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

Not Applicable

Not yet recruiting

• Conditions: Diabetes; Insulin Resistance; Abdominal Obesity
• Interventions: Other: Focused ultrasound; Other: High intensity interval exercise

• Registration Number: NCT06376955
• Lead Sponsor: Badr University

Brief 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.

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 Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Study Start: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B Focused ultrasound group	Focused ultrasound	Group B will receive focused ultrasound 2 times per week for 4 months in addition to intermitted fasting diet.
Group A High intrerval trainig exercise group	High intensity interval exercise	Group A will receive high intensity interval exercise 2 times per week for 4 months in addition to intermitted fasting diet.

Primary Outcome Measures

Name	Time	Method
Body mass index	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)
Value of HbA1c and HOMA-IR hormone	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.
Waist circumference	Before starting the study and after 4 months of treatment	Assessment of waist circumference of each woman by the tape measurement
Skin fold	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.