Insulin ResistancediabeticNCT06376955
High Intensity Interval Versus Focused Ultrasound on Insulin Resistance in Diabetics With Abdominal Obesity
A study testing High intensity interval exercise and Focused ultrasound in people with Insulin Resistance and Abdominal Obesity, run by Badr University.
Trial summary
Obesity and diabetes share a common insulin resistance pathway and contribute to chronic hyperglycemia. Both high-intensity interval exercise (HIIE) and focused ultrasound (FUS) have been explored in the context of managing insulin resistance in diabetic individuals with abdominal obesity, though they operate through… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Insulin Resistance, Abdominal Obesity, Diabetes
- What is being tested?
- High intensity interval exercise and Focused ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- They will be recruited from Elshinnawy physical therapy Centre.
- All are suffering from abdominal obesity
- Their age between 25-35 years old
- Their body mass index more than 30 kg/m2,
- Their waist circumference ranged from 88 cm
- The fat thickness at the treatment area was at least 2.5 cm
Who cannot join
- Females having any skin diseases in the abdomen.
- Female suffering from any physical or mental disorders.
- Females suffering from abdominal scars or hernia
- Females didn´t take any medication that might affect their weight all over the study period.
- Females complaining from any cardiovascular disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: High Intensity Interval Exercise Versus Focused Ultrasound on Insulin Resistance in Diabetic Female Patients With Abdominal Obesity
Obesity and diabetes share a common insulin resistance pathway and contribute to chronic hyperglycemia. Both high-intensity interval exercise (HIIE) and focused ultrasound (FUS) have been explored in the context of managing insulin resistance in diabetic individuals with abdominal obesity, though they operate through different mechanisms and have different implications.
Read the detailed description
Forty diabetic females aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into two equal groups, Group A will receive high intensity interval exercise 2 times per week for 4 months in addition to intermitted fasting diet. Group B will receive focused ultrasound 2 times per week for 4 months in addition to intermitted fasting diet. Assessment of abdominal obesity will be applied pre and post treatment through measuring Body mass index (BMI), Waist circumference (WC) in addition to Value of HbA1c and HOMA-IR hormone will be measured to determine effect of treatment on insulin resistance.
- Conditions
- Insulin Resistance, Abdominal Obesity, Diabetes
- Being tested
- High intensity interval exercise, Focused ultrasound
- Medical subject headings
- Insulin Resistance, Obesity, Abdominal, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval exerciseOther
HIIT is a type of interval training exercise. It incorporates several rounds that alternate between several minutes of high intensity movements followed by short periods of lower intensity movements 2 times per week for 4 months.
Focused ultrasoundOther
Focused ultrasound will be applied over the anterior abdominal, two sessions per week for 4 months, each session 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group A High intrerval trainig exercise group | Experimental | Group A will receive high intensity interval exercise 2 times per week for 4 months in addition to intermitted fasting diet. Receives: Other: High intensity interval exercise |
| Group B Focused ultrasound group | Experimental | Group B will receive focused ultrasound 2 times per week for 4 months in addition to intermitted fasting diet. Receives: Other: Focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
The weight and height of each woman in both groups will be measured to calculate the body mass index (BMI)
Measured: Before starting the study and after 4 months of treatment
Waist circumference
Assessment of waist circumference of each woman by the tape measurement
Measured: Before starting the study and after 4 months of treatment
Skin fold
The thickness of the abdominal fold will be measured using skinfold calipers to provide information on changes in subcutaneous fat in the abdominal region.
Measured: Before starting the study and after 4 months of treatment
Value of HbA1c and HOMA-IR hormone
Value of HbA1c and HOMA-IR hormone will be measured to determine effect of treatment on insulin resistance.
