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Investigation of the Effect of 8-week Controlled High Intense Interval Training in Type 2 Diabetic Patients (DIATRAIN)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical training
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Interval training, Insulin resistance, fat metabolism

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Type 2 diabetes or matched healthy controls. T2D subject only : HbA1c > 7,3. All subjects have an age between 40-65 years and a body mass index between 25-40 kg/m2. Both genders is allowed

Exclusion Criteria:

  • Severe diseases /immobility

Sites / Locations

  • Aarhus Universityhospital, Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Type 2 diabetic subjects

Healthy subjects

Arm Description

Type 2 diabetic subjects physical training (interval training 3 times at week) in a period of 8 weeks.

Healthy subjects physical training (interval training 3 times at week) in a period of 8 weeks.

Outcomes

Primary Outcome Measures

Oral Glucose tolerance test (OGTT)
Change from baseline and 8 weeks in glucose/insulin response from a 2.5 hours oral glucose tolerance test (iAUC) after 8 weeks training

Secondary Outcome Measures

Physical fitness
Change from baseline and after 8 weeks in physical fitness level (mL/min x kg) measured with submaximal test using a bicycle ergometer after 8 weeks interval training .

Full Information

First Posted
July 8, 2014
Last Updated
February 2, 2015
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02333734
Brief Title
Investigation of the Effect of 8-week Controlled High Intense Interval Training in Type 2 Diabetic Patients
Acronym
DIATRAIN
Official Title
Investigation of the Effect of 8-week Controlled High Intense Interval Training in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall objective of this study is to examine the blood flow in the thigh muscles and sugar metabolism before and after 8 weeks of high intensity interval training (HIIT) on a bicycle ergometer in patients with type 2 diabetes (T2D) and matched controls. The following parameters are included in the assessment: Sugar Metabolism Muscle and fat mass The blood flow at rest around the thigh muscles Oxygen uptake test on a bicycle ergometer and 5 km time trial
Detailed Description
Type 2 diabetes (T2D) can be defined as a bihormonal metabolic disorder characterised by insufficient insulin secretion and abnormal glucagon secretion. It is however well established that physical activity per se improves glucose and may postpone or even slow down in the diabetic population. Glycaemic control may be improved more by high intensity interval training than by intensities from existing recommended guidelines. Additionally, there seems to be accumulating evidence that high intensity interval training induces increased overall fat and abdominal fat mass loss as opposed to traditional continuous endurance training Therefore we hypothesise that 3 weekly sessions of high intensity interval training (10×60 sec. at an intensity inducing 90% of maximal heart frequency with a recovery of 60 sec. between each bout) over 8 weeks improves overall glycaemic control (glucose, insulin and glucagon), inflammatory status (interleukins, cytokines, chemokines and cell adhesion molecules) and blood flow (NO and PGI2 vasodilatory capabilities).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Interval training, Insulin resistance, fat metabolism

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Type 2 diabetic subjects
Arm Type
Experimental
Arm Description
Type 2 diabetic subjects physical training (interval training 3 times at week) in a period of 8 weeks.
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Healthy subjects physical training (interval training 3 times at week) in a period of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Physical training
Intervention Description
Performed supervised high intensity interval training 3 times a week over 8 weeks on a bicycle ergometer (with watt meter). During the training period, the trainee individually established program, each time with 10 × 60 sec. workout (interspersed with 60 sec. break) corresponding to a force which during the test cycle induces ~ 90% of the maximum heart rate. The time spent per session is expected to last ~ 25 minutes.
Primary Outcome Measure Information:
Title
Oral Glucose tolerance test (OGTT)
Description
Change from baseline and 8 weeks in glucose/insulin response from a 2.5 hours oral glucose tolerance test (iAUC) after 8 weeks training
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Physical fitness
Description
Change from baseline and after 8 weeks in physical fitness level (mL/min x kg) measured with submaximal test using a bicycle ergometer after 8 weeks interval training .
Time Frame
baseline and 8 weeks
Other Pre-specified Outcome Measures:
Title
Muscle and fat mass
Description
Change from baseline and 8 weeks in Muscle and fat mass (DEXA Scan)
Time Frame
baseline and 8 weeks
Title
blood flow
Description
Change from baseline and 8 weeks in blood flow at rest around the thigh muscles (Ultra Sound technic)
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes or matched healthy controls. T2D subject only : HbA1c > 7,3. All subjects have an age between 40-65 years and a body mass index between 25-40 kg/m2. Both genders is allowed Exclusion Criteria: Severe diseases /immobility
Facility Information:
Facility Name
Aarhus Universityhospital, Aarhus University
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26258597
Citation
Madsen SM, Thorup AC, Overgaard K, Jeppesen PB. High Intensity Interval Training Improves Glycaemic Control and Pancreatic beta Cell Function of Type 2 Diabetes Patients. PLoS One. 2015 Aug 10;10(8):e0133286. doi: 10.1371/journal.pone.0133286. eCollection 2015.
Results Reference
derived

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Investigation of the Effect of 8-week Controlled High Intense Interval Training in Type 2 Diabetic Patients

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