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

This study is currently recruiting participants.
Verified September 2017 by julia szendrödi, German Diabetes Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02039934
First Posted: January 20, 2014
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
julia szendrödi, German Diabetes Center
  Purpose

High intensity interval training is applied for several diseases.

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


Condition Intervention
Type 2 Diabetes Other: High intensity interval training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of High-intensity Low-volume Training on Insulin Sensitivity in Patients With Type 2 Diabetes and Healthy Lean Subjects

Resource links provided by NLM:


Further study details as provided by julia szendrödi, German Diabetes Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high intensity interval training 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.


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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039934


Contacts
Contact: Julia Szendrödi, MD, PhD 0049 211 3382 203 julia.szendroedi@ddz.uni-duesseldorf.de

Locations
Germany
Deutsches Diabetes Zentrum Recruiting
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Contact: Julia Szendrödi, MD, PhD    0049 211 3382 203    julia.szendroedi@ddz.uni-duesseldorf.de   
Sponsors and Collaborators
German Diabetes Center
Investigators
Principal Investigator: Julia Szendrödi, MD, PhD German Diabetes Center
  More Information

Additional Information:
Responsible Party: julia szendrödi, MD, PhD, German Diabetes Center
ClinicalTrials.gov Identifier: NCT02039934     History of Changes
Other Study ID Numbers: HIT and insulin sensitivity
First Submitted: September 7, 2012
First Posted: January 20, 2014
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by julia szendrödi, German Diabetes Center:
type 2 diabetes
exercise intervention
high intensity interval training

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs