the Effect of Aerobic Training on Insulin Sensitivity on Diabetic Patients During Tobacco Cessation

Diabetes Clinical Trial

Official title:

the Effect of Steady State Aerobic Training on Insulin Sensitivity on Diabetic Patients During Tobacco Cessation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05624970
• Other study ID #: P.T.REC/012/003343
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: February 2023

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: Alaa Naguib, Ass. lect.
• Phone: 01092224967
• Email: alaanaguib10[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

• 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes
• Insulin Resistance

Intervention

Behavioral:
• aerobic training , tobacco cessation and nutritional advices
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 advices
Tobacco Cessation Programs for 3 months Nutritional advices according to American Diabetes Association (ADA) 2015: for 3 months

Locations

Country	Name	City	State
Egypt	Alaa mohamed Naguib	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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