- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06831266
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mersin, Turkey (Türkiye), 33010
- Eastern Mediterranean University
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Kyrenia
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Mersin, Kyrenia, Turkey (Türkiye), 99300
- University of Kyrenia Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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:
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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HbAc
Time Frame: 12 weeks
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It is the amount of glycosylated hemoglobin in the blood.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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HDL
Time Frame: 12 weeks
|
It is the amount of high-density lipoprotein in the blood.
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12 weeks
|
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LDL level LDL
Time Frame: 12 weeks
|
It is the amount of low-density lipoprotein in the blood.
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12 weeks
|
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CRP
Time Frame: 12 weeks
|
C-reactive protein is a protein produced in the liver.
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12 weeks
|
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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.
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12 weeks
|
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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.
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12 weeks
|
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Irisin
Time Frame: 12 weeks
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Irisin, defined as a myokine, is the proteolytic product of fibronectin type III domain 5 protein.
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12 weeks
|
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Adiponectin
Time Frame: 12 weeks
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Adiponectin is a protein hormone and adipokine, which is involved in regulating glucose levels and fatty acid breakdown.
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12 weeks
|
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IL-6
Time Frame: 12 weeks
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Interleukin-6 is an endogenous chemical involved in inflammation and B cell maturation.
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12 weeks
|
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Resistin
Time Frame: 12 weeks
|
Resistin is a hormone secreted from fat cells.
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12 weeks
|
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Kemerin
Time Frame: 12 weeks
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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.
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12 weeks
|
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Osteocalcin
Time Frame: 12 weeks
|
Osteocalcin is a bone-specific protein found in osteoblasts.
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12 weeks
|
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Leptin
Time Frame: 12 weeks
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Leptin is a hormone that acts on the hypothalamus through negative feedback secreted from fat cells, suppressing food intake and increasing energy expenditure.
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12 weeks
|
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TNF-alpha
Time Frame: 12 weeks
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Tumor necrosis factor alpha is a chemical messenger produced by the immune system that initiates inflammation.
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12 weeks
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Cardiometabolic risk level
Time Frame: 12 weeks
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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.
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12 weeks
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Body composition
Time Frame: 12 weeks
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Body composition describes the amount of fat, bone, water and muscle in the body.
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12 weeks
|
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Aerobic capacity
Time Frame: 12 weeks
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Aerobic capacity is the capacity of large striated muscle groups to adapt to work using energy obtained from aerobic metabolism.
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12 weeks
|
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Exercise Health Belief Model Scale
Time Frame: 12 weeks
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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.
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12 weeks
|
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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.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mehtap Malkoç, Eastern Mediterranean University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Behavior
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Prediabetic State
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Conditioning, Human
- Exercise
- High-Intensity Interval Training
Other Study ID Numbers
- ETK00-2023-0184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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