Effect of High-intensity Low-volume Tra… | Clinical Trial

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Interval Training

Other

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Registry information

Official study title

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

Acronym: HIT

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Jan 20, 2014
Registry last updated: Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed