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

May 7, 2024 updated by: Noha Ahmed Fouad Abd-Elrahman, Badr University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

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

Study Contact Backup

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

Accepts Healthy Volunteers

No

Description

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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Experimental: Group B Focused ultrasound group
Group B will receive focused ultrasound 2 times per week for 4 months in addition to intermitted fasting diet.
Other: Focused ultrasound
Focused ultrasound will be applied over the anterior abdominal, two sessions per week for 4 months, each session 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Before starting the study and after 4 months of treatment
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
Before starting the study and after 4 months of treatment
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.
Before starting the study and after 4 months of treatment
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.
Before starting the study and after 4 months of treatment

Collaborators and Investigators

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

Sponsor

Badr University

Investigators

  • Principal Investigator: Ahmed M. Elshinnawy, Assistant, Horus University
  • Principal Investigator: Haitham M. Elmasry, Lecturer, MTI University
  • Principal Investigator: Shimaa hussien ahmed roshdy, Lecturer, Misr University for Science and Technology

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)

May 8, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00014233-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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