DiabetesNCT05624970
the Effect of Aerobic Training on Insulin Sensitivity on Diabetic Patients During Tobacco Cessation
A study testing aerobic training , tobacco cessation and nutritional advices and tobacco cessation and nutritional advices in people with Diabetes, run by Cairo University at 1 site in Egypt.
Trial summary
Prevalence of smoking in men and women ages 15 and over who currently smoke any tobacco product on a daily or non-daily basis Egypt smoking rate for 2018 was 21.40%, a 0.1% increase from 2016. Read more about this study
- Who is it for?
- Ages 40 to 50 years, men only
- Conditions the study is for
- Diabetes
- What is being tested?
- aerobic training , tobacco cessation and nutritional advices and tobacco cessation and nutritional advices
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Nov 2022to Feb 2023
- Phase
- Interventional
- 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 40 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- According to the following:
- All patients will be male.
- Their age between 40-50 years old
- Their BMI 18.5-29.9 kg/m2
- They are diagnosed as type II diabetes for more than 5 years
- Their HbA1c value from > 6.5%
Show all 10Show fewer
- Smokers for more than10-15 years
- Their smoking index will be moderate and heavy
- All patients are under full medical supervision
- All patients will quit smoking 1-7 days before undergoes aerobic training program
Who cannot join
- All patients will not have:
- Any patient is known to have any unstable medical condition.
- Any musculoskeletal or neurological disorder
- Hepatic diseases.
- Kidney disorders
- Type I diabetes mellitus
Show all 16Show fewer
- Type II insulin
- Uncontrolled hypertension
- Unstable angina pectoris
- Uncompensated heart failure
- Recent myocardial infarction
- Heart block
- Cerebrovascular disease
- Anemia
- Patients whose smoking index light
- Tobacco smokers less than 20 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Steady State Aerobic Training on Insulin Sensitivity on Diabetic Patients During Tobacco Cessation
- Prevalence of smoking in men and women ages 15 and over who currently smoke any tobacco product on a daily or non-daily basis Egypt smoking rate for 2018 was 21.40%, a 0.1% increase from 2016.
- According to WHO reports, smoking is currently responsible for six million premature deaths every year, of which 600 000 individuals die from the effects of second-hand smoke.
- Egypt is one of the 21 countries and territories of the International Diabetes Federation Middle East and North Africa (MENA) region. 463 million people have diabetes in the world and 55 million people in the MENA Region; by 2045 this will rise to 108 million.
- The most profound impact of smoking in diabetic patients is on insulin sensitivity, Cigarette smoking worsens insulin-resistance in patients with diabetes, as smoking decreases subcutaneous absorption of insulin, resulting in increased dosing requirements. When the action of insulin is impaired chronically in smokers, a dose response relationship can be seen between the number of cigarettes smoked and the degree of insulin resistance. Consequently, quitting smoking should improve glycemic control.
- Therefore diabetic patients can get huge benefits from tobacco cessation as they give their bodies chance to decrease percentage of nicotine and increase percentage of insulin so decrease risk of getting atherosclerosis, so smoking cessation improve glycemic control and insulin sensitivity.
Read the detailed description
Diabetes is a complex, chronic illness requiring continuous medical care with multifactorial risk-reduction strategies beyond glycemic control. Ongoing diabetes self-management education and support are critical to preventing acute complications and reducing the risk of long-term complications.
Nowadays, the harmful effect of smoking is no secret to anyone, unfortunately it is still causes the loss of lives for many adults and young peoples. The Ministry of Health (MOH) seeks to control it and help smokers to quit to save their lives and protect them against smoking-caused diseases such as smoking slows down lung growth in children and teens, increases a person's risk of getting tuberculosis, increases the risk of developing type2 diabetes, also most of COPD (Chronic Obstructive Pulmonary Disease) deaths are a result of smoking. The term "smoking" is not restricted to cigarette smoking only, but includes e-cigarette, shisha and others.
