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

Type 2 Diabetes Clinical Trial

— HIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039934
• Other study ID #: HIT and insulin sensitivity
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: August 2018

Study information

• Verified date: August 2023
• Source: German Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High intensity interval training is applied for several diseases.

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Germany	German Diabetes Center	Düsseldorf	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
German Diabetes Center

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Insulin sensitivity by high intensity interval training	High intensity interval training leads to significant improvements in insulin action and oxidative phosphorylation in skeletal muscle.	2 years

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