Diabetes Mellitus Type 2DiabetiesNCT06926725
Effect of High Intensity Interval Training and Ultrasound Cavitation on Lipid Profile in Type 2 Diabetes Patients
A study testing 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 :, high intenisty exercise and Diet in people with Diabetes Mellitus Type 2, run by Mahmoud Awad Ramadan Elkholy at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- 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 :, high intenisty exercise and Diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ).
Who cannot join
- Kidney disease Heart disease Lung disease ,Liver disease ,Neurological disorders ,Pregnant women , breast feeding, immune deficiency , cancer Heavy smoker
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Beni-Suif University Hospital
GIZA, Cairo Governorate, 11865
Sara El-din
About this study
Official title: 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.
Read the 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
- study group (A) 22 patients : They will receive ultrasound cavitation , HIIT and diatery advice .
- study group (B) 22 patients : They will receive HIIT and diatery advice .
- control group 22 patients They will only receive diatery advice.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- 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 :, high intenisty exercise, Diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 :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 exerciseOther
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)
DietDietary supplement
In all groups (both study groups A\&B and control group).
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | 22 patients : They will receive ultrasound cavitation , HIIT and diatery advice . Receives: 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 :; Other: high intenisty exercise; Dietary Supplement: Diet |
| Group B | Experimental | 22 patients : They will receive HIIT and diatery advice . Receives: Other: high intenisty exercise; Dietary Supplement: Diet |
| Group C | Placebo comparator | 22 patients They will only receive diatery advice. Receives: Dietary Supplement: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric Measurements
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
Measured: 3 months
Lipid profile
contains (cholesterol, triglycerides, Low-density lipoprotein cholesterol (LDL), and high-density lipoprotein cholesterol (HDL)).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start11 Apr 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Awad Ramadan Elkholy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Awad Ramadan Elkholy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926725
- Sponsor's protocol ID
- FPTBSUREC/0803/1241124
- Acronym
- Diabeties
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient privacy ,confidentially and security concern
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of High Intensity Interval Training and Ultrasound Cavitation on Lipid Profile in Type 2 Diabetes Patients With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT06926725
- Acronym / sponsor ID
- Diabeties / FPTBSUREC/0803/1241124
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Mahmoud Awad Ramadan ElkholyUniversity, hospital or other
- Study start
- 11 Apr 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- study group (A) 22 patients : They will receive ultrasound cavitation , HIIT and diatery advice .
- study group (B) 22 patients : They will receive HIIT and diatery advice .
- control group 22 patients They will only receive diatery advice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | 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 :, Other: high intenisty exercise, Dietary Supplement: Diet22 patients : They will receive ultrasound cavitation , HIIT and diatery advice . |
| Group B | Experimental | Other: high intenisty exercise, Dietary Supplement: Diet22 patients : They will receive HIIT and diatery advice . |
| Group C | Placebo comparator | Dietary Supplement: Diet22 patients They will only receive diatery advice. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 ).
Key exclusion criteria (2 listed)
- Kidney disease Heart disease Lung disease ,Liver disease ,Neurological disorders ,Pregnant women , breast feeding, immune deficiency , cancer Heavy smoker
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | group A |
| high intenisty exercisetype: 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) | Other | Group B, group A |
| DietIn all groups (both study groups A\&B and control group). | Dietary supplement | Group B, Group C, group A |
Primary outcome
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
Lipid profile
Time frame: 3 months
contains (cholesterol, triglycerides, Low-density lipoprotein cholesterol (LDL), and high-density lipoprotein cholesterol (HDL)).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Results publicationBirendra 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
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. patient privacy ,confidentially and security concern
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 :, high intenisty exercise and Diet in people with Diabetes Mellitus Type 2, run by Mahmoud Awad Ramadan Elkholy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud awd elkholy, lecturer of physical therapy (00201125746573, elkholym774@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric Measurements (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06926725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.