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NCT Number: NCT06772857

Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cairo University

Cairo, Egypt

About this study

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 .

  • Sixty obese prediabetic patients from both sexes with ages ranging from 30 to 40 years old.
  • Their body mass index will be ranged from 30 to 34.9 kg/m2.
  • They have insulin resistance assessed by the homeostasis model assessment for insulin resistance (HOMAIR) Levels above 1.9
  • Their blood glucose level will be ranged from 100 to 125 mg/dL (5.6-6.9 mmol/l)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Glucophage, Glucophage XR, Riomet

Primary outcomes

  1. Change in Insulin Resistance Between Different Exercise Modes in Obese Patients

    Time frame: 3months

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • National Police Hospital

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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