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

NCT05624970 | Unknown DMC

• 1 other identifier: P.T.REC/012/003343
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

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

  3 months

Secondary Outcomes (9)

• assessment of glycemic control

  3 months

• blood pressure

  3 months

• heart rate

  3 months

• respiratory rate

  3 months

• oxygen saturation

  3 months

Study Arms (2)

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.

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.

Behavioral: tobacco cessation and nutritional advices

Interventions

aerobic training , tobacco cessation and nutritional advices BEHAVIORAL

1. 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

group (A)

tobacco cessation and nutritional advices BEHAVIORAL

Tobacco Cessation Programs for 3 months Nutritional advices according to American Diabetes Association (ADA) 2015: for 3 months

group (B)

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Alaa mohamed Naguib

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nesreen Elnahas, professor

  Cairo Univeristy

  STUDY DIRECTOR

• Rana elbanaa, lecturer

  Cairo Univeristy

  STUDY DIRECTOR

• Yasmine mohamed, lectuere

  cairo univeristy

  STUDY DIRECTOR

Central Study Contacts

Alaa Naguib, Ass. lect.

CONTACT

01092224967; alaanaguib10@gmail.com

Nesreen Elnahas, professor

CONTACT

01002227242; Nesreen_2512@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at faculty of physical therapy

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 22, 2022
• Study Start: November 9, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

EG (1)