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Trial record 59 of 2034 for:    Smoking Cessation

The Effectiveness of Smoking Cessation in Prediabetic Smokers

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ClinicalTrials.gov Identifier: NCT01926041
Recruitment Status : Active, not recruiting
First Posted : August 20, 2013
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Diabetes mellitus (DM) has been established to contribute to cardiovascular comorbidities, malignancies and higher mortalities. The management of DM is not limited to aggressively controlling sugar levels after the diagnosis; instead, should be emphasized more on effective modification for prediabetics. Smoking cessation were also demonstrated to improve insulin resistance. Nowadays, the 2nd-generation cessation program in Taiwan brings higher accessibility. However, there is little evidence on the long-term health outcomes of combining smoking cessation and coach-assisted lifestyle change for the prediabetics in the community.

After the baseline assessment, all prediabetic smokers are provided with a standardized diet and lifestyle education, with prospective follow-up of smoking status, anthropometric indices, and blood tests. At each visit, all study subjects can choose to join the smoking cessation program. Both the smoking cessation group and self-management group are provided with individualized counseling and incentives to help reach the goals of at least a 7 percent weight loss. Cox regression will be used to investigate the effectiveness of smoking cessation and body weight self-management in prediabetics.

We hope this community-based prospective project will not only help strengthen the motivation of smoking cessation in prediabetic smokers but also contribute to community-based diabetes research in preventive medicine.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Cigarette Smoking Prediabetes Other: Smoking cessation clinics Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 446 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effectiveness of Smoking Cessation in Prediabetic Smokers
Study Start Date : August 2013
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smoking cessation
Participants who decide to attend the smoking cessation program will be referred to smoking cessation clinics at National Taiwan University Hospital and its Yunlin branch.
Other: Smoking cessation clinics
Participants in this group can receive their medications up to 16 weeks within one year. Each participant also receives counseling from a well-trained full-time research assistant for individualized smoking cessation techniques at each visit.

No Intervention: Self-management
Participants who decide not to attend the smoking cessation program are classified as self-management group.



Primary Outcome Measures :
  1. Diagnosis of diabetes mellitus by ADA criteria [ Time Frame: at least 3 years (from Aug 1, 2013) ]
    The primary outcome is 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 DM.


Secondary Outcome Measures :
  1. A1C Change and Regression to Normoglycemia [ Time Frame: at least 3 years (from Aug 1, 2013) ]
    Normoglycemia is defined as having all the following for over 3 months: 1) plasma glucose <100 mg/dL (5.6 mmol/L) in the fasting state; 2) plasma glucose <140 mg/dL (7.8 mmol/L) two hours after a 75-g oral glucose load; 3) A1C <5.7%, in the absence of diabetic medications.

  2. Diagnoses of cardiovascular events [ Time Frame: at least 3 years (from Aug 1, 2013) ]
    by specialists

  3. Chronic kidney disease progression [ Time Frame: at least 3 years (from Aug 1, 2013) ]
    including change in eGFR and microalbuminuria

  4. Chronic hepatitis or cirrhosis progression [ Time Frame: at least 3 years (from Aug 1, 2013) ]
    confirmed by ultrasonography or advanced image or pathology studies

  5. Malignancy incidence [ Time Frame: at least 3 years (from Aug 1, 2013) ]
    confirmed by national cancer registry system


Other Outcome Measures:
  1. All-cause mortality [ Time Frame: at least 3 years (from Aug 1, 2013) ]
    Deaths are ascertained by computer linkage to the national death registry (death certificates were created by the Department of Health, Taiwan) using ID numbers and these death certificates have been validated.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals aged from 30 to 75 years
  • Prediabetics (ADA criteria): including prediabetic smokers and non-smokers

Exclusion Criteria:

  • Acute cardiac conditions within 3months
  • Acute renal failure
  • Chronic glomerulonephritis
  • Polycystic kidney disease
  • Use of diabetic medications, steroids, lithium or antipsychotics
  • Pregnancy or breast-feeding
  • Malignancy.
  • The elderly adults visiting two or more hospitals due to multiple diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926041


Locations
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Taiwan
National Taiwan University Hospital and its Yunlin branch
Taipei, Department Of Family Medicine, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Ministry of Science and Technology, Taiwan
Investigators
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Principal Investigator: Chien-Hsieh Chiang, MD, MPH National Taiwan University Hospital

Publications:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01926041     History of Changes
Other Study ID Numbers: 201303041RINB
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

Keywords provided by National Taiwan University Hospital:
community
preventive medicine
prediabetes
smoking cessation

Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia