Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients

NCT06772857 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: P.T.REC/012/004665
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insulin Sensitivity/Resistance

Outcome Measures

Primary Outcomes (1)

• Change in Insulin Resistance Between Different Exercise Modes in Obese Patients

  The change in insulin resistance will be assessed using the HOMA-IR index in obese patients after different exercise interventions (aerobic vs resistance) compared to baseline. The HOMA-IR index will be calculated based on fasting blood glucose and fasting insulin levels, which are widely accepted measures of insulin resistance.

  3months

Study Arms (3)

Group A: Aerobic Exercise + Medical and Diet Regimen

EXPERIMENTAL

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.

Drug: Metformin

Group B: Resistance Exercise + Medical and Diet Regimen

EXPERIMENTAL

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.

Drug: Metformin

Group C: Medical and Diet Regimen Only

ACTIVE COMPARATOR

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.

Drug: Metformin

Interventions

Metformin 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.

Also known as: Glucophage, Glucophage XR, Riomet

Group A: Aerobic Exercise + Medical and Diet Regimen; Group B: Resistance Exercise + Medical and Diet Regimen; Group C: Medical and Diet Regimen Only

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• National Police Hospital: collaborator

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• El-sayed Felaya

  Respiratory Disorder and Geriatrics Faculty of Physical Therapy Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

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

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 14, 2025
• Study Start: July 18, 2024
• Primary Completion: August 30, 2024
• Study Completion: January 30, 2025
• Last Updated: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)