Effect of High Intensity Interval Training and Ultrasound Cavitation on Lipid Profile in Type 2 Diabetes Patients

NCT ID: NCT06926725

Last Updated: 2025-04-15

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-11

Study Completion Date

2026-02-01

Brief Summary

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The study aim to find out the combined effect of high intensity interval training and ultrasound cavitation on lipid profile in type two diabetic patient with abdominal obesity.

Detailed Description

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study aim to find out the combined effect of high intensity interval training and ultrasound cavitation on lipid profile in type two diabetic patient with abdominal obesity.Type two diabetic patients with abdominal obesity , randomly assigned into 3 equal groups: 66 patients

1. study group (A) 22 patients : They will receive ultrasound cavitation , HIIT and diatery advice .
2. study group (B) 22 patients : They will receive HIIT and diatery advice .
3. control group 22 patients They will only receive diatery advice.

Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Type two diabetic patients with abdominal obesity , randomly assigned into 3 equal groups: 66 patients

1. study group (A) 22 patients : They will receive ultrasound cavitation , HIIT and diatery advice .
2. study group (B) 22 patients : They will receive HIIT and diatery advice .
3. control group 22 patients They will only receive diatery advice.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

22 patients : They will receive ultrasound cavitation , HIIT and diatery advice .

Group Type EXPERIMENTAL

Cavitation : Study group A only will receive one session per week for three months (total 12 sessions ). Ultrasound treatments are performed using an applicator head with diameter 7 cm . Intensity :

Intervention Type DEVICE

Cavitation :

Study group A only will receive one session per week for three months (total 12 sessions ).

Ultrasound treatments are performed using an applicator head with diameter 7 cm .

Intensity : 0.1-0.5 w/cm2 (low) Frequency : 30-40 KHZ (low) Duration : 30 minutes

high intenisty exercise

Intervention Type OTHER

type: alternate high intensity exercise (aerobic or strength training) with recovery stages Intensity: high intensity (75%-95% HRmax) or RPE(14-16 hard to very hard ) ( according to patient tolerance), followed by active or passive recovery stage (30%-60% HRmax) or RPE(7-11 extremely light to light) .

frequency : 3 days per week for three months (with no more than 2 consecutive days between sessions) Duration: 10 seconds to 4 minutes high intensity ,12 seconds to 5 minutes active or passive recovery .(according to patient tolerance) 5 minutes warm up pre exercise . 5 minutes cool down post exercise . Progress gradually. total duration :20-40 minutes (according to patient tolerance and progression)

Diet

Intervention Type DIETARY_SUPPLEMENT

In all groups (both study groups A\&B and control group).

Group B

22 patients : They will receive HIIT and diatery advice .

Group Type EXPERIMENTAL

high intenisty exercise

Intervention Type OTHER

type: alternate high intensity exercise (aerobic or strength training) with recovery stages Intensity: high intensity (75%-95% HRmax) or RPE(14-16 hard to very hard ) ( according to patient tolerance), followed by active or passive recovery stage (30%-60% HRmax) or RPE(7-11 extremely light to light) .

frequency : 3 days per week for three months (with no more than 2 consecutive days between sessions) Duration: 10 seconds to 4 minutes high intensity ,12 seconds to 5 minutes active or passive recovery .(according to patient tolerance) 5 minutes warm up pre exercise . 5 minutes cool down post exercise . Progress gradually. total duration :20-40 minutes (according to patient tolerance and progression)

Diet

Intervention Type DIETARY_SUPPLEMENT

In all groups (both study groups A\&B and control group).

Group C

22 patients They will only receive diatery advice.

Group Type PLACEBO_COMPARATOR

Diet

Intervention Type DIETARY_SUPPLEMENT

In all groups (both study groups A\&B and control group).

Interventions

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Cavitation : Study group A only will receive one session per week for three months (total 12 sessions ). Ultrasound treatments are performed using an applicator head with diameter 7 cm . Intensity :

Cavitation :

Study group A only will receive one session per week for three months (total 12 sessions ).

Ultrasound treatments are performed using an applicator head with diameter 7 cm .

Intensity : 0.1-0.5 w/cm2 (low) Frequency : 30-40 KHZ (low) Duration : 30 minutes

Intervention Type DEVICE

high intenisty exercise

type: alternate high intensity exercise (aerobic or strength training) with recovery stages Intensity: high intensity (75%-95% HRmax) or RPE(14-16 hard to very hard ) ( according to patient tolerance), followed by active or passive recovery stage (30%-60% HRmax) or RPE(7-11 extremely light to light) .

frequency : 3 days per week for three months (with no more than 2 consecutive days between sessions) Duration: 10 seconds to 4 minutes high intensity ,12 seconds to 5 minutes active or passive recovery .(according to patient tolerance) 5 minutes warm up pre exercise . 5 minutes cool down post exercise . Progress gradually. total duration :20-40 minutes (according to patient tolerance and progression)

Intervention Type OTHER

Diet

In all groups (both study groups A\&B and control group).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* patient with type 2 diabetes.
* waist circumference \>102 cm in male ,\>88 cm in female
* lipid profile range will be (between border line and high risk ).

Exclusion Criteria

Kidney disease Heart disease Lung disease ,Liver disease ,Neurological disorders ,Pregnant women , breast feeding, immune deficiency , cancer Heavy smoker


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Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahmoud Awad Ramadan Elkholy

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Awad Ramadan Elkholy

lecturer of physical therapy

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Beni-Suif University Hospital

GIZA, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mahmoud awd elkholy, lecturer of physical therapy

Role: CONTACT

00201125746573

Facility Contacts

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Sara El-din

Role: primary

References

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Birendra Kumar Jha, Raman Mishra, Jitendra Kumar Singh, Satyam Prakash, & Kamlesh Kumar Yadav. (2024). Assessment of glycemic control and correlation of HbA1c level with lipid profile and duration of diabetes in type 2 diabetes mellitus patients. Janaki Medical College Journal of Medical Science, 12(02), 13-24. https://doi.org/10.3126/jmcjms.v12i02.68365

Reference Type BACKGROUND

Related Links

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Other Identifiers

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FPTBSUREC/0803/1241124

Identifier Type: -

Identifier Source: org_study_id

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