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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high intensity elliptical training
electrocaupuncture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercised group

group of electroacupuncture

Arm Description

30 patients will receive 30 minutes of high intensity interval training on elliptical trainer, 5 times per week, for 12 week

30 patients will receive 30 minutes of electroacupuncture on bilateral PC 4 and PC 6, 5 times per week, for 12 week

Outcomes

Primary Outcome Measures

superoxide dismutase
marker of anti-oxidative stress

Secondary Outcome Measures

nitric oxide
will be measured in plasma
lipid hydroperoxidase
will be measured in plasma

Full Information

First Posted
November 19, 2020
Last Updated
November 19, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04643171
Brief Title
Oxidative Stress in Response to Electroacupuncture Against Physical Activity in Diabetic Patients
Official Title
Markers of Oxidative Stress in Response to Electroacupuncture Against Aerobic Physical Activity in Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercised group
Arm Type
Experimental
Arm Description
30 patients will receive 30 minutes of high intensity interval training on elliptical trainer, 5 times per week, for 12 week
Arm Title
group of electroacupuncture
Arm Type
Active Comparator
Arm Description
30 patients will receive 30 minutes of electroacupuncture on bilateral PC 4 and PC 6, 5 times per week, for 12 week
Intervention Type
Device
Intervention Name(s)
high intensity elliptical training
Intervention Description
30 patients will receive 30 minutes of high intensity interval training on elliptical trainer, 5 times per week, for 12 week
Intervention Type
Device
Intervention Name(s)
electrocaupuncture
Intervention Description
30 patients will receive 30 minutes of electroacupuncture on bilateral PC 4 and PC 6 for 5 times per week, for 12 week
Primary Outcome Measure Information:
Title
superoxide dismutase
Description
marker of anti-oxidative stress
Time Frame
It will be measured after 12 weeks
Secondary Outcome Measure Information:
Title
nitric oxide
Description
will be measured in plasma
Time Frame
It will be measured after 12 weeks
Title
lipid hydroperoxidase
Description
will be measured in plasma
Time Frame
It will be measured after 12-week training

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

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

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