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

Type 2 Diabetes Clinical Trial

— D2FIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144505
• Other study ID #: SFRH/BD/85742/2012
• Status: Completed
• Phase: N/A
• First received: April 28, 2017
• Last updated: May 5, 2017
• Start date: February 2014
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• MCT combined with RT Group

• HIIT combined with RT Group

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Lisbon	Associação Protectora dos Diabéticos de Portugal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline HbA1c at 3, 6, 9 and 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).	12 months
Secondary	Changes from baseline cardiorespiratory fitness at 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.	12 months
Secondary	Changes from baseline body composition at 3, 6, 9 and 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).	12 months
Secondary	Changes from baseline inflammatory profile at 12 months	This analysis will be done in standard inflammatory variables such as TNFa, PCR, IL-6 and cortisol.	12 months
Secondary	Changes from baseline arterial function at 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.	12 months
Secondary	Changes from baseline quality of Life at 12 months	Quality of life will be measured using the SF-36 Health Survey.	12 months