NCT04643171

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 19, 2020

Last Update Submit

November 19, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • superoxide dismutase

    marker of anti-oxidative stress

    It will be measured after 12 weeks

Secondary Outcomes (2)

  • nitric oxide

    It will be measured after 12 weeks

  • lipid hydroperoxidase

    It will be measured after 12-week training

Study Arms (2)

Exercised group

EXPERIMENTAL

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

group of electroacupuncture

ACTIVE COMPARATOR

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

Device: electrocaupuncture

Interventions

high intensity elliptical trainingDEVICE

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

Exercised group
electrocaupunctureDEVICE

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

group of electroacupuncture

Eligibility Criteria

Age65 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • type 2 diabetic elderly
  • Body mass index less than 30 kg/m2.
  • Fasting blood more than 126 mg/dl

You may not qualify if:

  • cardiac patients
  • renal patients
  • respiratory patients
  • liver patients
  • patients who received any complementary therapies within 3 past months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

November 19, 2020

First Posted

November 25, 2020

Study Start

November 19, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

November 25, 2020

Record last verified: 2020-11

Locations

EG(1)