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

September 7, 2012
January 16, 2014
July 2013
March 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02039934 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes
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.

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

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes
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.

Experimental: high intensity interval training
Intervention: Other: High intensity interval training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
30 Years to 65 Years
Yes
Contact: Julia Szendrödi, MD, PhD 0049 211 3382 203 julia.szendroedi@ddz.uni-duesseldorf.de
Germany
 
NCT02039934
HIT and insulin sensitivity
No
julia szendrödi, German Diabetes Center
German Diabetes Center
Not Provided
Principal Investigator: Julia Szendrödi, MD, PhD German Diabetes Center
German Diabetes Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP