Oxidative Stress in Response to Electroacupuncture Against Physical Activity in Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Markers of Oxidative Stress in Response to Electroacupuncture Against Aerobic Physical Activity in Diabetic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04643171
• Other study ID #: P.T.REC/012/002898
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: allooka2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OS is an important pathogenetic mechanism for the development of T2DM and its complications.

Oxidative stress is an imbalance of the generation of free radicals or known as reactive oxygen species (ROS) and reactive nitrogen species [RNS]) and their neutralization by the antioxidant mechanisms.

Increased levels of ROS and RNS lead to damage of lipids, proteins, and DNA, ultimately causing the destruction of the islet cells of pancreas through apoptosis . Elliptical trainer device is a relatively new modality of exercise and is advertised to be superior to a treadmill because of the low joint impact and the more reasonable costs of an elliptical trainer compared to a treadmill . Additional quantative research is needed to further evaluate the effectiveness of elliptical trainers and the physiological and perceptual responses to the machine Electroacupuncture (EA) is a treatment form of traditional acupuncture in which small electrical currents are passed through needles inserted into the subject's skin using EA stimulator. It seems to have more acceptable results and effects on many important clinical applications and medical research sets .

Description:

60 diabetic patients will be randomly divided to electroacupucture group (30 patients) and high intensity elliptical training (30 patients). the treatment will be done for 5 sessions per week for 12 weeks

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• type 2 diabetic elderly

• Body mass index less than 30 kg/m2.

• Fasting blood more than 126 mg/dl

Exclusion Criteria:

• cardiac patients

• renal patients

• respiratory patients

• liver patients

• patients who received any complementary therapies within 3 past months

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• high intensity elliptical training
30 patients will receive 30 minutes of high intensity interval training on elliptical trainer, 5 times per week, for 12 week
• electrocaupuncture
30 patients will receive 30 minutes of electroacupuncture on bilateral PC 4 and PC 6 for 5 times per week, for 12 week

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy Cairo University	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	superoxide dismutase	marker of anti-oxidative stress	It will be measured after 12 weeks
Secondary	nitric oxide	will be measured in plasma	It will be measured after 12 weeks
Secondary	lipid hydroperoxidase	will be measured in plasma	It will be measured after 12-week training