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

Primary Purpose

Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aerobic training , tobacco cessation and nutritional advices
tobacco cessation and nutritional advices
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

40 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Alaa mohamed NaguibRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group (A)

group (B)

Arm Description

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.

Outcomes

Primary Outcome Measures

insulin sensitivity
The Homeostasis Model Assessment (HOMA): HOMA-IR = [(Fasting Insulin (µU/mL)) X (Fasting Glucose (mmol/L))]/22.5

Secondary Outcome Measures

assessment of glycemic control
HbA1c
blood pressure
Normal blood pressure: systolic < 140 mmHg, diastolic <90 mmHg
heart rate
Normal resting heart rate 60-90 beats per minute
respiratory rate
Normal respiratory rate for healthy adults is between 12 and 20 breaths per minute.
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
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.
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.
smoking index
cigarette per day multiplied by years of smoking
A body shape index (ABSI)
WC divided by (BMI 2/3 multiplied by height 1/2)

Full Information

First Posted
November 10, 2022
Last Updated
November 21, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05624970
Brief Title
the Effect of Aerobic Training on Insulin Sensitivity on Diabetic Patients During Tobacco Cessation
Official Title
the Effect of Steady State Aerobic Training on Insulin Sensitivity on Diabetic Patients During Tobacco Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group (A)
Arm Type
Experimental
Arm Description
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.
Arm Title
group (B)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
aerobic training , tobacco cessation and nutritional advices
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
tobacco cessation and nutritional advices
Intervention Description
Tobacco Cessation Programs for 3 months Nutritional advices according to American Diabetes Association (ADA) 2015: for 3 months
Primary Outcome Measure Information:
Title
insulin sensitivity
Description
The Homeostasis Model Assessment (HOMA): HOMA-IR = [(Fasting Insulin (µU/mL)) X (Fasting Glucose (mmol/L))]/22.5
Time Frame
3 months
Secondary Outcome Measure Information:
Title
assessment of glycemic control
Description
HbA1c
Time Frame
3 months
Title
blood pressure
Description
Normal blood pressure: systolic < 140 mmHg, diastolic <90 mmHg
Time Frame
3 months
Title
heart rate
Description
Normal resting heart rate 60-90 beats per minute
Time Frame
3 months
Title
respiratory rate
Description
Normal respiratory rate for healthy adults is between 12 and 20 breaths per minute.
Time Frame
3 months
Title
oxygen saturation
Description
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
Time Frame
3 months
Title
ankle brachial index
Description
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.
Time Frame
3 months
Title
smoking abstintent questionnaire
Description
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.
Time Frame
3 months
Title
smoking index
Description
cigarette per day multiplied by years of smoking
Time Frame
3 months
Title
A body shape index (ABSI)
Description
WC divided by (BMI 2/3 multiplied by height 1/2)
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Naguib, Ass. lect.
Phone
01092224967
Email
alaanaguib10@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nesreen Elnahas, professor
Phone
01002227242
Email
Nesreen_2512@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesreen Elnahas, professor
Organizational Affiliation
Cairo Univeristy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rana elbanaa, lecturer
Organizational Affiliation
Cairo Univeristy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yasmine mohamed, lectuere
Organizational Affiliation
cairo univeristy
Official's Role
Study Director
Facility Information:
Facility Name
Alaa mohamed Naguib
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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