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Diabetes and Smoking Cessation: a Gender-Oriented Study (DiSCGO)

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ClinicalTrials.gov Identifier: NCT03426423
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Carole Clair, Policlinique Médicale Universitaire

Brief Summary:
People with diabetes still smoke at equivalent rates as non-diabetics. There is lack of evidence regarding interventions for smoking cessation among individuals with diabetes. The aim of this project is to assess the 12 months efficacy of a smoking cessation intervention tailored to diabetes and gender specificities, in a population of 500 smokers with type 2 diabetes. The secondary objectives are to assess the impact of smoking cessation on anthropometric outcomes, diabetes control and renal function and fecal microbiota.

Condition or disease Intervention/treatment Phase
Smoking Cessation Diabetes Type 2 Other: Behavioral smoking cessation intervention Other: Control Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

According to the article 18 of the LRH, participants will not be given the full information regarding the main purpose of the study (assess the efficacy of a smoking cessation trial) in order not to influence participants regarding the intervention and also to decrease selection bias (only smokers motivated to quit would take part and thus induce a selection bias). Methodologically, such a blinding to procedure would allow a better assessment of its efficacy. Furthermore, risks associated to the intervention are considered as very low. Participants will be informed a posteriori once they have completed the study or before in case they remove their consent or quit the study.

The outcome assessor will be a research collaborator independent of the study nurse who performed the intervention and blinded to the intervention.

Primary Purpose: Prevention
Official Title: Assessing the Efficacy and Impact of a Personalized Smoking Cessation Intervention Among Type 2 Diabetic Smokers in a Randomized Controlled Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
12 weeks smoking cessation intervention tailored to diabetic and gender specificities, delivered by a study nurse.
Other: Behavioral smoking cessation intervention

The intervention consists in a behavioral smoking cessation intervention combined with pharmacotherapy. The intervention is tailored it to specificities of participants based on findings from the previous phase of our study (DISCGO-MIX, Swissethics ID PB_2016-01459).

Counseling will cover topics such as assessing ambivalence and enhancing motivation with motivational interviewing methods, identifying barriers to quit, coping with cravings and intensive relapse prevention strategies. Participants will be advised to use over the counter nicotine replacement bi-therapy (NTR). A 2-week starting kit, consisting of nicotine transdermal patch and a short acting NRT (lozenge, gums, inhaler or mouth spray) will be provided to participants for free, if they wish to take NRT.

The behavioral intervention will last 30-45 minutes, and will be conducted by a research nurse using an interview guide.


Active Comparator: Control
Usual care comprising a unique intervention of 5-10 minutes, non tailored smoking cessation intervention, delivered by a study nurse.
Other: Control

Participants assigned to the control group will receive a less intensive and non-tailored intervention for smoking cessation.

For this arm the structured 3 steps AAR approach will be used:

Ask for smoking status. Advise to quit in a clear manner. Refer to external help: participants will receive a booklet with information on smoking cessation (non specific to diabetes and gender) and links to support facilities (national quitline, smoking cessation clinic, websites, self-help).

This unique intervention of 5-10 minutes will be performed by the research nurse.





Primary Outcome Measures :
  1. Continuous smoking abstinence [ Time Frame: Measured at 52 weeks ]
    continuous abstinence rate from week 12 (end of intervention) to week 52 (end of follow-up), defined as self-report of no smoking or use of other nicotine containing products (ENDS, smokeless tobacco) since the previous visit or contact, confirmed by expired monoxide level < 10 ppm.


Secondary Outcome Measures :
  1. Point prevalence smoking abstinence [ Time Frame: Change is measured at 12 week ]
    7-day point-prevalence abstinence validated by CO

  2. Point prevalence smoking abstinence [ Time Frame: Change is measured at 26 weeks ]
    7-day point-prevalence abstinence validated by CO

  3. Point prevalence smoking abstinence [ Time Frame: Change is measured at 52 weeks ]
    7-day point-prevalence abstinence validated by CO

  4. Motivation to quit smoking [ Time Frame: Change is measured from baseline to 12 week ]
    Change in motivation to quit (according to Prochaska and Di Clemente)

  5. Motivation to quit smoking [ Time Frame: Change is measured from baseline to 26 week ]
    Change in motivation to quit (according to Prochaska and Di Clemente)

  6. Motivation to quit smoking [ Time Frame: Change is measured from baseline to 52 week ]
    Change in motivation to quit (according to Prochaska and Di Clemente)

