Diabetes Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 50 Years |
Eligibility | Inclusion Criteria: 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% - 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 Exclusion Criteria: 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Alaa mohamed Naguib | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | insulin sensitivity | The Homeostasis Model Assessment (HOMA):
HOMA-IR = [(Fasting Insulin (µU/mL)) X (Fasting Glucose (mmol/L))]/22.5 |
3 months | |
Secondary | assessment of glycemic control | HbA1c | 3 months | |
Secondary | blood pressure | Normal blood pressure: systolic < 140 mmHg, diastolic <90 mmHg | 3 months | |
Secondary | heart rate | Normal resting heart rate 60-90 beats per minute | 3 months | |
Secondary | respiratory rate | Normal respiratory rate for healthy adults is between 12 and 20 breaths per minute. | 3 months | |
Secondary | 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 | 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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. | 3 months | |
Secondary | smoking index | cigarette per day multiplied by years of smoking | 3 months | |
Secondary | A body shape index (ABSI) | WC divided by (BMI 2/3 multiplied by height 1/2) | 3 months |
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