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Time Efficient Exercise in Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High intensity interval training
Sprint interval training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Exercise, Risk factors, Exercise therapy, Hemoglobin A, Glycosylated

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 20-65 years
  • diagnosed with type 2 diabetes within the past 10 years
  • no use of insulin.

Exclusion Criteria:

  • known cardiovascular disease- or lung disease, coronary artery disease
  • untreated hypertension of ≥140/90 mmHg
  • orthopaedic or neurological restrictions
  • severe obesity (BMI ≥35)
  • pregnancy
  • unability to exercise
  • drug- or alcohol abuse
  • reluctance to sign the consent form
  • more reported physical active than recommended in current exercise guidelines

Sites / Locations

  • Department Circulation and Medical Imaging, NTNU

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

High intensity interval training

Sprint interval training

Arm Description

High intensity interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 10x1-minute intervals at 90 % of HRmax, with 75 seconds of active recovery at 70 % of HRmax between each interval. Exercise is completed with a three minute cool down. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention.

Sprint interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 2x20 seconds of maximum intensity intervals, with 3 minutes and 20 seconds of active recovery at 70 % of HRmax between each interval, followed by 3 minutes cooling down at the same intensity. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention.

Outcomes

Primary Outcome Measures

Glycosylated hemoglobin (HbA1c)

Secondary Outcome Measures

Full Information

First Posted
January 7, 2015
Last Updated
June 13, 2016
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02340260
Brief Title
Time Efficient Exercise in Type 2 Diabetes
Official Title
Effects of Time Efficient Low-volume Interval Exercise on Cardiometabolic Risk Factors in Individuals With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Exercise is considered a cornerstone in the prevention and treatment of type 2 diabetes, but few patients exercise according to guidelines. In this study the effect of two time efficient high intensity exercise protocols on glycemic control and other cardiometabolic risk factors are investigated in patients with type 2 diabetes.The investigators assume that glycemic control is improved more by low-volume high intensity interval training than by extremely low-volume sprint interval training.
Detailed Description
The world prevalence of diabetes mellitus for 2010 is estimated to 6.4 % of the adult population, and an increase up to 7.7 % is expected before 2030. 90-95 % individuals with diabetes have type 2 diabetes (T2D). The complications of T2D lead to substantially increased risk of hypertension, cardiovascular disease (CVD) and the development of heart failure. CVD is the most common cause of death in European adults with diabetes, and the risk of developing CVD is double of that observed in individuals without diabetes. Lowering HbA1c in type 2 diabetes decreases the absolute risk of developing CVD by 5-17 %, as well as decreasing all-cause mortality by 6-15 %. Individuals with T2D are recommended to exercise moderately or vigorously for at least 150 minutes per week. However, the majority of adults fail to meet the guidelines for even the minimum amount of physical activity, and lack of time is often cited as the main reason. This research group has previously shown that 4x4 minute high intensity aerobic interval training (AIT) yields significantly greater response on HbA1c, BMI and diastolic dysfunction in patients with T2D with duration <10years in contrast to present recommendations. AIT reduces cardiovascular risk factors more than moderate continuous training in patients with heart failure and metabolic syndrome. In metabolic syndrome, AIT is superior in enhancing endothelial function, insulin signaling in fat and skeletal muscle and in reducing blood glucose. This shows that AIT is a time-efficient and highly effective form of exercise for both patients with T2D and other patient groups. Recently, even lower training volumes than made use of in the projects presented above, have shown indications of improving glycaemic control in T2D. Only two weeks with a total of six sessions of high intensity training reduces blood glucose significantly in individuals with T2D. Even shorter intervals of all-out activity (2-7 bouts of 20-30 seconds of supramaximal ergometer cycling) was shown to improve both aerobic capacity and a number of metabolic and cardiovascular risk factors after few weeks of training. However, low-volume high-intensity exercise studies are limited for T2D. The present study aims to compare the effect of two time saving, high intensity exercise protocols on cardiovascular risk factors in patients with type 2 diabetes. The investigators assume that glycemic control is improved more by low-volume high intensity interval training than by extremely low-volume sprint interval training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Exercise, Risk factors, Exercise therapy, Hemoglobin A, Glycosylated

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval training
Arm Type
Other
Arm Description
High intensity interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 10x1-minute intervals at 90 % of HRmax, with 75 seconds of active recovery at 70 % of HRmax between each interval. Exercise is completed with a three minute cool down. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention.
Arm Title
Sprint interval training
Arm Type
Other
Arm Description
Sprint interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 2x20 seconds of maximum intensity intervals, with 3 minutes and 20 seconds of active recovery at 70 % of HRmax between each interval, followed by 3 minutes cooling down at the same intensity. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention.
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training
Intervention Description
High intensity exercise during 12 weeks with three weekly training sessions
Intervention Type
Behavioral
Intervention Name(s)
Sprint interval training
Intervention Description
Sprint interval exercise during 12 weeks with three weekly training sessions
Primary Outcome Measure Information:
Title
Glycosylated hemoglobin (HbA1c)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 20-65 years diagnosed with type 2 diabetes within the past 10 years no use of insulin. Exclusion Criteria: known cardiovascular disease- or lung disease, coronary artery disease untreated hypertension of ≥140/90 mmHg orthopaedic or neurological restrictions severe obesity (BMI ≥35) pregnancy unability to exercise drug- or alcohol abuse reluctance to sign the consent form more reported physical active than recommended in current exercise guidelines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toril A Nagelhus Hernes, prof
Organizational Affiliation
Department Circulation and Medical Imaging, NTNU
Official's Role
Study Director
Facility Information:
Facility Name
Department Circulation and Medical Imaging, NTNU
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27274669
Citation
Revdal A, Hollekim-Strand SM, Ingul CB. Can Time Efficient Exercise Improve Cardiometabolic Risk Factors in Type 2 Diabetes? A Pilot Study. J Sports Sci Med. 2016 May 23;15(2):308-13. eCollection 2016 Jun.
Results Reference
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Time Efficient Exercise in Type 2 Diabetes

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