Clinical trial NCT06772857: Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients
Official title: Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Insulin Sensitivity/Resistance
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: National Police Hospital
First posted: 2025-01-14
Enrollment: 3
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The purpose of study is to compare the effect of different exercise modes on insulin resistance and body composition in obese patients
Primary purpose: TREATMENT

Brief summary: The purpose of study is to compare the effect of different exercise modes on insulin resistance and body composition in obese patients.

Detailed description: The global epidemic of obesity becomes a major healthy, social, and economical burden.Indeed, it has been well established that obesity directly increases cardio metabolic risk by altering the insulin sensibility. Moreover, obesity causes additional health problems as it is closely associated with the development and progression of coronary heart disease.

According to the World Health Organization (WHO), Egypt ranks 18th with the highest prevalence of obesity worldwide.( Global Obesity Levels,2020) Deaths attributable to non-communicable diseases represent about 71% of the total mortality burden .(World Health Organization,2021) Lack of exercise and sedentary behaviour (prolonged sitting) are major risk factors for insulin resistance The prevalence of obesity has increased in adults in Egypt to reach about 40% according to 100million health survey (2019) compared to the 36% estimate of 2017 STEPwise survey .

This review presents established knowledge on the effects of physical activity (PA) on whole-body insulin sensitivity (SI) and body composition .

1. Sixty obese prediabetic patients from both sexes with ages ranging from 30 to 40 years old.
2. Their body mass index will be ranged from 30 to 34.9 kg/m2.
3. They have insulin resistance assessed by the homeostasis model assessment for insulin resistance (HOMAIR) Levels above 1.9
4. Their blood glucose level will be ranged from 100 to 125 mg/dL (5.6-6.9 mmol/l)
5. They will receive the same medical and diet regimen in addition to instructions not to change their physical activity during the study.

Study group A (20 patients):will receive aerobic exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.

Study group B (20 patients): will receive resistance exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.

Control group C (20 patients): will receive medical and diet regimen only for six weeks. The patients will be instructed not to change their physical activity during the study.

Eligibility criteria: Inclusion Criteria:

* Sixty obese prediabetic patients from both sexes with ages ranging from 30 to 40 years old.
* Body mass index (BMI) ranging from 30 to 34.9 kg/m².
* Insulin resistance as assessed by the homeostasis model assessment for insulin resistance (HOMA-IR) levels above 1.9.
* Blood glucose levels ranging from 100 to 125 mg/dL (5.6-6.9 mmol/L).
* Patients will receive the same medical and diet regimen, with instructions not to change their physical activity during the study.
* HbA1c levels between 6.0% and 6.5%, indicating high risk for diabetes and possible consideration for prevention interventions.

Exclusion Criteria:

* Uncontrolled diabetes.
* Uncontrolled hypertension.
* Cardiovascular disease.
* Respiratory disease.
* Hepatic disease.
* Severe life-limiting illness (e.g., cancer).
* Use of weight loss medications.
* Orthopedic or neurological disorders that limit exercise participation.
* Endocrine disorders.
* Kidney disease.

Primary outcomes:
measure: Change in Insulin Resistance Between Different Exercise Modes in Obese Patients
timeFrame: 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Respiratory Disorder and Geriatrics Faculty of Physical Therapy Cairo University
name: El-sayed Felaya
role: PRINCIPAL_INVESTIGATOR
References: