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

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ClinicalTrials.gov Identifier: NCT04643171
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Ali Mohamed Ali ismail, Cairo University

Study Description
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Brief 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 .


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: high intensity elliptical training Device: electrocaupuncture Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Markers of Oxidative Stress in Response to Electroacupuncture Against Aerobic Physical Activity in Diabetic Patients
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. superoxide dismutase [ Time Frame: It will be measured after 12 weeks ]
    marker of anti-oxidative stress


Secondary Outcome Measures :
  1. nitric oxide [ Time Frame: It will be measured after 12 weeks ]
    will be measured in plasma

  2. lipid hydroperoxidase [ Time Frame: It will be measured after 12-week training ]
    will be measured in plasma


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-representation of gender identity
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643171


Contacts
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Contact: Ali Ismail, lecturer 02 01005154209 allooka2012@gmail.com

Locations
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Egypt
Faculty of Physical Therapy Cairo University Recruiting
Giza, Dokki, Egypt
Contact: Ali Ismail, lecturer    02 01005154209    allooka2012@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ali Ismail, lecturer Cairo University
More Information
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Responsible Party: Ali Mohamed Ali ismail, lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT04643171    
Other Study ID Numbers: P.T.REC/012/002898
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases