Blood-flow restriction training to improve insulin sensitivity in type 2 diabetes
Metabolic Effects of a New Resistance Training in Individuals With Type 2 Diabetes
NA · German Diabetes Center · NCT04222231
This study tests if blood-flow restriction training can help people with type 2 diabetes improve their insulin sensitivity and overall health compared to regular resistance training.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 30 Years to 69 Years |
| Sex | All |
| Sponsor | German Diabetes Center (other) |
| Locations | 1 site (Düsseldorf, NRW) |
| Trial ID | NCT04222231 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of blood-flow restriction resistance training (BFRT) compared to classical resistance training on metabolic and cardiovascular health in individuals with type 2 diabetes over a 12-week period. The research focuses on how these training methods can enhance insulin sensitivity and muscle function, which are critical for managing diabetes. Participants will engage in either high-load or low-load resistance training while their metabolic responses will be closely monitored. The study aims to provide insights into effective exercise strategies for improving health outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 30 to 69 years with a diagnosis of type 2 diabetes and a BMI between 19 and 40 kg/m².
Not a fit: Patients with acute infections, significant weight fluctuations, or serious cardiovascular, respiratory, or metabolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance insulin sensitivity and overall metabolic health in patients with type 2 diabetes.
How similar studies have performed: Previous studies have shown promising results with blood-flow restriction training in various populations, suggesting potential benefits for individuals with type 2 diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female, age between ≥ 30 and ≤ 69 years * Individuals with type 2 diabetes * BMI: 19-40 kg/m² Exclusion Criteria: * Acute infections in the last 2 weeks * Weight fluctuations (\> 10% in the last 6 month) * Therapy with Glitazone, Beta blocker, Insulin * Malignant cancer * Heart diseases (angina pectoris, myocardial infarction, acute myocarditis or pericarditis, cardiac wall aneurysms/ stenose, untreated hypotension or hypertension, aortic stenosis, stroke, cardiac insufficiency, NYHA-class ≥II, heart arrhythmia, disturbances of blood circulation in extremities, venous insufficiency, varicose veins) * Diabetic neuropathy * Respiratory disease (COPD, Gold grade ≥II) * Serious heart, kidney or liver disease: - New York Heart Association-Classification (NYHA) stage ≥ II - creatinine ≥ 1.6 mg / dl - Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≥ two-fold upper reference value * Anemia (Hb \<12g / l), blood donation in the last 3 month * Disease of the immune system (leucocytes \<5000/μl) * Application of immunomodulatory agents (Glucocorticoids, Antihistamine, Acetylsalicylic acid) * Application of antithrombotic agents (Anticoagulant) * Blood clotting disorders (abnormally levels of thrombocytes \[\<150.000, \>450.000 ± 50 \], Partial thromboplastin time (PTT) \[26-36 s ± 5 s\], Quick \[70-120% ± 10%\]) or wound healing * Thyroid disease (untreated hypothyroidism or hyperthyroidism, treatment with thiamazol) * Epilepsy * Application of drugs which can manipulate the thermoregulation (Antipsychotic) * Rosacea * Vitamine supplement (with the las 4 weeks) * Cigarettes (or non-smokers \<1 year) alcohol consumption (men\> 30 g / d, women\> 20 g / d), drug abuse * Severe psychiatric illness or addiction * Risk for/ or HIV or Hepatitis B or C * Shift work or anormal circadian rhythm * Muscle diseases, orthopedic restrictions * Hypersensitivity to local anaesthetic * Pregnancy, lactation * Metallic and magnetic implants (for example, mechanical heart valves, joint prostheses, clip after vascular surgery, middle and inner ear implants or fresh dental implants) * Claustrophobia * Hypohidrosis * Participation in another intervention study within the last 3 month
Where this trial is running
Düsseldorf, NRW
- German Diabetes Center — Düsseldorf, NRW, Germany (RECRUITING)
Study contacts
- Study coordinator: Michael Roden, Prof., MD
- Email: Michael.Roden@ddz.de
- Phone: 00492113382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Insulin sensitivity, Blood flow restriction training, Muscle hypertrophy, Muscle Strength, Hypoxia