Although cigarette smoking is the leading avoidable cause of death, its specific effects on people with diabetes are even more intricate and profound, thus the macrovascular and microvascular complications become more quickly in smokers with diabetes, and risk of mortality increases. The increased blood pressure and altered lipid profiles in smokers with diabetes could encourage development of the insulin resistance syndrome, setting patients up for further cardiovascular problems.
One of the biggest problems for most patients undergoing a cessation program is the fear of withdrawal symptoms, including cravings, anxiety, depression, irritability, sleep disturbances, increased hunger and weight gain.
Aerobic exercise program for type 2 diabetic has showed great effects not only on glycemic control, blood lipid profiles profile, but also on reducing metabolic risk factors for cardiovascular diseases including insulin resistance. Previous studies have showed the effects of moderate-intensity exercise on the improvement of insulin sensitivity.
- Conditions
- Diabetes
- Being tested
- aerobic training , tobacco cessation and nutritional advices, tobacco cessation and nutritional advices
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic training , tobacco cessation and nutritional advicesBehavioural
- Aerobic training program according to Taheri et al 2017:
- Mode: recruits large groups of muscles and includes brisk walking on treadmill, cycling, swimming, and jogging
- Intensity: submaximal aerobic exercise program (50-60% of maximal heart rate reserve) on treadmill
- Frequency: 3 sessions a week for 2 months.
- Duration: 60 min/session The training protocol was divided into three phases: the warm up period (10 minutes), the main program (aerobic exercise; 40 minutes), and a cool down period (10 minutes).
- Tobacco Cessation Programs for 3 months
- Nutritional advices according to American Diabetes Association (ADA) 2015: for 3 months
tobacco cessation and nutritional advicesBehavioural
Tobacco Cessation Programs for 3 months Nutritional advices according to American Diabetes Association (ADA) 2015: for 3 months
| Study group | Role | What they receive |
|---|---|---|
| group (A) | Experimental | Group (A):
This group will consist of 30 patients who will receive the medical treatment (oral hypoglycemic drugs), aerobic training, tobacco cessation program and nutritional advices for 12 weeks. Receives: Behavioral: aerobic training , tobacco cessation and nutritional advices |
| group (B) | Experimental | Group (B):
This group will consist of 30 patients who will receive the medical treatment (oral hypoglycemic drugs), tobacco cessation program and nutritional advices for 12 weeks. Receives: Behavioral: tobacco cessation and nutritional advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
The Homeostasis Model Assessment (HOMA):
HOMA-IR = [(Fasting Insulin (µU/mL)) X (Fasting Glucose (mmol/L))]/22.5
Measured: 3 months
Secondary outcomes (9)
assessment of glycemic control
HbA1c
Measured: 3 months
blood pressure
Normal blood pressure: systolic < 140 mmHg, diastolic <90 mmHg
Measured: 3 months
heart rate
Normal resting heart rate 60-90 beats per minute
Measured: 3 months
respiratory rate
Normal respiratory rate for healthy adults is between 12 and 20 breaths per minute.
Measured: 3 months
oxygen saturation
A pulse oximeter can measure oxygen saturation. The generally accepted standard is that a normal resting oxygen saturation of less than 95% is considered abnormal
Measured: 3 months
ankle brachial index
The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery, it was shown that the ABI is an indicator of atherosclerosis and peripheral arterial disease(PAD) The ABI threshold most commonly used is ≤0.90.
Measured: 3 months
smoking abstintent questionnaire
The Smoking Abstinence Questionnaire, appears to capture reliably smokers' expectancies for abstinence (Withdrawal, Social Improvement/Non-smoker Identity, Adverse Outcomes, Common Reasons, Optimistic Outcomes, Coffee Use, and Weight Gain) and expectancies related to the success of a quit attempt (Treatment Effectiveness, Barriers to Treatment and Social Support). It remains to be seen how far any of these expectancies predict attempts to quit, withdrawal, treatment utilization and response and quitting success above and beyond existing measures.
