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Completed

NCT Number: NCT06831266

Effects of Exercise Prediabetic Individuals

The aim of this study was to determine the effects of two different exercise protocols on body composition, aerobic capacity, blood lipid profile, some biomarkers, quality of life and exercise beliefs in participants at risk of diabetes.

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kyrenia Hospital, Mersin, Kyrenia, Turkey (Türkiye)

Loading trial locations.

About this study

After being informed about the study and possible risks, all participants who gave written informed consent and met the eligibility requirements will be randomly assigned to 2 separate groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being between 18-60 years old
  • HbA1c value between 5.7%-6.4%
  • BMI>24,9 kg/m²
  • Being sedentary
  • Not on any diet

Exclusion criteria

  • Insulin and derivative drug use
  • Uncontrolled hypertension
  • History of heart disease
  • History of MI or stroke

Treatment and study plan

High Intensity Interval Training (HIIT)

Other

1 minute interval, 1 minute active recovery

5 minutes warm-up - 3 minutes cool-down will be done at 60% of peak heart rate.

Weeks 1-2: Loading at an intensity of 85% of peak heart rate, active recovery at an intensity of 60% of peak heart rate 4x1

Weeks 2-7: Loading at an intensity of 90% of peak heart rate, active recovery at an intensity of 60% of peak heart rate 6x1

Weeks 8-12: Loading at an intensity of 90% of peak heart rate, active recovery at an intensity of 60% of peak heart rate 8x1

Other names: High Intensity Interval Training

Moderate Intensity Continuous Training (MICT)

Other

5 minutes warm-up - 3 minutes cool-down will be done at 60% of peak heart rate.

Weeks 1-2: Loading at 65% of peak heart rate intensity (22 minute)

Weeks 2-7: Loading at 75% of peak heart rate intensity (30 minute)

Weeks 8-12: Loading at 75% of peak heart rate intensity (38 minute)

Other names: Moderate Intensity Continuous Training

Primary outcomes

  1. HbAc

    Time frame: 12 weeks

    It is the amount of glycosylated hemoglobin in the blood.

Secondary outcomes

  1. HDL

    Time frame: 12 weeks

    It is the amount of high-density lipoprotein in the blood.

  2. LDL level LDL

    Time frame: 12 weeks

    It is the amount of low-density lipoprotein in the blood.

  3. CRP

    Time frame: 12 weeks

    C-reactive protein is a protein produced in the liver.

  4. Total cholesterol

    Time frame: 12 weeks

    Cholesterol is a lipid that is necessary for the construction of cell membranes in the body and the production of some hormones and vitamin D.

  5. Triglyceride

    Time frame: 12 weeks

    It is a type of fat molecule found in the bloodstream and is used as the body's energy source.

  6. Irisin

    Time frame: 12 weeks

    Irisin, defined as a myokine, is the proteolytic product of fibronectin type III domain 5 protein.

  7. Adiponectin

    Time frame: 12 weeks

    Adiponectin is a protein hormone and adipokine, which is involved in regulating glucose levels and fatty acid breakdown.

  8. IL-6

    Time frame: 12 weeks

    Interleukin-6 is an endogenous chemical involved in inflammation and B cell maturation.

  9. Resistin

    Time frame: 12 weeks

    Resistin is a hormone secreted from fat cells.

  10. Kemerin

    Time frame: 12 weeks

    It is a protein that is involved in many metabolic events such as adipogenesis, angiogenesis and glucose homeostasis, including the chemoattractant function of the belt.

  11. Osteocalcin

    Time frame: 12 weeks

    Osteocalcin is a bone-specific protein found in osteoblasts.

  12. Leptin

    Time frame: 12 weeks

    Leptin is a hormone that acts on the hypothalamus through negative feedback secreted from fat cells, suppressing food intake and increasing energy expenditure.

  13. TNF-alpha

    Time frame: 12 weeks

    Tumor necrosis factor alpha is a chemical messenger produced by the immune system that initiates inflammation.

  14. Cardiometabolic risk level

    Time frame: 12 weeks

    Cardiometabolic risk has been defined as a cluster of metabolic and cardiovascular abnormalities, including abdominal obesity, insulin resistance, hypertension, dyslipidemia, and atherosclerosis, that predispose individuals to cardiovascular disease and type 2 diabetes.

  15. Body composition

    Time frame: 12 weeks

    Body composition describes the amount of fat, bone, water and muscle in the body.

  16. Aerobic capacity

    Time frame: 12 weeks

    Aerobic capacity is the capacity of large striated muscle groups to adapt to work using energy obtained from aerobic metabolism.

  17. Exercise Health Belief Model Scale

    Time frame: 12 weeks

    Exercise Health Belief Model Scale is a 5-point Likert-type scale consists of 32 items.The scale consists of 5 factors and there is no reverse item. The highest and lowest score on the scale is 160 and 32, respectively. Higher scores indicate higher level of exercise health belief.

  18. Short Form-36 Questionnaire

    Time frame: 12 weeks

    The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. High scores indicate good health status.

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study title

Comparison of the Effects of High-Intensity Interval Exercise Training and Moderate-Intensity Continuous Exercise Training in Prediabetic Individuals: Single-Blind Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Jun 23, 2026

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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