Effect of Aerobic Training Versus Resistance Training on Plasma Homocystiene in Diabetic Patients

The goal of this [clinical trial] is to [ compare ] in [ diabetic male patients ]. The main question to answer is :

Will be any difference between aerobic exercises and resistance exercises in improving levels of homocysteine, cholesterol and insulin in diabetic patients?

Participants will take their medications and group of them do aerobic exercises and another group do resistance training

Study Overview

• Status: Active, not recruiting
• Conditions: Diabete Type 2
• Intervention / Treatment: Other: aerobic exercises; Other: resistance exercises

Detailed Description

40 male diabetic patients diagnosed by type 2 diabetes mellites to evaluate therapeutics outcomes of aerobic exercises versus resistance exercises as a treatment tool on homocysteine, insulin and cholesterol levels in diabetic patients.

The patients will be randomly assigned to two equal (in number) groups:

Group (A) Twenty male patients will receive moderate intensity aerobic exercises in a form of supervised treadmill walking for 30-45 mins performed 3 times/ week for 12 weeks.

Group (B) Twenty male patients will receive resistance training program comprised 30-45 min performed 3 times /week for 12 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gesr Elsuez
    • Cairo, Gesr Elsuez, Egypt
      • Egyptian Chineese University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1- Their ages will range from 40 -55 years 2- Their body mass indexes will range between (25 to 35 Kg / m²). 3-All patients are diagnosed with type 2 diabetes mellites.
• Diagnostic criteria for type 2 diabetes were: 1) a fasting plasma glucose concentration of 7.0 mmol·L-1 or higher or 2) a plasma glucose concentration of 11.1 mmol·L-1 or higher two hours after an oral glucose challenge. (Punthakee et al.,2018).

• All subjects took oral hypoglycemic drugs but none of them were being treated with insulin when enrolled.

  4- All patients are medically and psychologically stable

Exclusion Criteria:

1. Patients with uncontrolled blood glucose level
2. Patients with unstable cardiovascular conditions (those with a known history of uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure, currently on anticoagulation therapy) were excluded from this study.
3. Patients with severe pulmonary disease (with restrictive lung disease or with obstructive lung disease).
4. Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis or severe osteoarthritis).
5. Patients with BMI > 35 will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerobic exercises group (group A ); 20 male patients with diabetes mellites Attended the program of walking on treadmill for 12 weeks according to the following parameters. Exercise prescription: Intensity: started by 60-75% of target heart rate according to each patient response. Duration: Each session consisted of five minutes warming up firstly then 25-30 minutes time of session ended by five minutes cool down exercises Frequency: Three times / week (day after day) for 12 weeks	Other: aerobic exercises; aerobic exercises in form of walking on treadmill; Other Names: group A
Experimental: resistance exercises group (group B); 20 male patients with diabetes mellites will participate in resistance training exercises 30-45 mins. The subject will warm up and cool down for at least five to seven minutes each, (before and after exercise) with initial load of 60% of 1 repetition maximum. This program consists of 3 sets of 8 to 12 repetitions, then increasing load when subject was able to complete 12 repetitions. A rest period of 1.5 min was established between each set. Mode: 4 upper body exercises (bench press, seated row, shoulder press, and pull down), 3 leg exercises (leg press, extension, and flexion), abdominal crunches and back extensions. with the individualized workloads at 60% of 1RM. Duration: 30 min-45 min (total session). Frequency: Three times / week (day after day). Intensity: increased load was established when subject was able to complete 12 repetitions.	Other: resistance exercises; 60% of One-repetition maximum 3 sets ( 8 to 12 ) repetitions; Other Names: group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
homocystiene	Homocysteine was measured with an enzyme linked immunosorbent (ELISA) method. The upper limit of normal is 15 μmol/l	12 weeks of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin	normal value <25 mlu/L fasting	12 weeks of training
cholestrol	Desirable cholesterol levels are considered to be those below 200 mg/dL in adults	12 weeks of trianing

Collaborators and Investigators

• Sponsor: Egyptian Chinese University
• Investigators: Principal Investigator: hanan hassan, Egyptian Chinese University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): May 15, 2023

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: P.T.REC/012/003654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all of the individual participant data collected during the trail, after de-identification
• IPD Sharing Time Frame: immediately following publication , no end data
• IPD Sharing Access Criteria: anyone who whishes to access the data, for any purpose

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No