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

Diabete Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05845190
• Other study ID #: P.T.REC/012/003654
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: April 2023
• Source: Egyptian Chinese University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2

Intervention

Other:
• aerobic exercises
aerobic exercises in form of walking on treadmill
• resistance exercises
60% of One-repetition maximum 3 sets ( 8 to 12 ) repetitions

Locations

Country	Name	City	State
Egypt	Egyptian Chineese University	Cairo	Gesr Elsuez

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Chinese University

Country where clinical trial is conducted

Egypt, 

Outcome

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