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

Type 2 Diabetes Clinical Trial

— DIATRAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333734
• Other study ID #: T2D-training
• Secondary ID: Aarhus Universit
• Status: Completed
• Phase: N/A
• First received: July 8, 2014
• Last updated: February 2, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus Universityhospital, Aarhus University	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle and fat mass	Change from baseline and 8 weeks in Muscle and fat mass (DEXA Scan)	baseline and 8 weeks	No
Other	blood flow	Change from baseline and 8 weeks in blood flow at rest around the thigh muscles (Ultra Sound technic)	baseline and 8 weeks	No
Primary	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	No
Secondary	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	No