Measured: Before starting the study and after 4 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start8 May 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ahmed Fouad Abd-Elrahman, Badr University
- Investigators
- Ahmed M. Elshinnawy, Assistant, Principal investigator, Horus UniversityHaitham M. Elmasry, Lecturer, Principal investigator, MTI UniversityShimaa hussien ahmed roshdy, Lecturer, Principal investigator, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376955
- Sponsor's protocol ID
- IRB00014233-1
- Acronym
- diabetic
- Status last verified
- May 2024
- First submitted
- 16 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Exercise Versus Focused Ultrasound on Insulin Resistance in Diabetic Female Patients With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT06376955
- Acronym / sponsor ID
- diabetic / IRB00014233-1
- Conditions
- Insulin Resistance, Abdominal Obesity, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 8 May 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 22 Apr 2024 (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.
Obesity and diabetes share a common insulin resistance pathway and contribute to chronic hyperglycemia. Both high-intensity interval exercise (HIIE) and focused ultrasound (FUS) have been explored in the context of managing insulin resistance in diabetic individuals with abdominal obesity, though they operate through different mechanisms and have different implications.
Detailed description
Forty diabetic females aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into two equal groups, Group A will receive high intensity interval exercise 2 times per week for 4 months in addition to intermitted fasting diet. Group B will receive focused ultrasound 2 times per week for 4 months in addition to intermitted fasting diet. Assessment of abdominal obesity will be applied pre and post treatment through measuring Body mass index (BMI), Waist circumference (WC) in addition to Value of HbA1c and HOMA-IR hormone will be measured to determine effect of treatment on insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A High intrerval trainig exercise group | Experimental | Other: High intensity interval exerciseGroup A will receive high intensity interval exercise 2 times per week for 4 months in addition to intermitted fasting diet. |
| Group B Focused ultrasound group | Experimental | Other: Focused ultrasoundGroup B will receive focused ultrasound 2 times per week for 4 months in addition to intermitted fasting diet. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- They will be recruited from Elshinnawy physical therapy Centre.
- All are suffering from abdominal obesity
- Their age between 25-35 years old
- Their body mass index more than 30 kg/m2,
- Their waist circumference ranged from 88 cm
Key exclusion criteria (5 listed)
- Females having any skin diseases in the abdomen.
- Female suffering from any physical or mental disorders.
- Females suffering from abdominal scars or hernia
- Females didn´t take any medication that might affect their weight all over the study period.
- Females complaining from any cardiovascular disorders.
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 |
|---|---|---|
| High intensity interval exerciseHIIT is a type of interval training exercise. It incorporates several rounds that alternate between several minutes of high intensity movements followed by short periods of lower intensity movements 2 times per week for 4 months. | Other | Group A High intrerval trainig exercise group |
| Focused ultrasoundFocused ultrasound will be applied over the anterior abdominal, two sessions per week for 4 months, each session 40 minutes. | Other | Group B Focused ultrasound group |
Primary outcome
Body mass index
Time frame: Before starting the study and after 4 months of treatment
The weight and height of each woman in both groups will be measured to calculate the body mass index (BMI)
Waist circumference
Time frame: Before starting the study and after 4 months of treatment
Assessment of waist circumference of each woman by the tape measurement
Skin fold
Time frame: Before starting the study and after 4 months of treatment
The thickness of the abdominal fold will be measured using skinfold calipers to provide information on changes in subcutaneous fat in the abdominal region.
Value of HbA1c and HOMA-IR hormone
Time frame: Before starting the study and after 4 months of treatment
Value of HbA1c and HOMA-IR hormone will be measured to determine effect of treatment on insulin resistance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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. This study is not recruiting at the moment.
Ahmed M. Elshinnawy, Assistant principal investigator
Horus University
Haitham M. Elmasry, Lecturer principal investigator
MTI University
Shimaa hussien ahmed roshdy, Lecturer principal investigator
Misr University for Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval exercise and Focused ultrasound in people with Insulin Resistance and Abdominal Obesity, run by Badr University.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeezy Soliman Eraky, Lecturer (01003934051, zeezyeraky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: Before starting the study and after 4 months of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.