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

NCT06376955 | Not Yet Recruiting

• 1 other identifier: IRB00014233-1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insulin Resistance; Abdominal Obesity; Diabetes

Outcome Measures

Primary Outcomes (4)

• 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

• Waist circumference

  Assessment of waist circumference of each woman by the tape measurement

  Before starting the study and after 4 months of treatment

• 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

• 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

Study Arms (2)

Group A High intrerval trainig exercise group

EXPERIMENTAL

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

Group B Focused ultrasound group

EXPERIMENTAL

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

Other: Focused ultrasound

Interventions

High intensity interval exercise 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 A High intrerval trainig exercise group

Focused ultrasound OTHER

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

Group B Focused ultrasound group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Badr University: lead

MeSH Terms

Conditions

Insulin Resistance; Obesity, Abdominal; Diabetes Mellitus

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeezy Soliman Eraky, Lecturer

CONTACT

01003934051; zeezyeraky@gmail.com

Noha Ahmed Fouad Abd El Rahman, Lecturer

CONTACT

01287499364; Noha.ahmedfouad@buc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Departments of physical therapy for women's health, Faculty of Physical Therapy, Badr University in Cairo.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 22, 2024
• Study Start: May 8, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05