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Typ 2 DiabetesNCT07876180

Effects of High-Intensity Interval Training and Exercise Snacking on Glycemic Control and Cardiorespiratory Fitness in Adults With Type 2 Diabetes Mellitus

A study testing Exercise in people with Typ 2 Diabetes, run by University of Nis at 1 site in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial investigates whether two time-efficient forms of high-intensity exercise, high-intensity interval training (HIIT) and exercise snacking, improve glycemic control, cardiorespiratory fitness and other cardiometabolic risk factors in adults with type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Typ 2 Diabetes
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSerbia
Study dates
20 Jan 2026to 27 Aug 2026
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-65 years
  • Diagnosis of type 2 diabetes mellitus for at least 6 months, based on standard criteria (fasting plasma glucose ≥7.0 mmol/L [≥126 mg/dL] and/or HbA1c ≥6.5% [≥48 mmol/mol])
  • Physically inactive according to the International Physical Activity Questionnaire (IPAQ): <150 min/week of moderate-intensity or <75 min/week of vigorous-intensity physical activity, or <600 MET-min/week
  • Treated with oral glucose-lowering medication, or with insulin for at least 3 months before enrollment
  • Stable pharmacological treatment with no recent changes in the therapeutic regimen
  • No musculoskeletal injuries or contraindications to high-intensity exercise
  • No chronic conditions that are inadequately controlled by standard medical therapy or that could be aggravated by high-intensity exercise
  • No episodes of severe hyperglycemia or hypoglycemia requiring hospitalization within the previous 3 months

Who cannot join

  • Physically active according to IPAQ criteria (vigorous-intensity activity on ≥3 days/week achieving at least 600-1500 MET-min/week, or ≥5 days/week of any combination of walking, moderate- or vigorous-intensity activity achieving at least 600-3000 MET-min/week)
  • Diagnosed nephropathy, liver disease or neuropathy
  • Cardiovascular disease, including absolute contraindications to exercise such as unstable angina, recent myocardial infarction or uncontrolled symptomatic heart failure
  • Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg)
  • History of respiratory disease, including pulmonary hypertension or chronic obstructive pulmonary disease
  • Moderate to severe somatic or autonomic neuropathy, retinopathy, or other musculoskeletal or neurological impairments that contraindicate high-intensity exercise
  • Electrocardiographic abnormalities judged clinically significant by a specialist physician
  • Acute illness with recovery lasting longer than 3 weeks, or recovery from acute illness completed within the 3 weeks preceding the intervention Medical advice to avoid high-intensity or any physical activity due to potential worsening of an existing condition

Trial locations and contacts

1 site in 1 country.

Serbia1 site
  • Faculty of Sport and Physical Education, University of Niš

    Niš, Serbia, 18106

Other trials in Serbia

About this study

Official title: Effects of High-Intensity Interval Training and Exercise Snacking on Glycemic Control and Cardiorespiratory Fitness in Adults With Type 2 Diabetes Mellitus: a Randomized Controlled Trial

This randomized controlled trial investigates whether two time-efficient forms of high-intensity exercise, high-intensity interval training (HIIT) and exercise snacking, improve glycemic control, cardiorespiratory fitness and other cardiometabolic risk factors in adults with type 2 diabetes mellitus. Over 12 weeks, participants were allocated to HIIT, exercise snacking, or a non-exercise control group. The study addresses two questions: whether each exercise modality improves these outcomes relative to no exercise, and whether accumulating vigorous exercise in brief bouts throughout the day produces adaptations comparable to those of conventional interval training performed in a single session.

Read the detailed description

Regular exercise is a cornerstone of type 2 diabetes mellitus (T2DM) management, yet most individuals with T2DM do not meet recommended physical activity levels, with lack of time among the most frequently reported barriers. High-intensity interval training (HIIT) improves glycemic control and cardiorespiratory fitness with a lower time commitment than moderate-intensity continuous exercise (MICT). Exercise snacking, in which brief bouts of vigorous exercise are distributed across the day, has been shown to attenuate postprandial glucose responses acutely. Whether exercise snacking produces chronic adaptations comparable to those of conventional HIIT has not been established.

This was a three-arm, parallel-group randomized controlled trial. Participants were recruited in collaboration with endocrinologists, the Primary Health Care Centre Leskovac, and local diabetes associations. Fifty-one participants were allocated by block randomization (1:1:1 allocation ratio) to exercise snacking group (n = 17), HIIT group (n = 17), or a control group (CON, n = 17). Sample size was calculated a priori for HbA1c (G*Power 3.1; repeated-measures ANOVA, within-between interaction, f = 0.25, α = 0.05, power = 0.80). This required 42 participants, which was increased to 51 to allow for an anticipated 20% dropout.

