Effects of Exercise Prediabetic Individuals

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prediabetes / Type 2 Diabetes
• Intervention / Treatment: Other: High Intensity Interval Training (HIIT); Other: Moderate Intensity Continuous Training (MICT)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emine Ahsen Şenol; Phone Number: +90 533 859 31 18; Email: emineahsen.senol@kyrenia.edu.tr
• Study Contact Backup: Name: Yasin Yurt; Phone Number: +90 533 872 42 71; Email: yasin.yurt@emu.edu.tr

Study Locations

• Turkey
  • Mersin, Turkey, 33010
    • Recruiting
    • Eastern Mediterranean University
    • Contact: Yasin YURT, Asst. Prof.; Phone Number: +90 533 872 4271; Email: fzt.yasinyurt@gmail.com
    • Contact: Emine Ahsen ŞENOL, MSc; Phone Number: +90 533 859 3118; Email: senolahsen@gmail.com
  • Kyrenia
    • Mersin, Kyrenia, Turkey, 99300
      • Recruiting
      • University of Kyrenia Hospital
      • Contact: Emine Ahsen Şenol, MSc; Phone Number: +90 533 859 31 18; Email: emineahsen.senol@kyrenia.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIIT High Intensity Interval Training; High-intensity interval training (HIIT) is a type of training that involves repeated bouts of high intensity effort interspersed by recovery times.	Other: High Intensity Interval Training (HIIT); 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
Active Comparator: MICT Moderate Intensity Continuous Training; Moderate Intensity Continuous Training (MICT) consists of performing aerobic exercise at a constant and moderate intensity for a prolonged duration.	Other: Moderate Intensity Continuous Training (MICT); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbAc	It is the amount of glycosylated hemoglobin in the blood.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HDL	It is the amount of high-density lipoprotein in the blood.	12 weeks
LDL level LDL	It is the amount of low-density lipoprotein in the blood.	12 weeks
CRP	C-reactive protein is a protein produced in the liver.	12 weeks
Total cholesterol	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.	12 weeks
Triglyceride	It is a type of fat molecule found in the bloodstream and is used as the body's energy source.	12 weeks
Irisin	Irisin, defined as a myokine, is the proteolytic product of fibronectin type III domain 5 protein.	12 weeks
Adiponectin	Adiponectin is a protein hormone and adipokine, which is involved in regulating glucose levels and fatty acid breakdown.	12 weeks
IL-6	Interleukin-6 is an endogenous chemical involved in inflammation and B cell maturation.	12 weeks
Resistin	Resistin is a hormone secreted from fat cells.	12 weeks
Kemerin	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.	12 weeks
Osteocalcin	Osteocalcin is a bone-specific protein found in osteoblasts.	12 weeks
Leptin	Leptin is a hormone that acts on the hypothalamus through negative feedback secreted from fat cells, suppressing food intake and increasing energy expenditure.	12 weeks
TNF-alpha	Tumor necrosis factor alpha is a chemical messenger produced by the immune system that initiates inflammation.	12 weeks
Cardiometabolic risk level	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.	12 weeks
Body composition	Body composition describes the amount of fat, bone, water and muscle in the body.	12 weeks
Aerobic capacity	Aerobic capacity is the capacity of large striated muscle groups to adapt to work using energy obtained from aerobic metabolism.	12 weeks
Exercise Health Belief Model Scale	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.	12 weeks
Short Form-36 Questionnaire	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.	12 weeks

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Study Director: Mehtap Malkoç, Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: exercise; aerobic capacity; anti-inflammatory markers
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: ETK00-2023-0184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No