Measured: 3 months
smoking index
cigarette per day multiplied by years of smoking
Measured: 3 months
A body shape index (ABSI)
WC divided by (BMI 2/3 multiplied by height 1/2)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start9 Nov 2022
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty smokers male their age ranged from 40-50 years old will be selected from diabetic outpatient clinic Qasr AL-Einy Hospital. All patients will be carefully examined by the physicians of the hospital. They will be randomly assigned into two groups equal in numbers, as group (A) and group (B). Group (A): This group will consist of 30 patients who will receive the medical treatment (oral hypoglycemic drugs), aerobic training, tobacco cessation program and nutritional advices for 12 weeks. Group (B): This group will consist of 30 patients who will receive the medical treatment (oral hypoglycemic drugs), tobacco cessation program and nutritional advices for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Naguib Ashry, Cairo University
- Investigators
- Nesreen Elnahas, professor, Study director, Cairo UniveristyRana elbanaa, lecturer, Study director, Cairo UniveristyYasmine mohamed, lectuere, Study director, cairo univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624970
- Sponsor's protocol ID
- P.T.REC/012/003343
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Steady State Aerobic Training on Insulin Sensitivity on Diabetic Patients During Tobacco Cessation
- ClinicalTrials.gov ID
- NCT05624970
- Acronym / sponsor ID
- P.T.REC/012/003343
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 22 Nov 2022 (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.
- Prevalence of smoking in men and women ages 15 and over who currently smoke any tobacco product on a daily or non-daily basis Egypt smoking rate for 2018 was 21.40%, a 0.1% increase from 2016.
- According to WHO reports, smoking is currently responsible for six million premature deaths every year, of which 600 000 individuals die from the effects of second-hand smoke.
- Egypt is one of the 21 countries and territories of the International Diabetes Federation Middle East and North Africa (MENA) region. 463 million people have diabetes in the world and 55 million people in the MENA Region; by 2045 this will rise to 108 million.
- The most profound impact of smoking in diabetic patients is on insulin sensitivity, Cigarette smoking worsens insulin-resistance in patients with diabetes, as smoking decreases subcutaneous absorption of insulin, resulting in increased dosing requirements. When the action of insulin is impaired chronically in smokers, a dose response relationship can be seen between the number of cigarettes smoked and the degree of insulin resistance. Consequently, quitting smoking should improve glycemic control.
- Therefore diabetic patients can get huge benefits from tobacco cessation as they give their bodies chance to decrease percentage of nicotine and increase percentage of insulin so decrease risk of getting atherosclerosis, so smoking cessation improve glycemic control and insulin sensitivity.
Detailed description
Diabetes is a complex, chronic illness requiring continuous medical care with multifactorial risk-reduction strategies beyond glycemic control. Ongoing diabetes self-management education and support are critical to preventing acute complications and reducing the risk of long-term complications.
Nowadays, the harmful effect of smoking is no secret to anyone, unfortunately it is still causes the loss of lives for many adults and young peoples. The Ministry of Health (MOH) seeks to control it and help smokers to quit to save their lives and protect them against smoking-caused diseases such as smoking slows down lung growth in children and teens, increases a person's risk of getting tuberculosis, increases the risk of developing type2 diabetes, also most of COPD (Chronic Obstructive Pulmonary Disease) deaths are a result of smoking. The term "smoking" is not restricted to cigarette smoking only, but includes e-cigarette, shisha and others.
Although cigarette smoking is the leading avoidable cause of death, its specific effects on people with diabetes are even more intricate and profound, thus the macrovascular and microvascular complications become more quickly in smokers with diabetes, and risk of mortality increases. The increased blood pressure and altered lipid profiles in smokers with diabetes could encourage development of the insulin resistance syndrome, setting patients up for further cardiovascular problems.
One of the biggest problems for most patients undergoing a cessation program is the fear of withdrawal symptoms, including cravings, anxiety, depression, irritability, sleep disturbances, increased hunger and weight gain.
