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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Physical training

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).

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus Universityhospital, Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type 2 diabetic subjects; Type 2 diabetic subjects physical training (interval training 3 times at week) in a period of 8 weeks.	Other: Physical training; 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.
Experimental: Healthy subjects; Healthy subjects physical training (interval training 3 times at week) in a period of 8 weeks.	Other: Physical training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	baseline and 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle and fat mass	Change from baseline and 8 weeks in Muscle and fat mass (DEXA Scan)	baseline and 8 weeks
blood flow	Change from baseline and 8 weeks in blood flow at rest around the thigh muscles (Ultra Sound technic)	baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Estimate): February 3, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Insulin resistance; Type 2 diabetes; Interval training; fat metabolism
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: T2D-training; Aarhus University (Other Identifier: Aarhus University)