Trial · NCT01926041
The Effectiveness of Smoking Cessation in Prediabetic Smokers
NCT01926041, Not applicable, Active not recruiting, National Taiwan University Hospital; results first posted 2023-02-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. The Effectiveness of Smoking Cessation in Prediabetic Smokers. Trials, record NCT01926041. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01926041
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effectiveness of Smoking Cessation in Prediabetic Smokers
- NCT number
- NCT01926041
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 589 participants, actual
- Lead sponsor
- National Taiwan University Hospital
- Conditions
- Diabetes Mellitus, Cigarette Smoking, Prediabetes
- Interventions
- Varenicline for tobacco smoking cessation, Individualized counseling about both smoking cessation and weight control techniques
- First posted
- 2013-08-20
- Last updated
- 2026-07-24
- Results first posted
- 2023-02-22
- 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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With New-onset Type 2 Diabetes Mellitus (DM) | Up to 5 years | 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. |
| Secondary | Number of Participants With Regression to Normoglycemia | Up to 5 years | 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. |
| Secondary | Major Adverse Cardiac Events | At 10 years (between 2022 and 2026) | Cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke diagnosed by specialists according to medical records |
| Secondary | Chronic Kidney Disease Progression | 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. |
| Secondary | NAFLD Progression | 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); |
| Secondary | Malignancy Incidence | At 10 years (between 2022 and 2026) | Incident malignancies based on medical records are accessed at 10 years, confirmed by national cancer registry system. |
| Secondary | All-Cause Mortality | 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. |
| Secondary | HbA1c Change Between Baseline and 6 Months | Baseline and 6 months | The HbA1c change (in percentage of HbA1c) was calculated from values between baseline and 6 months. |
| Other | 10-year Type 2 DM Risk | At 10 years | This outcome will be collected between 2022 and 2026. |
| Other | 10-year Probability of Regression to Normoglycemia | At 10 years | This outcome will be collected between 2022 and 2026. |
Source ClinicalTrials.gov
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With New-onset Type 2 Diabetes Mellitus (DM) | Up to 5 years | Intention-to-treat analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Regression to Normoglycemia | Up to 5 years | Intention-to-treat analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Major Adverse Cardiac Events | At 10 years (between 2022 and 2026) | |||
| SECONDARY | Chronic Kidney Disease Progression | Every 6 months and at 10 years (between 2022 and 2026) | |||
| SECONDARY | NAFLD Progression | Every 6 months and at 10 years (between 2022 and 2026) | |||
| SECONDARY | Malignancy Incidence | At 10 years (between 2022 and 2026) | |||
| SECONDARY | All-Cause Mortality | At 10 years (between 2022 and 2026) | |||
| SECONDARY | HbA1c Change Between Baseline and 6 Months | Baseline and 6 months | Intention-to-treat analysis | percentage of HbA1c | MEAN |
| OTHER_PRE_SPECIFIED | 10-year Type 2 DM Risk | At 10 years | |||
| OTHER_PRE_SPECIFIED | 10-year Probability of Regression to Normoglycemia | At 10 years |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With New-onset Type 2 Diabetes Mellitus (DM) | Intervention (FIT2 Program) | 83 | Participants | ||
| Number of Participants With New-onset Type 2 Diabetes Mellitus (DM) | Usual Care | 134 | Participants | ||
| Number of Participants With Regression to Normoglycemia | Intervention (FIT2 Program) | 43 | Participants | ||
| Number of Participants With Regression to Normoglycemia | Usual Care | 25 | Participants | ||
| HbA1c Change Between Baseline and 6 Months | Intervention (FIT2 Program) | 0.11 | Standard Deviation 0.15 | percentage of HbA1c | |
| HbA1c Change Between Baseline and 6 Months | Usual Care | 0.12 | Standard Deviation 0.14 | percentage of HbA1c |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention (FIT2 Program) | 279 | |
| Overall Study | STARTED | Usual Care | 310 | |
| Overall Study | COMPLETED | Intervention (FIT2 Program) | 270 | |
| Overall Study | COMPLETED | Usual Care | 262 | |
| Overall Study | NOT COMPLETED | Intervention (FIT2 Program) | 9 | |
| Overall Study | NOT COMPLETED | Usual Care | 48 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Intervention (FIT2 Program) | 42 | 279 | |
| other | Fatigue | General disorders | Usual Care | 49 | 310 | |
| other | Insomnia | Psychiatric disorders | Intervention (FIT2 Program) | 45 | 279 | |
| other | Insomnia | Psychiatric disorders | Usual Care | 53 | 310 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention (FIT2 Program) | 0 | 279 |
| Total, all-cause mortality | Usual Care | 0 | 310 |
| Total, other adverse events | Intervention (FIT2 Program) | 50 | 279 |
| Total, other adverse events | Usual Care | 65 | 310 |
| Total, serious adverse events | Intervention (FIT2 Program) | 0 | 279 |
| Total, serious adverse events | Usual Care | 0 | 310 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention (FIT2 Program) vs Usual Care: Number of Participants With New-onset Type 2 Diabetes Mellitus (DM) | Trial comparisons |
| Intervention (FIT2 Program) vs Usual Care: Number of Participants With Regression to Normoglycemia | Trial comparisons |
| Intervention (FIT2 Program) vs Usual Care: deaths from any cause | Trial comparisons |
| Intervention (FIT2 Program) vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01926041
GET https://conductscience.org/api/trials/v1/NCT01926041/registered