Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients

NCT ID: NCT06772857

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-18
• Study Completion Date: 2025-01-30

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.

Conditions

Insulin Sensitivity/Resistance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A: Aerobic Exercise + Medical and Diet Regimen

Study group A (20 patients) will receive aerobic exercise training in addition to a medical and diet regimen. Aerobic exercise training will be applied 3 times per week for 6 weeks. This exercise will include activities such as walking, cycling, or swimming to improve cardiovascular fitness and insulin sensitivity.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin is a drug used to manage blood glucose levels. It improves insulin sensitivity and reduces glucose production in the liver. This regimen will be provided to all study groups (A, B, and C) in combination with the respective interventions described for each group. Participants are instructed not to change their physical activity during the study.

Group B: Resistance Exercise + Medical and Diet Regimen

Study group B (20 patients) will receive resistance exercise training along with a medical and diet regimen. Resistance exercise training will be applied 3 times per week for 6 weeks, focusing on strength-building exercises to improve muscle mass and insulin sensitivity.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin is a drug used to manage blood glucose levels. It improves insulin sensitivity and reduces glucose production in the liver. This regimen will be provided to all study groups (A, B, and C) in combination with the respective interventions described for each group. Participants are instructed not to change their physical activity during the study.

Group C: Medical and Diet Regimen Only

Control group C (20 patients) will receive only a medical and diet regimen for 6 weeks. Patients in this group will be instructed not to change their physical activity during the study period.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Metformin is a drug used to manage blood glucose levels. It improves insulin sensitivity and reduces glucose production in the liver. This regimen will be provided to all study groups (A, B, and C) in combination with the respective interventions described for each group. Participants are instructed not to change their physical activity during the study.

Interventions

Metformin

Metformin is a drug used to manage blood glucose levels. It improves insulin sensitivity and reduces glucose production in the liver. This regimen will be provided to all study groups (A, B, and C) in combination with the respective interventions described for each group. Participants are instructed not to change their physical activity during the study.

Intervention Type: DRUG

Other Intervention Names

Glucophage; Glucophage XR; Riomet

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Police Hospital

OTHER_GOV

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

El-Sayed Essam

Lecturer at Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

El-sayed Felaya

Role: PRINCIPAL_INVESTIGATOR

Respiratory Disorder and Geriatrics Faculty of Physical Therapy Cairo University

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004665

Identifier Type: -

Identifier Source: org_study_id