RESIST! Blood-flow Restriction Resistance Training for Improving Insulin Sensitivity in Type 2 Diabetes
RESIST
Metabolic Effects of a New Resistance Training in Individuals With Type 2 Diabetes
1 other identifier
interventional
24
1 country
1
Brief Summary
The study aims to investigate the metabolic and cardiovascular effects of classical resistance training with high loads and blood-flow restricted training (BFRT) with low loads in individuals with type 2 diabetes over 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Oct 2019
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2019
CompletedFirst Submitted
Initial submission to the registry
December 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedJune 13, 2023
June 1, 2023
4.2 years
December 10, 2019
June 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in insulin sensitivity by blood-flow restriction or classical resistance training
By using hyperinsulinemic-euglycemic clamp technique, changes in the M-value (mg x kg-1 x min-1) will be measured. The m-value represent the glucose infusion rate at a defined level of hyperinsulinemia during a glucose clamp test. The hyperinsulinemic-euglycemic clamp technique will thus be implicated to assess changes in insulin sensitivity before and after 12 weeks of resistance training.
Before and after 12 weeks of training (intervention)
Secondary Outcomes (1)
Changes in skeletal muscle mass by blood-flow restriction or classical resistance training
Before and after 12 weeks of training (intervention)
Other Outcomes (1)
Changes in skeletal muscle strength by blood-flow restriction or classical resistance training
Before and after 12 weeks of training (intervention)
Study Arms (2)
Blood-flow restriction resistance training
EXPERIMENTALResistance training with low loads (15-30% RM) in combination with a brief occlusion of venous blood flow using a tourniquet while exercising.
Classical resistance training
EXPERIMENTALResistance training with high loads (60-80% RM).
Interventions
Training program: After 10 minutes of warm-up the participant performs three exercises with BFRT for the lower extremities. The intensity is about 15-30% of 1-RM.
Training program: After warm-up the participant performs three exercises for lower body. The intensity is about 60-80% of 1-RM.
Eligibility Criteria
You may qualify if:
- Male and female, age between ≥ 30 and ≤ 69 years
- Individuals with type 2 diabetes
- BMI: 19-40 kg/m²
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Related Publications (10)
Christiansen D, Eibye KH, Hostrup M, Bangsbo J. Blood flow-restricted training enhances thigh glucose uptake during exercise and muscle antioxidant function in humans. Metabolism. 2019 Sep;98:1-15. doi: 10.1016/j.metabol.2019.06.003. Epub 2019 Jun 12.
PMID: 31199953BACKGROUNDLoenneke JP, Fahs CA, Rossow LM, Abe T, Bemben MG. The anabolic benefits of venous blood flow restriction training may be induced by muscle cell swelling. Med Hypotheses. 2012 Jan;78(1):151-4. doi: 10.1016/j.mehy.2011.10.014. Epub 2011 Nov 1.
PMID: 22051111BACKGROUNDAbe T, Fujita S, Nakajima T, Sakamaki M, Ozaki H, Ogasawara R, Sugaya M, Kudo M, Kurano M, Yasuda T, Sato Y, Ohshima H, Mukai C, Ishii N. Effects of Low-Intensity Cycle Training with Restricted Leg Blood Flow on Thigh Muscle Volume and VO2MAX in Young Men. J Sports Sci Med. 2010 Sep 1;9(3):452-8. eCollection 2010.
PMID: 24149640BACKGROUNDTakarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.
PMID: 10846023BACKGROUNDTakarada Y, Nakamura Y, Aruga S, Onda T, Miyazaki S, Ishii N. Rapid increase in plasma growth hormone after low-intensity resistance exercise with vascular occlusion. J Appl Physiol (1985). 2000 Jan;88(1):61-5. doi: 10.1152/jappl.2000.88.1.61.
PMID: 10642363BACKGROUNDHughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
PMID: 28259850BACKGROUNDMattocks KT, Jessee MB, Mouser JG, Dankel SJ, Buckner SL, Bell ZW, Owens JG, Abe T, Loenneke JP. The Application of Blood Flow Restriction: Lessons From the Laboratory. Curr Sports Med Rep. 2018 Apr;17(4):129-134. doi: 10.1249/JSR.0000000000000473.
PMID: 29629973BACKGROUNDHarreiter J, Roden M. [Diabetes mellitus-Definition, classification, diagnosis, screening and prevention (Update 2019)]. Wien Klin Wochenschr. 2019 May;131(Suppl 1):6-15. doi: 10.1007/s00508-019-1450-4. German.
PMID: 30980151BACKGROUNDPesta DH, Goncalves RLS, Madiraju AK, Strasser B, Sparks LM. Resistance training to improve type 2 diabetes: working toward a prescription for the future. Nutr Metab (Lond). 2017 Mar 2;14:24. doi: 10.1186/s12986-017-0173-7. eCollection 2017.
PMID: 28270856BACKGROUNDCentner C, Wiegel P, Gollhofer A, Konig D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1.
PMID: 30306467BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Roden, Prof., MD
German Diabetes Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2019
First Posted
January 9, 2020
Study Start
October 28, 2019
Primary Completion
December 31, 2023
Study Completion
March 1, 2024
Last Updated
June 13, 2023
Record last verified: 2023-06