥ 3 months., Every 6 months and at 10 years (between 2022 and 2026)|NAFLD Progression, Each participant is evaluated for the steatohepatitic outcome using FIB-4 scores, BARD scores, liver stiffness measurement (LSM) every six months and at 10 years. A FIB-4 score \<1.45 means a low risk of advanced fibrosis, whereas patients with a score \>3.25 are likely to have advanced fibrosis. A BARD score of 2-4 was associated with an OR for advanced fibrosis of 17 (CI 9.2-31.9) and a negative predictive value of 96%. LSM is useful to exclude advanced NASH fibrosis with a high negative predictive value (at a cutoff \<7 kPa). Ref: FIB-4 scores (www.mdcalc.com/fibrosis-4-fib-4-index-liver-fibrosis); BARD scores (www.mdcalc.com/bard-score-nafld-fibrosis);, Every 6 months and at 10 years (between 2022 and 2026)|Malignancy Incidence, Incident malignancies based on medical records are accessed at 10 years, confirmed by national cancer registry system., At 10 years (between 2022 and 2026)|All-Cause Mortality, Deaths are ascertained at 10 years by computer linkage to the national death registry (death certificates were created by the Ministry of Health and Welfare, Taiwan) using ID numbers and these death certificates have been validated., At 10 years (between 2022 and 2026)|HbA1c Change Between Baseline and 6 Months, The HbA1c change (in percentage of HbA1c) was calculated from values between baseline and 6 months., Baseline and 6 months | Other: 10-year Type 2 DM Risk, This outcome will be collected between 2022 and 2026., At 10 years|10-year Probability of Regression to Normoglycemia, This outcome will be collected between 2022 and 2026., At 10 years
Sponsor/Collaborators: Sponsor: National Taiwan University Hospital | Collaborators: Ministry of Science and Technology, Taiwan
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 589
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2013-08-01
Completion Date: 2026-12-31
Results First Posted: 2023-02-22
Last Update Posted: 2024-04-30
Locations: National Taiwan University Hospital and its Yunlin branch, Taipei, Department Of Family Medicine, 100, Taiwan
URL: https://clinicaltrials.gov/show/NCT01926041