Prediabetes / Type 2 DiabetesNCT06831266
Effects of Exercise Prediabetic Individuals
A study testing High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MICT) in people with Prediabetes / Type 2 Diabetes, run by Eastern Mediterranean University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prediabetes / Type 2 Diabetes
- What is being tested?
- High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MICT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 19 Feb 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between 18-60 years old
- HbA1c value between 5.7%-6.4%
- BMI>24,9 kg/m²
- Being sedentary
- Not on any diet
Who cannot join
- Insulin and derivative drug use
- Uncontrolled hypertension
- History of heart disease
- History of MI or stroke
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
University of Kyrenia Hospital
Mersin, Kyrenia, 99300
Eastern Mediterranean University
Mersin, 33010
About this study
Official 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
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.
Read the 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.
- Conditions
- Prediabetes / Type 2 Diabetes
- Being tested
- High Intensity Interval Training (HIIT), Moderate Intensity Continuous Training (MICT)
- Keywords
- exercise, anti-inflammatory markers, aerobic capacity
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training (HIIT)Other
Also called High Intensity Interval Training
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
Moderate Intensity Continuous Training (MICT)Other
Also called Moderate Intensity Continuous Training
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)
| Study group | Role | What they receive |
|---|---|---|
| HIIT High Intensity Interval Training | Experimental | High-intensity interval training (HIIT) is a type of training that involves repeated bouts of high intensity effort interspersed by recovery times. Receives: Other: High Intensity Interval Training (HIIT) |
| MICT Moderate Intensity Continuous Training | Active comparator | Moderate Intensity Continuous Training (MICT) consists of performing aerobic exercise at a constant and moderate intensity for a prolonged duration. Receives: Other: Moderate Intensity Continuous Training (MICT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbAc
It is the amount of glycosylated hemoglobin in the blood.
Measured: 12 weeks
Secondary outcomes (18)
HDL
It is the amount of high-density lipoprotein in the blood.
Measured: 12 weeks
LDL level LDL
It is the amount of low-density lipoprotein in the blood.
Measured: 12 weeks
CRP
C-reactive protein is a protein produced in the liver.
Measured: 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.
Measured: 12 weeks
Triglyceride
It is a type of fat molecule found in the bloodstream and is used as the body's energy source.
Measured: 12 weeks
Irisin
Irisin, defined as a myokine, is the proteolytic product of fibronectin type III domain 5 protein.
Measured: 12 weeks
Adiponectin
Adiponectin is a protein hormone and adipokine, which is involved in regulating glucose levels and fatty acid breakdown.
Measured: 12 weeks
IL-6
Interleukin-6 is an endogenous chemical involved in inflammation and B cell maturation.
Measured: 12 weeks
Resistin
Resistin is a hormone secreted from fat cells.
Measured: 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.
Measured: 12 weeks
Osteocalcin
Osteocalcin is a bone-specific protein found in osteoblasts.
Measured: 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.
Measured: 12 weeks
TNF-alpha
Tumor necrosis factor alpha is a chemical messenger produced by the immune system that initiates inflammation.
Measured: 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.
Measured: 12 weeks
Body composition
Body composition describes the amount of fat, bone, water and muscle in the body.
Measured: 12 weeks
Aerobic capacity
Aerobic capacity is the capacity of large striated muscle groups to adapt to work using energy obtained from aerobic metabolism.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start19 Feb 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetes / Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahsen Şenol, University of Kyrenia
- Investigators
- Mehtap Malkoç, Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831266
- Sponsor's protocol ID
- ETK00-2023-0184
- Status last verified
- Jun 2026
- First submitted
- 29 Jan 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06831266
- Acronym / sponsor ID
- ETK00-2023-0184
- Conditions
- Prediabetes / Type 2 Diabetes
- Keywords
- exercise, anti-inflammatory markers, aerobic capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| HIIT High Intensity Interval Training | Experimental | Other: High Intensity Interval Training (HIIT)High-intensity interval training (HIIT) is a type of training that involves repeated bouts of high intensity effort interspersed by recovery times. |
| MICT Moderate Intensity Continuous Training | Active comparator | Other: Moderate Intensity Continuous Training (MICT)Moderate Intensity Continuous Training (MICT) consists of performing aerobic exercise at a constant and moderate intensity for a prolonged duration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between 18-60 years old
- HbA1c value between 5.7%-6.4%
- BMI>24,9 kg/m²
- Being sedentary
- Not on any diet
Key exclusion criteria (4 listed)
- Insulin and derivative drug use
- Uncontrolled hypertension
- History of heart disease
- History of MI or stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training (HIIT)Also: High Intensity Interval Training1 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 | HIIT High Intensity Interval Training |
| Moderate Intensity Continuous Training (MICT)Also: Moderate Intensity Continuous Training5 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 | MICT Moderate Intensity Continuous Training |
Primary outcome
HbAc
Time frame: 12 weeks
It is the amount of glycosylated hemoglobin in the blood.
18 secondary outcomes
HDL
Time frame: 12 weeks
LDL level LDL
Time frame: 12 weeks
CRP
Time frame: 12 weeks
Total cholesterol
Time frame: 12 weeks
Triglyceride
Time frame: 12 weeks
Irisin
Time frame: 12 weeks
Adiponectin
Time frame: 12 weeks
IL-6
Time frame: 12 weeks
Resistin
Time frame: 12 weeks
Kemerin
Time frame: 12 weeks
Osteocalcin
Time frame: 12 weeks
Leptin
Time frame: 12 weeks
TNF-alpha
Time frame: 12 weeks
Cardiometabolic risk level
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Aerobic capacity
Time frame: 12 weeks
Exercise Health Belief Model Scale
Time frame: 12 weeks
Short Form-36 Questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehtap Malkoç study director
Eastern Mediterranean University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MICT) in people with Prediabetes / Type 2 Diabetes, run by Eastern Mediterranean University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbAc (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.