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

NCT03144505 | Completed

• 1 other identifier: SFRH/BD/85742/2012
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Exercise; High Intensity Interval Training; Glycemic Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes from baseline cardiorespiratory fitness at 12 months

  12 months

• Changes from baseline body composition at 3, 6, 9 and 12 months

  12 months

• Changes from baseline inflammatory profile at 12 months

  12 months

• Changes from baseline arterial function at 12 months

  12 months

• Changes from baseline quality of Life at 12 months

  12 months

Study Arms (3)

Control

NO INTERVENTION

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.

MCT combined with RT Group

EXPERIMENTAL

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

HIIT combined with RT Group

EXPERIMENTAL

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

Interventions

MCT combined with RT Group BEHAVIORAL

MCT combined with RT Group

HIIT combined with RT Group BEHAVIORAL

HIIT combined with RT Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Documented cardiovascular disease
• Advanced neuropathy or retinopathy
• Physical health condition that may interfere with study's protocols or exercising safety

Sponsors & Collaborators

• University of Lisbon: lead
• Associação Protectora dos Diabéticos de Portugal: collaborator

Related Publications (6)

• Correia IR, Hetherington-Rauth M, Magalhaes JP, Judice PB, Rosa GB, Henriques-Neto D, Manas A, Ara I, Silva AM, Sardinha LB. Compensatory mechanisms from different exercise intensities in type 2 diabetes: a secondary analysis of a 1-year randomized controlled trial. Acta Diabetol. 2023 May;60(5):645-654. doi: 10.1007/s00592-023-02038-7. Epub 2023 Feb 2.

  PMID: 36729308 DERIVED

• Magalhaes JP, Hetherington-Rauth M, Judice PB, Correia IR, Rosa GB, Henriques-Neto D, Melo X, Silva AM, Sardinha LB. Interindividual Variability in Fat Mass Response to a 1-Year Randomized Controlled Trial With Different Exercise Intensities in Type 2 Diabetes: Implications on Glycemic Control and Vascular Function. Front Physiol. 2021 Sep 16;12:698971. doi: 10.3389/fphys.2021.698971. eCollection 2021.

  PMID: 34603073 DERIVED

• Judice PB, Magalhaes JP, Hetherington-Rauth M, Correia IR, Sardinha LB. Sedentary patterns are associated with BDNF in patients with type 2 diabetes mellitus. Eur J Appl Physiol. 2021 Mar;121(3):871-879. doi: 10.1007/s00421-020-04568-2. Epub 2021 Jan 2.

  PMID: 33389140 DERIVED

• Magalhaes JP, Santos DA, Correia IR, Hetherington-Rauth M, Ribeiro R, Raposo JF, Matos A, Bicho MD, Sardinha LB. Impact of combined training with different exercise intensities on inflammatory and lipid markers in type 2 diabetes: a secondary analysis from a 1-year randomized controlled trial. Cardiovasc Diabetol. 2020 Oct 7;19(1):169. doi: 10.1186/s12933-020-01136-y.

  PMID: 33028418 DERIVED

• Hetherington-Rauth M, Magalhaes JP, Judice PB, Melo X, Sardinha LB. Vascular improvements in individuals with type 2 diabetes following a 1 year randomised controlled exercise intervention, irrespective of changes in cardiorespiratory fitness. Diabetologia. 2020 Apr;63(4):722-732. doi: 10.1007/s00125-020-05089-5. Epub 2020 Jan 20.

  PMID: 31960071 DERIVED

• Magalhaes JP, Melo X, Correia IR, Ribeiro RT, Raposo J, Dores H, Bicho M, Sardinha LB. Effects of combined training with different intensities on vascular health in patients with type 2 diabetes: a 1-year randomized controlled trial. Cardiovasc Diabetol. 2019 Mar 18;18(1):34. doi: 10.1186/s12933-019-0840-2.

  PMID: 30885194 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Luís Sardinha, Professor

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 8, 2017
• Study Start: February 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05