Metabolic Syndrome in Diabetic Smokers Using Cigarettes & Combustion-Free Nicotine Delivery Systems

NCT04231838 | Recruiting DMC

• 1 other identifier: COE1-05-DIASMOKE 2.0
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

Brief Summary

Very little is known about the impact of combustion-free nicotine delivery systems (C-F NDS) on cardiovascular risk factors in T2DM patients who smoke. Data from clinical studies to identify any potential reduction in individuals' risk, relative to the risk of continued smoking, are needed. This study aims to test the hypothesis that avoiding exposure to cigarette smoke toxicants may translate to measurable improvement in cardiovascular risk factors and functional parameters when T2DM patients who smoke switch to using C-F NDS compared with T2DM patients who continue to smoke conventional tobacco products. The investigators propose a prospective 2-year multicenter randomized controlled trial (RCT) to evaluate changes in cardiovascular risk factors and functional parameters in diabetic smokers using C-F NDS and compared to those continuing cigarette smoking.

Conditions

Cardiovascular Risk Factor; Diabetes Mellitus, Type 2

Keywords

e-cigarettes; Combustion-Free Nicotine Delivery Systems; Diabetes Mellitus, Type 2; Cardiovascular Risk Factor; Tobacco Cigarettes; DIASMOKE 2.0; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Metabolic Syndrome Prevalence

  Percentage (%) change in Metabolic Syndrome Prevalence

  Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

Secondary Outcomes (5)

• Change in Plasma Glucose

  Change in plasma glucose from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

• Change in Blood Pressure

  Change in blood pressure from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

• Change in Triglycerides

  Change in triglycerides from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

• Change in High-Density Lipoprotein (HDL)

  Change in HDL from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

• Change in Waist Circumference

  Change in waist circumference from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

Study Arms (2)

Standard Arm (Arm A)

ACTIVE COMPARATOR

Participant continues smoking their own cigarette brand.

Other: TOBACCO CIGARETTES

Intervention Arm (Arm B)

ACTIVE COMPARATOR

Participant switches to using C-F NDS

Other: COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)

Interventions

TOBACCO CIGARETTES OTHER

Participants in Arm A will continue smoking their own cigarette brand as usual.

Standard Arm (Arm A)

COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS) OTHER

Participants in Arm B will trial and familiarize with their allocated products to select the C-F NDS of their preference. They will be trained and counselled on the chosen C-F NDS; participants will also have the option to try and choose among a selection of either 3 e-liquids or 3 tobacco sticks (depending on the C-F NDS they have chosen). Participants wishing to use a heated tobacco device (HTD) will receive one kit and a full 1 week supply of tobacco sticks of their choice (they will receive a number of tobacco sticks/day corresponding to the number of cigarettes smoked at baseline); those wishing to use a vaping product will receive one vaping kit and a full 1 week supply of e-liquids of their choice (they will receive 4 x 10 ml refill containers).

Intervention Arm (Arm B)

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be required to satisfy all of the following criteria at the screening visit, unless otherwise stated:
• Participants will be: 1.1. over 23 years of age
• T2DM Patients will have: 2.1. body mass index (BMI) between 17.6 and 34.5 kg/m2, inclusive 2.2. body weight exceeding 50 kg (males) or 40 kg (females) 2.3 6.0\<HbA1C\<12 3.2. completion of proforma (CRF) 3.3. lab assessment as outlined in the CRF
• Participants will be willing to refrain from eating/drinking prior to screening and Check-in at each study visit.
• Participants will be regular smokers of at least 10 cigarettes/day (max 30 cigarette/day)
• Participants will have smoked for at least five consecutive years prior to screening.
• Participants must have a saliva cotinine level \> 10 ng/mL or an exhaled breath CO (eCO) level \> 7 ppm at screening.
• Participants in Arm A who continue to smoke will be willing to use their own brand/type cigarettes.
• Participants in Arms B will be willing to use the study products (THP product or e-cigarette) provided to them during the study.

You may not qualify if:

• Participants will be excluded at the screening visit based on the following criteria:
• Female participants who are pregnant or breastfeeding. This will be confirmed at screening and at visit 1. Any female subject who becomes pregnant during this study will be withdrawn.
• Participants with a history of recent acute decompensation of their disease requiring treatment within 4 weeks prior to visit 1.
• Participants who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to screening, as determined by the investigator.
• Participants who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first product use.
• Participants who have, or who have a history of, any clinically-significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the investigator or their appropriately qualified designee, would jeopardise the safety of the subject or impact on the validity of the study results.
• Participants who regularly use any nicotine (e.g. e-cigarettes, NRT) or tobacco product (e.g. HTPs, oral smokeless) other than their own cigarettes within 14 days of screening.
• At screening and prior to enrolment, all patients will be offered a locally available free smoking cessation program as per local guidelines. Those who express the intention of booking for the cessation program together with those who, at screening, are planning to quit smoking in the next 6 months, will not be recruited in the study. Patients taking part in the study will be informed that they are free to quit smoking and withdraw from the study at any time. Any subject who decides to quit smoking will be directed to local stop smoking services.
• Withdrawal Criteria:
• Patients may be withdrawn from the study prematurely for the following reasons:
• subject experiences a severe adverse event (SAE). The appropriate SAE electronic Case Report Form (eCRF) page must be completed.
• If any deviations occur during the conduct of the study, which cannot be corrected. All protocol deviations will be fully documented and considered for their effect on study objectives. Deviations that could lead to subject discontinuation from the study include:
• deviations which could affect subject's safety (e.g. illness requiring treatment\[s\]) which in the clinical judgement of the investigator might invalidate the study by interfering with the allocated test product or the willingness of the subject to comply with the study activities.
• deviations involving the use of any nicotine/tobacco products other than the intended conventional cigarettes (in Arm A) or (in Arm B).
• If the subject is uncooperative, including non-attendance. In these cases, efforts should have been made by the investigator to ascertain the reason and to ensure the subject's attendance as soon as possible.

Sponsors & Collaborators

• Eclat Srl.: lead
• University of Catania: collaborator

Study Sites (1)

Ashford and St Peters NHS Foundation Trust

Chertsey, Surrey, KT16 0PZ, United Kingdom

RECRUITING

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• Standards of medical care in diabetes--2015: summary of revisions. Diabetes Care 38: S4, 2015 (pages 162-64)
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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Vaping; Metabolic Syndrome

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Smoking; Behavior; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Pankaj Sharma, PhD

  Ashford and St Peter's Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Saitta, PhD

CONTACT

00390954781124; daniela.saitta@eclatrbc.it

Riccardo Polosa, PhD

CONTACT

00390953781566; polosa@unict.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Arms and Randomization Plan Participants who were eligible and consent to take part will be randomized to either continuing smoking their own cigarette brand (Arm A) or switching to using C-F NDS (Arm B). The randomization sequence will be computer generated, with an allocation ratio of 1:2 (Arm A: Arm B) to compensate for an estimated 50% success rate (defined as combined smoking abstinence rate + \>80% smoking reduction rate) in the long term (more details in the section about Sample Size Calculation). The randomization scheme will be provided to clinical sites via a web-based application set up by the CRO. The staff randomizing the participant will access the web-based application when the participant is with them, entering their participant identification number, date of birth and initials into the program. The allocation will be immediately provided by the program/software.

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: January 18, 2020
• Study Start: September 27, 2021
• Primary Completion: September 16, 2025
• Study Completion: March 31, 2026
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)