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Comparing Moderate and High-intensity Interval Training Protocols on Biomarkers in Type 2 Diabetes Patients (D2FIT)

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ClinicalTrials.gov Identifier: NCT03144505
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Associação Protectora dos Diabéticos de Portugal
Information provided by (Responsible Party):
Luís Bettencourt Sardinha, University of Lisbon

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: MCT combined with RT Group Behavioral: HIIT combined with RT Group Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A 12-Month Randomized Control Trial in Patients With Type 2 Diabetes: Comparing Moderate and High-intensity Interval Training Protocols on Biomarkers and Quality of Life
Study Start Date : February 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
The control group will be invited to an orientation session, where it will be provided detailed information concerning their home base exercise program. Additionally, once in every 4 weeks, the control group will meet for thematic sessions regarding diabetes topics, such as, nutrition, physical activity, and clinical complications. Due to ethical reasons, the control group needs to be provided with a standard counseling approach, as suggested in this research project.
Experimental: MCT combined with RT Group

MCT Group is designed to have equal energy expenditure when compared with HIIT Group. We standardized the exercise prescription according to body weight (kg), predicting that physical activity guidelines of 150 min peer week moderate intensity is equivalent to 10 kcal/kg of a combined session of RT and MCT. The MCT group will perform continuous cycling 3 days per week, with an exercise intensity of 40 to 59% of the heart rate reserve (HRR).

Participants will also perform an RT circuit: 1 set of two pull upper body exercises (seated row and lat pulldown); 1 set of two push upper body exercises (chest press and shoulder press); 1 set of two leg exercises (leg press and one leg lunge); and 1 set of two core exercises (dead bug and regular plank). Each set consisting in 10 to 12 repetitions.

 Behavioral: MCT combined with RT Group
Experimental: HIIT combined with RT Group

The HIIT program will perform cycle ergometer 3 days a week, and it will be divided into three phases: preparation phase (weeks 1-4), where the participants perform MCT (40-59% of the HRR); transition phase (weeks 5-8), in which the HIIT program is introduced progressively, starting with bouts of 2 minutes at 70% of the HRR, followed by 1 minute at 40-59% of the HRR (weeks 5-6), and finishing with bouts of 80% of the HRR, followed by 1 minute at 40-59% of the HRR (weeks 7-8); training phase (weeks 9-42), where the participants perform 1 minute of exercise at 90% of the HRR, followed by 1 minute resting at 40-59% of the HRR.

The HIIT session will have the same energy expenditure as the MCT group, using the 10kcal/kg week target. Participants will also fulfill the same RT as the MCT group.

 Behavioral: HIIT combined with RT Group


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline HbA1c at 3, 6, 9 and 12 months [ Time Frame: 12 months ]
    Blood samples will be collected from an indwelling catheter for the assessment of HbA1c. Samples will be drawn into chilled, heparinized tubes and centrifuged rapidly to avoid glycolysis. HbA1c will be analyzed by immunoassay (auto analyzer Hb9210 Premier A. Menarini diagnostics).


Secondary Outcome Measures :
  1. Changes from baseline cardiorespiratory fitness at 12 months [ Time Frame: 12 months ]
    A stress test with ECG and gas analysis will be performed to assess cardiorepiratory fitness and to screen for eventual heart problems, under the supervision of appropriately trained medical staff.

  2. Changes from baseline body composition at 3, 6, 9 and 12 months [ Time Frame: 12 months ]
    Subjects weight and height will be measured according to standardized procedures. Waist circumference measurements will be done according to the NIH and WHO protocol. To estimate total and intra-abdominal fat mass and fat-free mass, DXA measurements will be made using a total body scan (Hologic Explorer-W, Waltham, USA).

  3. Changes from baseline inflammatory profile at 12 months [ Time Frame: 12 months ]
    This analysis will be done in standard inflammatory variables such as TNFα, PCR, IL-6 and cortisol.

  4. Changes from baseline arterial function at 12 months [ Time Frame: 12 months ]
    Arterial function assessment will be performed on the right carotid artery using an ultrasound scanner (MyLab One, Esaote, Genova, Italy) and implemented with a previously validated radiofrequency-based tracking of the arterial wall.

  5. Changes from baseline quality of Life at 12 months [ Time Frame: 12 months ]
    Quality of life will be measured using the SF-36 Health Survey.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women diagnosed with type 2 diabetes
  • 30-75 years of age
  • BMI < 48 kg/m2

Exclusion Criteria:

  • Documented cardiovascular disease
  • Advanced neuropathy or retinopathy
  • Physical health condition that may interfere with study's protocols or exercising safety
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144505


Sponsors and Collaborators
University of Lisbon
Associação Protectora dos Diabéticos de Portugal
Investigators
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Study Director: Luís Sardinha, Professor Professor
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Luís Bettencourt Sardinha, Professor, University of Lisbon
ClinicalTrials.gov Identifier: NCT03144505    
Other Study ID Numbers: SFRH/BD/85742/2012
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Keywords provided by Luís Bettencourt Sardinha, University of Lisbon:
Type 2 Diabetes
Exercise
High Intensity Interval Training
Glycemic Control
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases