Comparing Moderate and High-intensity Interval Training Protocols on Biomarkers in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To overcome the lack of knowledge regarding the relative role of different intensities of
      aerobic training in adults with type 2 (T2D) diabetes, a 12 month randomized controlled trial
      will be performed to assess and compare the impact of two exercise groups: 1- high intensity
      interval training (HIIT) with resistance training; 2- moderate continuous training (MCT) with
      resistance training; and 3- a standard counseling home based control group; on hemoglobin A1c
      (HbA1c) as the main outcome, and other selected cardiometabolic, body composition and quality
      of life markers, as secondary outcomes. This investigation aims to increase the current
      knowledge on HIIT and the related benefits on diabetes control and treatment in a time saving
      and physiological efficient framework, which will improve the general health and well-being
      of the diabetes population. A total of 105 participants with T2D will be recruited from the
      Lisbon area (35 control, 35 HIIT, and 35 MCT). The investigators hypothesize that
      high-intensity interval training, compared to moderate continuous training, will optimize the
      physiological adaptations and quality of life in people with type 2 diabetes.
    

Detailed description: 
      Contemporary exercise guidelines focus on continuous aerobic exercise using mainly moderate
      intensity exercises. However, there is growing evidence that HIIT has the same (or even
      further) benefits, with lower time commitment. This type of exercise has already been tested
      in T2D patients, using mostly short intervention studies, with significant improvements in
      relevant outcomes for T2D, such as glucose regulation. On the other hand, no study as yet
      compared the effects of HIIT and MCT (both combining resistance training, RT) in a long-term
      study design. Therefore, this study will use a 12 month randomized control trial to assess
      the effects of an HIIT combined with RT, and MCT combined with RT, in comparison with a
      control group (home base program), on glycemic control, inflammatory profile, endothelium
      function, cardiorespiratory fitness, quality of life, and body composition outcomes, in adult
      males and females with T2D.

      The sample recruitment is planned to be made using media, mails, and community events.
      Participants can be considered eligible if age is set between 30 and 75 years old, a body
      mass index lower than 48 kg/m2, and if they have been diagnosed with T2D (according to the
      ADA criteria). Further criteria will be made upon their medical history concerning strokes,
      advanced neuropathy or retinopathy, and other health conditions that may interfere with this
      study's protocols or otherwise safe exercising. Power and sample size calculations (G-Power,
      Version 3.1.3) are based on a predicted hemoglobinA1c difference of 0.66 hemoglobinA1c units
      with an SD of effect of 1.2 hemoglobinA1c units, α=0.05, 1-β=0.80 and an expected dropout
      rate of 10%. The calculations yielded a minimum sample size of 105 participants (35 in each
      group).

      The statistical analysis will be performed using SPSS Statistics (version 22.0, SPSS Inc., an
      IBM Company, Chicago IL, USA). Baseline differences between the interventions and the control
      group will be examined using ANOVA, or a non-parametric alternative in case of a
      non-normalized distribution. Outcome variables will be analyzed using three-way mixed
      factorial ANOVA. Intention-to-treat analysis will be performed. Simple and multiple
      regression analysis will be performed to test the relationships among the selected variables.
      Statistical significance will be set at p<0.05.
    

Intervention name(s): MCT combined with RT Group; HIIT combined with RT Group
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 2 Diabetes; Exercise; High Intensity Interval Training; Glycemic Control