Trial Outcomes & Findings for The Effectiveness of Smoking Cessation in Prediabetic Smokers (NCT NCT01926041)

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

589 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention (FIT2 Program) A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.	Usual Care Usual care is provided for prediabetic smokers who decide not to join the FIT2 program. Usual care comprises interpretation of laboratory results and encouragement to quit smoking and initiate a therapeutic lifestyle change for T2D prevention at each visit.
Overall Study STARTED	279	310
Overall Study COMPLETED	270	262
Overall Study NOT COMPLETED	9	48

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effectiveness of Smoking Cessation in Prediabetic Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention (FIT2 Program) n=279 Participants A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.	Usual Care n=310 Participants Usual care is provided for prediabetic smokers who decide not to join the FIT2 program. Usual care comprises interpretation of laboratory results and encouragement to quit smoking and initiate a therapeutic lifestyle change for T2 diabetes mellitus (DM) prevention at each visit.	Total n=589 Participants Total of all reporting groups
Age, Continuous	53.0 years STANDARD_DEVIATION 10.5 • n=5 Participants	53.9 years STANDARD_DEVIATION 9.4 • n=7 Participants	53.5 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	51 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Male	232 Participants n=5 Participants	259 Participants n=7 Participants	491 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	279 Participants n=5 Participants	310 Participants n=7 Participants	589 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body mass index	26.0 kg/m^2 STANDARD_DEVIATION 3.23 • n=5 Participants	26.4 kg/m^2 STANDARD_DEVIATION 3.91 • n=7 Participants	26.2 kg/m^2 STANDARD_DEVIATION 3.61 • n=5 Participants
HbA1c	6.12 percentage of HbA1c STANDARD_DEVIATION 0.14 • n=5 Participants	6.11 percentage of HbA1c STANDARD_DEVIATION 0.19 • n=7 Participants	6.11 percentage of HbA1c STANDARD_DEVIATION 0.17 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: Intention-to-treat analysis

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.

Outcome measures

Outcome measures
Measure	Intervention (FIT2 Program) n=279 Participants A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.	Usual Care n=310 Participants Usual care comprises interpretation of laboratory results and encouragement to quit smoking and initiate a therapeutic lifestyle change for T2D prevention at each visit.
Number of Participants With New-onset Type 2 Diabetes Mellitus (DM)	83 Participants	134 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Intention-to-treat analysis.

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.

Outcome measures

Outcome measures
Measure	Intervention (FIT2 Program) n=279 Participants A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.	Usual Care n=310 Participants Usual care comprises interpretation of laboratory results and encouragement to quit smoking and initiate a therapeutic lifestyle change for T2D prevention at each visit.
Number of Participants With Regression to Normoglycemia	43 Participants	25 Participants

SECONDARY outcome

Timeframe: At 10 years (between 2022 and 2026)

Cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke diagnosed by specialists according to medical records

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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);

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 10 years (between 2022 and 2026)

Incident malignancies based on medical records are accessed at 10 years, confirmed by national cancer registry system.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 10 years (between 2022 and 2026)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Intention-to-treat analysis

The HbA1c change (in percentage of HbA1c) was calculated from values between baseline and 6 months.

Outcome measures

Outcome measures
Measure	Intervention (FIT2 Program) n=279 Participants A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.	Usual Care n=310 Participants Usual care comprises interpretation of laboratory results and encouragement to quit smoking and initiate a therapeutic lifestyle change for T2D prevention at each visit.
HbA1c Change Between Baseline and 6 Months	0.11 percentage of HbA1c Standard Deviation 0.15	0.12 percentage of HbA1c Standard Deviation 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: At 10 years

This outcome will be collected between 2022 and 2026.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 10 years

This outcome will be collected between 2022 and 2026.

Outcome measures

Outcome data not reported

POST_HOC outcome

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

The differences in systolic/diastolic blood pressure values (mmHg) calculated from the average automated office blood pressure (AOBP) and home blood pressure (HBP) readings are accessed every six months and at 10 years.

Outcome measures

Outcome data not reported

Adverse Events

Intervention (FIT2 Program)

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention (FIT2 Program) n=279 participants at risk A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.	Usual Care n=310 participants at risk Usual care is provided for prediabetic smokers who decide not to join the FIT2 program. Usual care comprises interpretation of laboratory results and encouragement to quit smoking and initiate a therapeutic lifestyle change for T2D prevention at each visit.
General disorders Fatigue	15.1% 42/279 • At 16 weeks and every 6 months, up to 9 years and 6 months	15.8% 49/310 • At 16 weeks and every 6 months, up to 9 years and 6 months
Psychiatric disorders Insomnia	16.1% 45/279 • At 16 weeks and every 6 months, up to 9 years and 6 months	17.1% 53/310 • At 16 weeks and every 6 months, up to 9 years and 6 months

Additional Information

Dr. Chien-Hsieh Chiang

National Taiwan University Hospital & College of Medicine

Phone: +88623123456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place