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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by German Diabetes Center
Sponsor:
Information provided by (Responsible Party):
julia szendrödi, German Diabetes Center
ClinicalTrials.gov Identifier:
NCT02039934
First received: September 7, 2012
Last updated: January 16, 2014
Last verified: January 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 German Diabetes Center:

Primary Outcome Measures:
  • Improvement of Insulin sensitivity by high intensity interval training [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 2015
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: julia szendrödi, MD, PhD, German Diabetes Center
ClinicalTrials.gov Identifier: NCT02039934     History of Changes
Other Study ID Numbers: HIT and insulin sensitivity
Study First Received: September 7, 2012
Last Updated: January 16, 2014
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014