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

NCT ID: NCT04643171

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2021-03-01

Brief Summary

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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

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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

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Exercised group

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

Group Type EXPERIMENTAL

high intensity elliptical training

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

electrocaupuncture

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali Ismail, lecturer

Role: CONTACT

Phone: 02 01005154209

Email: [email protected]

Facility Contacts

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Ali Ismail, lecturer

Role: primary

Other Identifiers

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P.T.REC/012/002898

Identifier Type: -

Identifier Source: org_study_id