Effects of Different ''Exercise Snacking'' Modalities on Glycemic Control in Patients With Type 2 Diabetes

NCT06146036 | Unknown DMC

• 1 other identifier: To snack or not to snack
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with type 2 diabetes (T2DM) face an increased risk of obesity, hypertension, and hyperglycemia, attributed to impaired cardiorespiratory fitness, elevated Hb1AC levels, and impaired lipid status. Therefore, effective prevention of complications and T2DM-related diseases is crucial for increasing the life expectancy of T2DM patients. Regular exercise plays a crucial role in the prevention and management of diabetes and its associated complications. However, most T2DM patients are not engaged in exercise. The most common causes are a lack of time, monotonous training patterns, and the severe exhaustion patients experience after recently developed and effective HIIT and SIT programs. Therefore, recent studies have explored the concept of "exercise snacking" (brief isolated bouts (\< 1 min) of intense exercise spread throughout the day ) as a promising strategy to improve glycemic control, functional capacity, and cardiometabolic health among clinical and healthy populations. However, the type, intensity, and volume of exercise bouts that result in the best improvement are unknown. Therefore, we hypothesize that these exercise modalities may also acutely improve glycaemic control in sedentary overweight patients with T2DM.

1. 1.This study will examine the acute impact of two modalities of ''Exercise Snacking'', compared with a no-exercise control (CON), on glycemic control and blood pressure
2. 2.Compare the acute effects of two ''Exercise Snacking'' modalities
3. 3.Collect data on individuals' perceptions of each workout mode using measures of Rate of Perceived Exertion (RPE), enjoyment, affect, and adverse events

Conditions

Diabetes Mellitus, Type 2; Overweight or Obesity

Keywords

exercise, high intensity, diabetes melitus

Outcome Measures

Primary Outcomes (4)

• Mean 24-hour blood glucose levels

  Blood glucose levels (mmol/L) will be measured continuously using continuous glucose monitoring system under free-living conditions without providing standardized meals

  At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).

• Time spent in hyperglycemia

  The % of the day spent above 10 mmol/L within 24 hours will be calculated using continuous glucose monitoring system under free-living conditions without providing standardized meals.

  At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).

• Glycemic variability

  Glycemic variability will be measured using the mean amplitude of glycemic excursions (MAGE) and standard deviation (SD) from mean glucose.

  At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).

• Incremental Area Under the Curve (AUC)

  The incremental area under the curve for the glucose response will be calculated using trapezoidal model.

  At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).

Secondary Outcomes (5)

• Ratings of perceived exertion (RPE)

  RPE will be examined before and after each exercise session during main experimental period.

• Adverse events

  Adverse events will be assessed through main experimental period (visit 5 , week 2; visit 6 - week 3; visit 7 - week 4)

• Exercise enjoyment

  Will be assessed immediately after each exercise session during main experimental period.

• Changes in positive and negative affect

  Changes in positive and negative affect will be measured before and after each exercise session during main experimental period.

• Blood pressure

  SBP and DBP will be measured at baseline before and after each exercise session during main experimental period.

Study Arms (3)

HIIT snacks

EXPERIMENTAL

3 x 6×1 minute cycling intervals at 90% at HRmax

Behavioral: HIIT snacks

Sprint snaks

EXPERIMENTAL

3×20-second 'all-out' cycling with 1-4 hours recovery between sprints

Behavioral: Sprint snacks

Control

EXPERIMENTAL

No exercise. Rest.

Other: Control

Interventions

HIIT snacks BEHAVIORAL

Cycling Exercise. 3 times per day 6 x 1 min at approximately 85-95% of HRmax

HIIT snacks

Sprint snacks BEHAVIORAL

Cycling Exercise. 3 times per day one ''all out'' sprint

Sprint snaks

Control OTHER

No exercise, sedentary.

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old patients who have been diagnosed with Type 2 diabetes at least 3 months prior to the start of the study according to standard criteria
• BMI between 25 and 35 kg/m2 Inactive patients according to the International Physical Activity Questionnaire
• patients receiving medical therapy (no more than two medications) and not undergoing exogenous insulin therapy
• patients free of injuries and without any contraindications to exercise or chronic diseases that might be disruptive with vigorous activity
• patients should be stable on their current diabetes medications, with no recent changes in their treatment regimen

You may not qualify if:

• patients undergoing exogenous insulin therapy or/and receiving more than two glucose-lowering medicaments
• highly physically active on the International Physical Activity Questionnaire (IPAQ)
• patients suffering from any of the ''end-stage'' chronic diseases including: renal disease, liver disease, neuropathy, cardiovascular diseases uncontrolled hypertension
• patients who are strictly prohibited by medical professionals from engaging in vigorous exercise

Sponsors & Collaborators

• University of Nis: lead

Related Publications (1)

• Lazic A, Dankovic G, Korobeinikov G, Cadenas-Sanchez C, Trajkovic N. Acute effects of different "exercise snacking'' modalities on glycemic control in patients with type 2 diabetes mellitus (T2DM): study protocol for a randomized controlled trial. BMC Public Health. 2025 Feb 11;25(1):566. doi: 10.1186/s12889-025-21669-9.

  PMID: 39934727 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Milica Pesic, PhD

  Medical Faculty, University of Nis

  STUDY DIRECTOR

Central Study Contacts

Nebojsa Trajkovic, PhD

CONTACT

+381652070462; nele_trajce@yahoo.com

Anja Lazic, MSc

CONTACT

+381600295285; anja.lazic96@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Researcher

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 24, 2023
• Study Start: January 20, 2024
• Primary Completion: February 20, 2024
• Study Completion: March 15, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12