Clinical trial NCT06376955: High Intensity Interval Versus Focused Ultrasound on Insulin Resistance in Diabetics With Abdominal Obesity
Official title: High Intensity Interval Exercise Versus Focused Ultrasound on Insulin Resistance in Diabetic Female Patients With Abdominal Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insulin Resistance
Abdominal Obesity
Diabetes
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body mass index
timeFrame: Before starting the study and after 4 months of treatment
measure: Waist circumference
timeFrame: Before starting the study and after 4 months of treatment
measure: Skin fold
timeFrame: Before starting the study and after 4 months of treatment
measure: Value of HbA1c and HOMA-IR hormone
timeFrame: Before starting the study and after 4 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Horus University
name: Ahmed M. Elshinnawy, Assistant
role: PRINCIPAL_INVESTIGATOR
affiliation: MTI University
name: Haitham M. Elmasry, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Misr University for Science and Technology
name: Shimaa hussien ahmed roshdy, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: