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Completed

NCT Number: NCT02333734

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus Universityhospital, Aarhus University

Aarhus C, 8000, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical training

Other

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 outcomes

  1. Oral Glucose tolerance test (OGTT)

    Time frame: baseline and 8 weeks

    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 outcomes

  1. Physical fitness

    Time frame: baseline and 8 weeks

    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 .

Other outcomes

  1. Muscle and fat mass

    Time frame: baseline and 8 weeks

    Change from baseline and 8 weeks in Muscle and fat mass (DEXA Scan)

  2. blood flow

    Time frame: baseline and 8 weeks

    Change from baseline and 8 weeks in blood flow at rest around the thigh muscles (Ultra Sound technic)

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Acronym: DIATRAIN

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2015
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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