Both exercise groups trained on cycle ergometers under supervision, two days per week for 12 weeks. Training intensity was prescribed from age-predicted maximal heart rate (HRmax = 208 - 0.7 × age) and monitored continuously with heart rate monitors. Perceived exertion was recorded on the 0-10 RPE scale. The exercise snacking protocol, adapted from Francois et al. (2014), was performed three times per training day, before each main meal. Each session comprised a 5-minute self-paced warm-up, six 1-minute intervals at 90-95% HRmax separated by 1-minute passive or active recovery, and a 3-minute cool-down. The HIIT protocol was performed once per training day in the afternoon or early evening. Each 35-minute session comprised a 5-minute warm-up, four 4-minute intervals at 90% HRmax separated by 3-minute active recovery at 70% HRmax, and a 2-minute cool-down. Workload was progressively adjusted to keep heart rate within the target range. The CON was advised to maintain habitual physical activity and dietary habits. Diet was not controlled in any group, and participants were instructed not to change their usual eating habits. To minimize the risk of hypoglycemia, capillary glucose was measured before and after every session according to established safety recommendations for exercise in diabetes.

All assessments were performed at baseline and after the 12-week intervention in a standardized order. Fasting venous blood samples were collected between 07:00 and 10:00 h after an 8-12 h fast. Fasting glucose was analysed on a Beckman Coulter DxC 700 AU analyser and HbA1c on a HumaNex A1C analyser. Postprandial capillary glucose was self-measured by participants with an Accu-Chek glucometer 180 minutes after breakfast, lunch and dinner. Body composition was assessed by bioelectrical impedance (Omron BF-511), and blood pressure with an automated oscillometric device (Omron HEM-7130). The 6-minute walk test was performed according to American Thoracic Society guidelines on a 30-m outdoor course. Peak oxygen uptake was estimated from walk distance using the Ross et al. (2010) equation and also expressed in absolute terms using body mass. Health-related quality of life was assessed with the WHOQOL-BREF questionnaire.

Intervention effects were analysed using a 3 × 2 mixed-design ANOVA, with the time × group interaction as the main test of intervention-specific effects. Changes from baseline were compared between groups with 95% confidence intervals and Bonferroni-adjusted post-hoc comparisons. Inter-individual variability in response was evaluated using predefined thresholds for clinically meaningful change and the standard deviation of individual responses, with the CON used to account for random variation.

Conditions
Typ 2 Diabetes
Being tested
Exercise
Keywords
High-Intensity Interval Training, hyperglicemia, exercise snacking, cardiometabolic health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Exercise Snacking - interval cycling performed as three short sessions per training day, each completed before a main meal (breakfast, lunch and dinner). Each session comprised six 1-minute intervals at 90-95% of age-predicted maximal heart rate with 1-minute recovery, preceded by a 5-minute warm-up and followed by a 3-minute cool-down (approximately 20 minutes per session). Performed under supervision on a cycle ergometer, two days per week for 12 weeks.

    HIIT - interval cycling performed as a single 35-minute session per training day in the afternoon or early evening. Each session comprised four 4-minute intervals at 90% of age-predicted maximal heart rate with 3-minute active recovery at 70% of maximal heart rate, preceded by a 5-minute warm-up and followed by a 2-minute cool-down. Performed under supervision on a cycle ergometer, two days per week for 12 weeks

Study groups in NCT07876180
Study groupRoleWhat they receive
Exercise SnackingExperimentalParticipants performed exercise snacking on a cycle ergometer under supervision, two days per week for 12 weeks. On each training day, three short sessions were performed, one before each main meal (breakfast, lunch and dinner). Each session consisted of a 5-minute self-paced warm-up, six 1-minute intervals at 90-95% of age-predicted maximal heart rate separated by 1 minute of passive or active recovery at minimal resistance, and a 3-minute cool-down (approximately 20 minutes per session). Workload was progressively adjusted to maintain the target heart rate, which was monitored continuously with heart rate monitors. Perceived exertion was recorded using the 0-10 RPE scale.
Receives: Behavioral: Exercise
HIITExperimentalParticipants performed HIIT on a cycle ergometer under supervision, two days per week for 12 weeks. On each training day, one session was performed in the afternoon or early evening. Each 35-minute session consisted of a 5-minute warm-up (4 minutes at 60% and 1 minute at 70% of age-predicted maximal heart rate), four 4-minute intervals at 90% of maximal heart rate separated by 3 minutes of active recovery at 70% of maximal heart rate, and a 2-minute cool-down at 70% of maximal heart rate. Workload was progressively adjusted to maintain the target heart rate, which was monitored continuously with heart rate monitors. Perceived exertion was recorded using the 0-10 RPE scale.
Receives: Behavioral: Exercise
ControlNo interventionParticipants did not take part in any structured exercise program during the 12-week study period. They were advised to maintain their habitual physical activity, dietary habits and usual medical care, and completed the same baseline and post-intervention assessments as the exercise groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycated hemoglobin (HbA1c)

    HbA1c (%) measured in venous whole blood (EDTA) using the HumaNex A1C analyzer, sampled between 07:00 and 10:00 h after an 8-12 h overnight fast.

    Measured: From enrollment to the end of treatment at 12 weeks.

  2. Change in fasting blood glucose (FBG)

    Fasting serum glucose (mmol/L) measured in venous blood after an 8-12 h overnight fast using an automated biochemical analyzer (Beckman Coulter DxC 700 AU).

    Measured: From enrollment to the end of treatment at 12 weeks.

  3. Change in estimated relative peak oxygen uptake (VO₂peak)

    Relative VO₂peak (mL·kg-¹·min-¹) estimated from 6-minute walk distance using the Ross et al. (2010) equation: VO₂peak = 0.025 × distance (m) + 4.682.

    Measured: From enrollment to the end of treatment at 12 weeks.

  4. Change in estimated absolute peak oxygen uptake (VO₂peak)

    Absolute VO₂peak (L·min-¹) calculated from estimated relative VO₂peak and body mass.

    Measured: From enrollment to the end of treatment at 12 weeks.

Secondary outcomes (11)
  1. Change in 6-minute walk distance (6MWT)

    Distance (m) covered during the 6 MWT, performed according to American Thoracic Society guidelines on a 30-m outdoor course.

    Measured: From enrollment to the end of treatment at 12 weeks.

  2. Change in postprandial glucose after breakfast

    Capillary blood glucose (mmol/L) self-measured with an Accu-Chek glucometer 180 minutes after breakfast.

    Measured: From enrollment to the end of treatment at 12 weeks.

  3. Change in postprandial glucose after lunch

    Capillary blood glucose (mmol/L) self-measured with an Accu-Chek glucometer 180 minutes after lunch.

    Measured: From enrollment to the end of treatment at 12 weeks.

  4. Change in postprandial glucose after dinner

    Capillary blood glucose (mmol/L) self-measured with an Accu-Chek glucometer 180 minutes after dinner.

    Measured: From enrollment to the end of treatment at 12 weeks.

  5. Change in body mass

    Body mass (kg) measured by bioelectrical impedance analysis (Omron BF-511).

    Measured: From enrollment to the end of treatment at 12 weeks.

  6. Change in body mass index

    Body mass index measured by bioelectrical impedance analysis (Omron BF-511).

    Measured: From enrollment to the end of treatment at 12 weeks.

  7. Change in body fat percentage

    Body fat (%) estimated by bioelectrical impedance analysis (Omron BF-511).

    Measured: From enrollment to the end of treatment at 12 weeks.

  8. Change in muscle mass percentage

    Skeletal muscle mass (%) estimated by bioelectrical impedance analysis (Omron BF-511).

    Measured: From enrollment to the end of treatment at 12 weeks.

  9. Change in systolic blood pressure

    Resting systolic blood pressure (mmHg) measured in a seated position with an automated device (Omron HEM-7130); two measurements separated by 3 minutes.

    Measured: From enrollment to the end of treatment at 12 weeks.

  10. Change in diastolic blood pressure

    Resting diastolic blood pressure (mmHg) measured in a seated position with an automated device (Omron HEM-7130); two measurements separated by 3 minutes.

    Measured: From enrollment to the end of treatment at 12 weeks.

  11. Change in health-related quality of life

    WHOQOL-BREF scores for the physical health, psychological, social relationships and environment domains (0-100; higher scores indicate better quality of life), together with overall quality of life (Q1) and satisfaction with health (Q2).

    Measured: From enrollment to the end of treatment at 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start20 Jan 2026
  3. Primary completion17 Jul 2026
  4. Study completion27 Aug 2026

Resources

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
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876180
Sponsor's protocol ID
04-2363/2
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Typ 2 Diabetes, run by University of Nis at 1 site in Serbia.

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 8 inclusion and 8 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Serbia. 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?

Change in glycated hemoglobin (HbA1c) (time frame: From enrollment to the end of treatment at 12 weeks.). The study lists 4 primary outcomes in all. 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 15 Oct 2026.

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