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

Diabetes Clinical Trial

— diabetic  

Official title:

High Intensity Interval Exercise Versus Focused Ultrasound on Insulin Resistance in Diabetic Female Patients With Abdominal Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376955
• Other study ID #: IRB00014233-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 8, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2024
• Source: Badr University
• Contact: Zeezy Soliman Eraky, Lecturer
• Phone: 01003934051
• Email: zeezyeraky[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 different mechanisms and have different implications.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Obesity
• Diabetes
• Insulin Resistance
• Obesity
• Obesity, Abdominal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index	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
Primary	Waist circumference	Assessment of waist circumference of each woman by the tape measurement	Before starting the study and after 4 months of treatment
Primary	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.	Before starting the study and after 4 months of treatment
Primary	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.	Before starting the study and after 4 months of treatment