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

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

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 .

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: high intensity elliptical training; Device: electrocaupuncture

Detailed 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

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

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt
      • Recruiting
      • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercised group; 30 patients will receive 30 minutes of high intensity interval training on elliptical trainer, 5 times per week, for 12 week	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
Active Comparator: group of electroacupuncture; 30 patients will receive 30 minutes of electroacupuncture on bilateral PC 4 and PC 6, 5 times per week, for 12 week	Device: electrocaupuncture; 30 patients will receive 30 minutes of electroacupuncture on bilateral PC 4 and PC 6 for 5 times per week, for 12 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
superoxide dismutase	marker of anti-oxidative stress	It will be measured after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nitric oxide	will be measured in plasma	It will be measured after 12 weeks
lipid hydroperoxidase	will be measured in plasma	It will be measured after 12-week training

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

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/012/002898

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No