  7. Harm reduction [ Time Frame: Change is measured at 26 week ]
    Decrease in ≥ 50% of cigarette consumption

  8. Harm reduction [ Time Frame: Change is measured at 52 week ]
    Decrease in ≥ 50% of cigarette consumption

  9. Weight change [ Time Frame: Change from baseline to 26 week ]
    Change in body weight measured in kg

  10. Weight change [ Time Frame: Change from baseline to 52 week ]
    Change in body weight measured in kg

  11. Metabolic control [ Time Frame: Change is measured from baseline to 12 week ]
    Change in HbA1c

  12. Metabolic control [ Time Frame: Change is measured from baseline to 26 week ]
    Change in HbA1c

  13. Metabolic control [ Time Frame: Change is measured from baseline to 52 week ]
    Change in HbA1c

  14. Renal function [ Time Frame: Change is measured from baseline to 3 weeks. ]
    Change in renal function represented by eGFR and albumin/creatinine ratio

  15. Renal function [ Time Frame: Change is measured from baseline to 8 weeks. ]
    Change in renal function represented by eGFR and albumin/creatinine ratio

  16. Renal function [ Time Frame: Change is measured from baseline to 26 weeks. ]
    Change in renal function represented by eGFR and albumin/creatinine ratio

  17. Number of smoking quit attemps [ Time Frame: Change is measured from baseline to 12 week ]
    Number of quit attemps defined as smoking abstinence > 24h

  18. Number of smoking quit attempts [ Time Frame: Change is measured from baseline to 26 week ]
    Number of quit attempts defined as smoking abstinence > 24h

  19. Number of smoking quit attempts [ Time Frame: Change is measured from baseline to 52 week. ]
    Number of quit attempts defined as smoking abstinence > 24h

  20. Change in waist circumference [ Time Frame: Change from baseline to 26 week ]
    Change in waist circumference in cm

  21. Change in waist circumference [ Time Frame: Change from baseline to 52 week. ]
    Change in waist circumference in cm

  22. Continuous smoking abstinence [ Time Frame: At week 12 ]
    continuous abstinence rate from baseline to week 12, defined as self-report of no smoking or use of other nicotine containing products (ENDS, smokeless tobacco) since the previous visit or contact, confirmed by expired monoxide level < 10 ppm.

  23. Continuous smoking abstinence [ Time Frame: At week 26 ]
    continuous abstinence rate from week 12 to week 26, defined as self-report of no smoking or use of other nicotine containing products (ENDS, smokeless tobacco) since the previous visit or contact, confirmed by expired monoxide level < 10 ppm.


Other Outcome Measures:
  1. Exploratory microbiota outcome [ Time Frame: Change is measured from baseline to 4 weeks. ]
    Change in fecal microbiota

  2. Exploratory microbiota outcome [ Time Frame: Change is measured from baseline to 8 weeks. ]
    Change in fecal microbiota

  3. Exploratory microbiota outcome [ Time Frame: Change is measured from baseline to 26 weeks. ]
    Change in fecal microbiota



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Identification is based on self-representation of gender eligibility with the possibility to self identify as transgender.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent as documented by signature;
  • Having smoked > 100 cigarettes during his/her entire life and currently smoking cigarettes (no minimal threshold);
  • Having been diagnosed with a type 2 diabetes;
  • Being ≥ 18 years old;
  • Speaking and understanding French

Exclusion Criteria:

  • Not being able to give an informed consent and follow the procedure of the study (due to dementia, psychological disorder, language problem);
  • Being pregnant or breastfeeding;
  • Being enrolled in another smoking cessation study or program or in a multi-behavioral program including smoking cessation;
  • Enrolment of the investigator or other research collaborators, their family members, employees and other dependent persons;
  • Planning to move out of Switzerland within the next year.

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): NCT03426423


Contacts
Contact: Carole Clair, MD, MSc +41795568146 carole.clair@hospvd.ch
Contact: Aurélie Augsburger, MD +41 79 556 06 49 Aurelie.augsburger@chuv.ch

Locations
Switzerland
Policlinique Médicale Universitaire Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Carole Clair, MD, MSc    +41 79 556 81 46    carole.clair@hospvd.ch   
Contact: Priska Birrer, RN    + 41 79 556 18 23    Priska.birrer@hospvd.ch   
Sponsors and Collaborators
Carole Clair
Investigators
Principal Investigator: Carole Carole, MD, MSc Policlinique Médicale Universitaire, University of Lausanne

Responsible Party: Carole Clair, Principal Investigator, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier: NCT03426423     History of Changes
Other Study ID Numbers: 2017-00812
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carole Clair, Policlinique Médicale Universitaire:
Gender
Metabolism
Microbiota

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases