NCT06831266

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 19, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

January 29, 2025

Last Update Submit

February 19, 2025

Conditions

Prediabetes / Type 2 Diabetes

Keywords

exerciseanti-inflammatory markersaerobic capacity

Outcome Measures

Primary Outcomes (1)

  • HbAc

    It is the amount of glycosylated hemoglobin in the blood.

    12 weeks

Secondary Outcomes (18)

  • HDL

    12 weeks

  • LDL level LDL

    12 weeks

  • CRP

    12 weeks

  • Total cholesterol

    12 weeks

  • Triglyceride

    12 weeks

  • +13 more secondary outcomes

Study Arms (2)

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.

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.

Other: Moderate Intensity Continuous Training (MICT)

Interventions

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

Also known as: High Intensity Interval Training
HIIT 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)

Also known as: Moderate Intensity Continuous Training
MICT Moderate Intensity Continuous Training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kyrenia Hospital

Mersin, Kyrenia, 99300, Turkey (Türkiye)

RECRUITING

Eastern Mediterranean University

Mersin, 33010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mehtap Malkoç

    Eastern Mediterranean University

    STUDY DIRECTOR

Central Study Contacts

Emine Ahsen Şenol

CONTACT

+90 533 859 31 18emineahsen.senol@kyrenia.edu.tr

Yasin Yurt

CONTACT

+90 533 872 42 71yasin.yurt@emu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masked for biomarker evaluation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 18, 2025

Study Start

February 19, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)