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The Effectiveness of Smoking Cessation in Prediabetic Smokers

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01926041
First received: August 6, 2013
Last updated: April 13, 2014
Last verified: April 2014
  Purpose

Smoking is one of major risk factor for incident type 2 diabetes mellitus (DM), and smoking cessation can improve insulin resistance. Nowadays, the second-generation cessation program in Taiwan brings higher accessibility. However, there is little evidence on the long-term health outcomes of smoking cessation for the prediabetics in the community.

This project is of five-year design. The investigators plan to recruit at least 596 prediabetic smokers and 600 prediabetic non-smokers from communities. Initially, a cross-sectional analysis will be performed to investigate the physiological and psychological characteristics in prediabetic smokers. All participants are provided with standardized diet, lifestyle education, and skills of body weight self-management, with prospective follow-up every 3-6 months. Individuals may voluntarily attend smoking cessation program. Cox regression models and Kaplan-Meier methods will be used to investigate the effectiveness of the smoking cessation and body weight self-management in prediabetics regarding new-onset DM risk, glucose control, cardiovascular events, chronic kidney diseases, chronic hepatitis or cirrhosis, malignancy, and the relevant physiological and psychological parameters of interest.


Condition Intervention
Diabetes Mellitus
Cigarette Smoking
Prediabetes
Other: Smoking cessation
Behavioral: Self-management

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Community-based Pilot Study of the Effectiveness of Smoking Cessation for Prediabetes

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Diagnosis of diabetes mellitus by ADA criteria [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    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:
  • A1C Change and Regression to Normoglycemia [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    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.

  • Diagnoses of cardiovascular events [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    by specialists

  • Chronic kidney disease progression [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    including change in eGFR and microalbuminuria

  • Chronic hepatitis or cirrhosis progression [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    confirmed by ultrasonography or advanced image or pathology studies

  • Malignancy incidence [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    confirmed by national cancer registry system


Other Outcome Measures:
  • All-cause mortality [ Time Frame: at least 3 years (from Aug 1, 2013) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: August 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smoking cessation
Participants in smoking cessation program will receive counseling from a physician and a nurse, educational materials explaining smoking cessation techniques, and prescriptions. Drugs are administered according to the manufacturer's directions, and a 1- to 4-week supply of medicine is prescribed at every clinic visit. Users can receive their medications for a course of 8 weeks in the following 90 days, with a maximum of two courses within one year (www.hpa.gov.tw). During the therapy course, physicians are allowed to adjust varenicline dosages according to tolerability.
Other: Smoking cessation
Each participant also receives counseling for individualized smoking cessation techniques at each visit. We do not prescribe the nicotine replacement therapy because it may induce insulin resistance and confound our study outcome. Bupropion is not available in our institutions and not prescribed. Varenicline users are encouraged to set either a fixed quit date or a flexible quit date. Varenicline is administered according to the manufacturer's directions, and a 1- to 4-week supply of medicine is prescribed at every clinic visit. At the end of the program, smoking status is assessed by self-reported 7-day point-prevalence abstinence, confirmed by a breath CO level of less than 3 ppm. We provide incentives to help minimize the relapse rate.
Other Names:
  • Smoking cessation program
  • Body weight control
Behavioral: Self-management
The skills of body weight self-management (with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week)are delivered through individualized counseling and educational materials. 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.
Other Names:
  • lifestyle change
  • body weight control
  • diet modifications
  • exercise
Active Comparator: Self-management
Participants who decide not to attend the smoking cessation program will be classified as self-management group. They are still provided with standardized diet and lifestyle education, with prospective follow-up of Fagerström Test for Nicotine Dependence (FTND) scores, breath carbon monoxide (CO) levels, anthropometric indices and blood tests every 3-6 months. The skills of body weight self-management (with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week) are delivered through individualized counseling and educational materials.
Behavioral: Self-management
The skills of body weight self-management (with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week)are delivered through individualized counseling and educational materials. 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.
Other Names:
  • lifestyle change
  • body weight control
  • diet modifications
  • exercise

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926041

Contacts
Contact: Chien-Hsieh Chiang, MD, MPH +886-920511256 jiansie@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Yun-Lin branch Recruiting
Yunlin, Taiwan, 640
Contact: Chien-Hsieh Chiang, MD, MPH    +886-9-20511256    jiansie@ntu.edu.tw   
Contact: Kuo-Chin Huang, MD, PhD         
Principal Investigator: Chien-Hsieh Chiang, MD, MPH         
Sub-Investigator: Kuo-Chin Huang, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Chien-Hsieh Chiang, MD, MPH National Taiwan Univeristy Hospital Yun-Lin Branch & College of Medicine
  More Information

Additional Information:
Publications:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01926041     History of Changes
Other Study ID Numbers: 201303041RINB
Study First Received: August 6, 2013
Last Updated: April 13, 2014
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on November 20, 2014