NCT03487029

Brief Summary

Aim: To assess whether there are different training effects on glucose concentration and cardiorespiratory parameters of different high-intensity training protocols in patients with type 2 diabetes. Type 2 diabetes is a highly prevalent disease associated with cardiovascular disease leading to high levels of mortality, morbidity and health expenditure, characterized by impaired glucose control during activities and reduced aerobic exercise capacity . Exercise training is the most effective way to improve compliance, reduce blood glucose concentration and increase insulin sensitivity. Training increases muscle capacity, oxidative capacity and glucose transport, peripheral insulin sensitivity is improved. Exercise training with high-intensity interval (resting and exercise period) High Intensity Interval Training (HIIT) is a form of exercise training that has recently been widely used in the management of type 2 diabetes, including short duration high intensity exercise periods and lower severity or passive rest periods. There are different HIIT exercise training programs according to physiological responses in the literature. However, long-term and short-term HIIT training training programs were not compared in terms of their effect on glucose concentration and cardiorespiratory fitness. The aim of this study was to compare the effects of different HIIT exercise training programs so that exercise programs for patients with type 2 diabetes could be planned more effectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

March 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

February 6, 2018

Last Update Submit

April 7, 2020

Conditions

Diabetes

Keywords

diabeteshigh intensity interval trainingcardiorespiratory fitness

Outcome Measures

Primary Outcomes (1)

  • muscle oxigeneration

    It is evaluate with wearable lactate threshold device on gastrocinemius

    Change from baseline muscle oxigeneration at 8 weeks

Secondary Outcomes (13)

  • The blood glucose consentration

    before and after 8 weeks

  • Functional Exercise capacity

    before and after 8 weeks

  • Maximal exercise capacity

    before and after 8 weeks

  • Symptom limited maximal exercise capacity

    before and after 8 weeks

  • Lipit profile-High density lipoprotein cholesterol

    before and after 8 weeks

  • +8 more secondary outcomes

Study Arms (2)

short duration group

EXPERIMENTAL

30sn %100 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks

Other: Short duration

long duration group

EXPERIMENTAL

4dk %85 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks

Other: Long duration

Interventions

Short durationOTHER

exercise Short duration high intensity training

Also known as: training
short duration group
Long durationOTHER

exercise Long duration high intensity training

Also known as: training
long duration group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of type 2 diabetes
  • aged 18-64 years
  • patients can walk and cooperative
  • body mass index is less than 40 kg / m2

You may not qualify if:

  • Individuals have known lung disease,have undergone any cardiac event or surgery within the past six months, have uncontrolled hypertension, and have diabetic complications such as nephropathy, retinopathy and severe neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, State, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Cemile Bozdemir Özel, McS

    Hacettepe University Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2018

First Posted

April 3, 2018

Study Start

March 2, 2018

Primary Completion

September 20, 2018

Study Completion

January 17, 2020

Last Updated

April 9, 2020

Record last verified: 2020-04

Locations

TU(1)