Impact of Different Types of Exercise Training on Biochemical Markers of Insulin-dependent Patients

NCT02939768 | Completed

• 1 other identifier: 53935916.9.0000.5347
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Type 1 diabetes mellitus (T1DM) is characterized by the destruction of β cells and consequent loss of insulin secretion due an autoimmune process, being associated with increased cardiovascular risk, oxidative stress and inflammation. Considering that most people with T1DM do not reach recommended levels of physical activity due to concern about the rapid drop in blood sugar and the excuse of "lack of time", shorter sessions of exercise that provide several benefits should be encouraged. Thus, this work aims to compare the effects of high-intensity interval training (HIIT), strength training (ST) and both interventions on several blood markers and functional parameters in T1DM patients. Study hypothesis: (1) ST+HIIT will be more beneficial than HIIT, which in turn will be more beneficial than ST, on modification of blood levels of pro and anti-inflammatory, pro and antioxidant, lipid, renal and glucose metabolism parameters and (2) ST+HIIT will be more beneficial than HIIT, which in turn will be more beneficial than ST, on modification of functional parameters, body composition and maximal oxygen uptake.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

• Glycated haemoglobin (HbA1c)

  HbA1c levels will be determined in the automated analyzer.

  End of 10-week exercise period

• Tumor necrosis factor alpha (TNF-α)

  The plasma levels of TNF-α will be determined by enzyme-linked immunosorbent assay using commercial kits for human, according to manufacturer's instructions.

  End of 10-week exercise period

• Mitochondrial superoxide dismutase (MnSOD) activity

  MnSOD isoform activity will be measured spectrophotometrically in mononuclear cells supernatants, according to a method previously described.

  End of 10-week exercise period

Study Arms (2)

Exercise training protocols

EXPERIMENTAL

Participants will be randomized in one of three groups: HIIT, ST or ST combined with HIIT (ST+HIIT). Each training protocol will last 10 weeks, being the initial two weeks designed to participants' gradual adaptations to respective training protocol, with sessions performed three times per week in non-consecutive days.

Other: High-intensity interval training (HIIT); Other: Strength training (ST); Other: ST combined with HIIT (ST+HIIT)

Control period

NO INTERVENTION

Before interventions (exercise training protocols), all participants will participate of a control period lasting one month, where participants will be encouraged to maintain their habitual lifestyle and usual diet habits.

Interventions

High-intensity interval training (HIIT) OTHER

The HIIT sessions will be performed on cycle ergometers and will be consisted of 10 x 60-s cycling intervals interspersed with 60 s recovery. Individual workloads will be selected to elicit \~90% maximal heart rate attained in the cardiorespiratory fitness test (HRmax). A passive or active recovery will be given among high-intensity stimulus. Each training session will include 3-min warm-up and 2-min cool-down phase performed \~50% (HRmax), totalling 25 min. This intervention will last 10 weeks.

Exercise training protocols

Strength training (ST) OTHER

ST protocol will consist of three sets performed at maximum weight that participants could move eight times with good technique in the following exercises: supine bench press (pectoralis major), leg press (quadriceps, biceps femoris, gluteus maximus), lat pulldown (latissimus dorsi), leg extension (quadriceps), shoulder press (deltoids), leg curl (biceps femoris) and abdominal crunch (abdominal muscles). It will be given 1-min rest between series, totalizing approximately 35 min of ST. This intervention will last 10 weeks.

Exercise training protocols

ST combined with HIIT (ST+HIIT) OTHER

Participants in the ST+HIIT group will execute ST and HIIT (in this order) above described in the same training session, lasting approximately 60 min. This intervention will last 10 weeks.

Exercise training protocols

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HbA1c \< 10%;
• Have lived with T1DM for at least four years;
• Physically inactive status (\< 150 min of self-reported structured physical activity per week in the previous three months).

You may not qualify if:

• Creatinine \> 1,3 mg/dL;
• Cardiovascular diseases;
• Retinopathy;
• Severe musculoskeletal injuries;
• Recent infections;
• Use of antioxidant supplements.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (2)

• Eckstein ML, Farinha JB, McCarthy O, West DJ, Yardley JE, Bally L, Zueger T, Stettler C, Boff W, Reischak-Oliveira A, Riddell MC, Zaharieva DP, Pieber TR, Muller A, Birnbaumer P, Aziz F, Brugnara L, Haahr H, Zijlstra E, Heise T, Sourij H, Roden M, Hofmann P, Bracken RM, Pesta D, Moser O. Differences in Physiological Responses to Cardiopulmonary Exercise Testing in Adults With and Without Type 1 Diabetes: A Pooled Analysis. Diabetes Care. 2021 Jan;44(1):240-247. doi: 10.2337/dc20-1496. Epub 2020 Nov 12.

  PMID: 33184152 DERIVED

• Farinha JB, Ramis TR, Vieira AF, Macedo RCO, Rodrigues-Krause J, Boeno FP, Schroeder HT, Muller CH, Boff W, Krause M, De Bittencourt PIH Jr, Reischak-Oliveira A. Glycemic, inflammatory and oxidative stress responses to different high-intensity training protocols in type 1 diabetes: A randomized clinical trial. J Diabetes Complications. 2018 Dec;32(12):1124-1132. doi: 10.1016/j.jdiacomp.2018.09.008. Epub 2018 Sep 19.

  PMID: 30270019 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

High-Intensity Interval Training; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

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

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 20, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)