Smoking CessationNCT06687213
Effect of Smoking Cessation on Glycemic Control in Type 2 Diabetics
An observational study of Smoking Cessation, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the long-term effects of smoking cessation on glycemic control in type 2 diabetic patients The main question it aims to answer is: Does smoking cessation lower HbA1c in type 2 diabetics on long term ? The participants will be counseled to cessate smoking and will… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking cessation counselling group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 178 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Moderate Somking index Having been diagnosed with a type 2 diabetes Being ≥ 35 years old HbA1c > 7
Who cannot join
- Type 1 diabetes Drug induced Diabetes mellitus Type 2 diabetes on insulin treatment
Trial locations and contacts
1 site in 1 country.
Alhasnaa M Rawy, Bachelor of medicine & surgery contact
Egypt1 site
Assuit university
Asyut
Assuit university, +2088 22080150, vp_grad@aun.edu.eg
About this study
Official title: Effect of Smoking Cessation on Glycemic Control in Patients with Type 2 Diabetes
The goal of this observational study is to learn about the long-term effects of smoking cessation on glycemic control in type 2 diabetic patients The main question it aims to answer is:
Does smoking cessation lower HbA1c in type 2 diabetics on long term ? The participants will be counseled to cessate smoking and will be followed for 6 months and compared to control who will not cessate smoking .
Read the detailed description
Smoking and diabetes are both major public health issues specially in our community. They act synergistically on morbidity and mortality. Diabetic smokers have much higher rates of micro and macrovascular complications. [Carole Clair et al., 2020] Approximately 1.3 billion people worldwide use tobacco, most commonly in the form of tobacco smoking, and more than 7 million people die every year as a result of smoking related conditions [Magdalena Walicka et al.,2022] Exposure to cigarette smoke is associated with vascular damage, endothelial dysfunction, and activation of oxidative stress, inflammatory pathways, coagulation, and fibrinolysis A similar mechanism of endothelial dysfunction is described for people with diabetes. It is therefore not surprising that smoking enhances the combined harmful effects of elevated blood glucose levels, accelerating vascular damage in diabetic patients who smoke The prevalence of current smoking was 45.5% in male patients with type 2 diabetes. The levels of fasting blood glucose and HbA1c increased with number of cigarettes smoked per day compared with non-smokers Smoking and its cessation showed dose- and time-dependent relationship with glycemic control and insulin resistance in patients with type 2 diabetes mellitus. These findings may highlight the importance of smoking cessation in the clinical management of diabetes mellitus.
the effect of smoking and its cessation on glycemic control in diabetic patients has not been fully examined yet.
There is lack of evidence regarding interventions for smoking cessation among individuals with diabetes
- Conditions
- Smoking Cessation
- Being tested
- Smoking cessation counselling group
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation counselling groupBehavioural
Case group will be counseled to cessate smoking and will be followed up with HbA1c
| Study group | Role | What they receive |
|---|---|---|
| 1_Case group 2_control group | 1. Case group diabetic smokers which will be counseled to cessate smoking
2. Control group diabetic smokers which will refuse to cessate smoking Receives: Behavioral: Smoking cessation counselling group | |
| Case control group | Case group: diabetic smokers which will cessate smoking Control group: diabetic smokers which will refuse to cessate smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control after smoking cessation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alhasnaa Mohamed Abdo Rawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687213
- Sponsor's protocol ID
- Smoking cessation and HbA1C
- Status last verified
- Oct 2024
- First submitted
- 12 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking Cessation on Glycemic Control in Patients with Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06687213
- Acronym / sponsor ID
- Smoking cessation and HbA1C
- Conditions
- Smoking Cessation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the long-term effects of smoking cessation on glycemic control in type 2 diabetic patients The main question it aims to answer is:
Does smoking cessation lower HbA1c in type 2 diabetics on long term ? The participants will be counseled to cessate smoking and will be followed for 6 months and compared to control who will not cessate smoking .
Detailed description
Smoking and diabetes are both major public health issues specially in our community. They act synergistically on morbidity and mortality. Diabetic smokers have much higher rates of micro and macrovascular complications. [Carole Clair et al., 2020] Approximately 1.3 billion people worldwide use tobacco, most commonly in the form of tobacco smoking, and more than 7 million people die every year as a result of smoking related conditions [Magdalena Walicka et al.,2022] Exposure to cigarette smoke is associated with vascular damage, endothelial dysfunction, and activation of oxidative stress, inflammatory pathways, coagulation, and fibrinolysis A similar mechanism of endothelial dysfunction is described for people with diabetes. It is therefore not surprising that smoking enhances the combined harmful effects of elevated blood glucose levels, accelerating vascular damage in diabetic patients who smoke The prevalence of current smoking was 45.5% in male patients with type 2 diabetes. The levels of fasting blood glucose and HbA1c increased with number of cigarettes smoked per day compared with non-smokers Smoking and its cessation showed dose- and time-dependent relationship with glycemic control and insulin resistance in patients with type 2 diabetes mellitus. These findings may highlight the importance of smoking cessation in the clinical management of diabetes mellitus.
the effect of smoking and its cessation on glycemic control in diabetic patients has not been fully examined yet.
There is lack of evidence regarding interventions for smoking cessation among individuals with diabetes
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1_Case group 2_control group | – | Behavioral: Smoking cessation counselling group1. Case group diabetic smokers which will be counseled to cessate smoking 2. Control group diabetic smokers which will refuse to cessate smoking |
| Case control group | – | –Case group: diabetic smokers which will cessate smoking Control group: diabetic smokers which will refuse to cessate smoking |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- Moderate Somking index Having been diagnosed with a type 2 diabetes Being ≥ 35 years old HbA1c > 7
Key exclusion criteria (1 listed)
- Type 1 diabetes Drug induced Diabetes mellitus Type 2 diabetes on insulin treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation counselling groupCase group will be counseled to cessate smoking and will be followed up with HbA1c | Behavioural | 1_Case group 2_control group |
Primary outcome
Glycemic control after smoking cessation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alhasnaa M Rawy, Bachelor of medicine & surgery contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alhasnaa M Rawy, Bachelor of medicine & surgery (+2001023801711, alhsnaa.16266104@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control after smoking cessation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.