Clinical trial NCT02039934: Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes
Official title: Effect of High-intensity Low-volume Training on Insulin Sensitivity in Patients With Type 2 Diabetes and Healthy Lean Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
exercise intervention
high intensity interval training
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: High intensity interval training is applied for several diseases.

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

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 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

Primary outcomes:
measure: Improvement of Insulin sensitivity by high intensity interval training
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: German Diabetes Center
state: Nordrhein-Westfalen
Study officials:
affiliation: German Diabetes Center
name: Michael Roden, Prof., MD
role: STUDY_DIRECTOR
References:
citation: Apostolopoulou M, Mastrototaro L, Hartwig S, Pesta D, Strassburger K, de Filippo E, Jelenik T, Karusheva Y, Gancheva S, Markgraf D, Herder C, Nair KS, Reichert AS, Lehr S, Mussig K, Al-Hasani H, Szendroedi J, Roden M. Metabolic responsiveness to training depends on insulin sensitivity and protein content of exosomes in insulin-resistant males. Sci Adv. 2021 Oct 8;7(41):eabi9551. doi: 10.1126/sciadv.abi9551. Epub 2021 Oct 8.