High Intensity Interval Versus Focused Ultrasound on Insulin Resistance in Diabetics With Abdominal Obesity

NCT ID: NCT06376955

Last Updated: 2024-05-08

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2024-08-30

Brief Summary

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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

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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

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Insulin Resistance Abdominal Obesity Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A High intrerval trainig exercise group

Group A will receive high intensity interval exercise 2 times per week for 4 months in addition to intermitted fasting diet.

Group Type EXPERIMENTAL

High intensity interval exercise

Intervention Type OTHER

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.

Group B Focused ultrasound group

Group B will receive focused ultrasound 2 times per week for 4 months in addition to intermitted fasting diet.

Group Type EXPERIMENTAL

Focused ultrasound

Intervention Type OTHER

Focused ultrasound will be applied over the anterior abdominal, two sessions per week for 4 months, each session 40 minutes.

Interventions

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High intensity interval exercise

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.

Intervention Type OTHER

Focused ultrasound

Focused ultrasound will be applied over the anterior abdominal, two sessions per week for 4 months, each session 40 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

They will be recruited from El\_shinnawy 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

Exclusion Criteria

* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Badr University

OTHER

Sponsor Role lead

Responsible Party

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Noha Ahmed Fouad Abd-Elrahman

Departments of physical therapy for women's health, Faculty of Physical Therapy, Badr University in Cairo.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M. Elshinnawy, Assistant

Role: PRINCIPAL_INVESTIGATOR

Horus University

Haitham M. Elmasry, Lecturer

Role: PRINCIPAL_INVESTIGATOR

MTI University

Shimaa hussien ahmed roshdy, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Misr University for Science and Technology

Central Contacts

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Zeezy Soliman Eraky, Lecturer

Role: CONTACT

01003934051

Noha Ahmed Fouad Abd El Rahman, Lecturer

Role: CONTACT

01287499364

Other Identifiers

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IRB00014233-1

Identifier Type: -

Identifier Source: org_study_id

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