Aerobic exercise program for type 2 diabetic has showed great effects not only on glycemic control, blood lipid profiles profile, but also on reducing metabolic risk factors for cardiovascular diseases including insulin resistance. Previous studies have showed the effects of moderate-intensity exercise on the improvement of insulin sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixty smokers male their age ranged from 40-50 years old will be selected from diabetic outpatient clinic Qasr AL-Einy Hospital. All patients will be carefully examined by the physicians of the hospital. They will be randomly assigned into two groups equal in numbers, as group (A) and group (B). Group (A): This group will consist of 30 patients who will receive the medical treatment (oral hypoglycemic drugs), aerobic training, tobacco cessation program and nutritional advices for 12 weeks. Group (B): This group will consist of 30 patients who will receive the medical treatment (oral hypoglycemic drugs), tobacco cessation program and nutritional advices for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| group (A) | Experimental | Behavioral: aerobic training , tobacco cessation and nutritional advicesGroup (A): This group will consist of 30 patients who will receive the medical treatment (oral hypoglycemic drugs), aerobic training, tobacco cessation program and nutritional advices for 12 weeks. |
| group (B) | Experimental | Behavioral: tobacco cessation and nutritional advicesGroup (B): This group will consist of 30 patients who will receive the medical treatment (oral hypoglycemic drugs), tobacco cessation program and nutritional advices for 12 weeks. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- All patients will be male.
- Their age between 40-50 years old
- Their BMI 18.5-29.9 kg/m2
- They are diagnosed as type II diabetes for more than 5 years
- Their HbA1c value from > 6.5%
Key exclusion criteria (16 listed)
- Any patient is known to have any unstable medical condition.
- Any musculoskeletal or neurological disorder
- Hepatic diseases.
- Kidney disorders
- Type I diabetes mellitus
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 |
|---|---|---|
| aerobic training , tobacco cessation and nutritional advices1. Aerobic training program according to Taheri et al 2017: * Mode: recruits large groups of muscles and includes brisk walking on treadmill, cycling, swimming, and jogging * Intensity: submaximal aerobic exercise program (50-60% of maximal heart rate reserve) on treadmill * Frequency: 3 sessions a week for 2 months. * Duration: 60 min/session The training protocol was divided into three phases: the warm up period (10 minutes), the main program (aerobic exercise; 40 minutes), and a cool down period (10 minutes). 2. Tobacco Cessation Programs for 3 months 3. Nutritional advices according to American Diabetes Association (ADA) 2015: for 3 months | Behavioural | group (A) |
| tobacco cessation and nutritional advicesTobacco Cessation Programs for 3 months Nutritional advices according to American Diabetes Association (ADA) 2015: for 3 months | Behavioural | group (B) |
Primary outcome
insulin sensitivity
Time frame: 3 months
The Homeostasis Model Assessment (HOMA): HOMA-IR = [(Fasting Insulin (µU/mL)) X (Fasting Glucose (mmol/L))]/22.5
9 secondary outcomes
assessment of glycemic control
Time frame: 3 months
blood pressure
Time frame: 3 months
heart rate
Time frame: 3 months
respiratory rate
Time frame: 3 months
oxygen saturation
Time frame: 3 months
ankle brachial index
Time frame: 3 months
smoking abstintent questionnaire
Time frame: 3 months
smoking index
Time frame: 3 months
A body shape index (ABSI)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Nesreen Elnahas, professor study director
Cairo Univeristy
Rana elbanaa, lecturer study director
Cairo Univeristy
Yasmine mohamed, lectuere study director
cairo univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic training , tobacco cessation and nutritional advices and tobacco cessation and nutritional advices in people with Diabetes, run by Cairo 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 10 inclusion and 16 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 22 Nov 2022. 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 Alaa Naguib, Ass. lect. (01092224967, alaanaguib10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin sensitivity (time frame: 3 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 22 Nov 2022.