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

April 11, 2025 updated by: Mahmoud Awad Ramadan Elkholy

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mahmoud awd elkholy, lecturer of physical therapy
  • Phone Number: 00201125746573
  • Email: elkholym774@gmail.com

Study Locations

  • Egypt
    • Cairo
      • Giza, Cairo, Egypt, 11865
        • Beni-Suif University Hospital
        • Contact:
          • Sara El-din

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
22 patients : They will receive ultrasound cavitation , HIIT and diatery advice .
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 :

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

Other: 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)

Dietary supplement: Diet
In all groups (both study groups A&B and control group).
Experimental: Group B
22 patients : They will receive HIIT and diatery advice .
Other: 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)

Dietary supplement: Diet
In all groups (both study groups A&B and control group).
Placebo Comparator: Group C
22 patients They will only receive diatery advice.
Dietary supplement: Diet
In all groups (both study groups A&B and control group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric Measurements
Time Frame: 3 months
It will be performed before and after the treatment . Weight in (kg) is measured by in body scale During the measurement of height in( cm) patient is barefoot . Body mass index (BMI): weight (kg)/ [ height (m)] 2
3 months
Lipid profile
Time Frame: 3 months
contains (cholesterol, triglycerides, Low-density lipoprotein cholesterol (LDL), and high-density lipoprotein cholesterol (HDL)).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahmoud Awad Ramadan Elkholy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 11, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPTBSUREC/0803/1241124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

patient privacy ,confidentially and security concern

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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