Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes (HIT)

August 7, 2023 updated by: German Diabetes Center

Effect of High-intensity Low-volume Training on Insulin Sensitivity in Patients With Type 2 Diabetes and Healthy Lean Subjects

High intensity interval training is applied for several diseases.

Hypothesis: High intensity interval training improves insulin sensitivity in patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes mellitus is a multifactorial metabolic disease that is characterized by reduced insulin sensitivity and insulin production leading to impaired glucose tolerance. Overweight and low physical activity are the main risk factors for the development of type 2 diabetes. Increased physical activity has shown to improve insulin sensitivity, hence, exercise plays a significant role in the prevention and therapy of type 2 diabetes. This study aims at investigating the acute and chronic effects of high-intensity low-volume training, that consists of brief bursts of very vigorous exercise separated by recovery periods, on metabolic function in patients with type 2 diabetes, people at high risk for the disease and healthy, lean individuals. Study participants take part in 30 min training session three times a week for a period of 12 weeks. Participants are studied on four occasions, prior to the intervention, after an acute bout of exercise as well as after 6 and 12 weeks of training in order to assess physical fitness, body composition, insulin sensitivity, energy metabolism in muscle, adipose tissue inflammation and neurological function. It is hypothesized that this type of exercise leads to significant improvements in insulin action and oxidative phosphorylation in muscle

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
        • German Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Men and women
  • Age: 30 - 65 years
  • Typ-2-Diabetes (BMI > 25 kg/m²)
  • Increased risk for diabetes (BMI >25 kg/m²)

Exclusion criteria:

  • Acute Infection within the last 2 weeks prior to the intervention
  • Autoimmune diseases and immune suppressive diseases (Leukocytes < 5000/μl)
  • Intake of immunomodulating drugs (Glucocorticoids, Antihistamine, ASS)
  • Pregnancy, Breastfeeding, Menstruation
  • Kidney insufficiency (Creatinine > 1,5 mg/dl)
  • Cardiovascular diseases
  • Anemia (Hb < 12g/l), disorders of wound healing or blood clotting
  • Participation in another study within the last 2 months before the investigation
  • Metallic or magnetic items on or in the body
  • Claustrophobia
  • Thyroid dysfunction
  • Intake of glitazones or insulin therapy
  • Smoking (Non-smoking since > 1 year), alcohol consumption (Men > 30 g/d, Women > 20g/d) or illegal drugs
  • Psychiatric disorders
  • Risk for/or manifest AIDS (HIV) or Hepatitis B or C
  • Night shift working
  • Hypersensitivity to local anesthetics
  • Cancer disease
  • Lung diseases
  • Systematic endurance training (>1x per week > 60min.)
  • Maximal oxygen consumption (VO2 max) <20ml/min/kg
  • Orthopedic disorders
  • Musculoskeletal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high intensity interval training
30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week
Other: High intensity interval training

The intervention consists of 30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week.

Training program: After 5 minutes of warm-up the subject cycles for 10 intervals of 60 s. at 90 % maximum effort separated 60 s at 20% maximum effort, based on a previously performed spiroergometry, followed by 5 minutes of cool-down.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Insulin sensitivity by high intensity interval training
Time Frame: 2 years
High intensity interval training leads to significant improvements in insulin action and oxidative phosphorylation in skeletal muscle.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Diabetes Center

Investigators

  • Study Director: Michael Roden, Prof., MD, German Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimated)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIT and insulin sensitivity

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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