RESIST! Blood-flow Restriction Resistance Training for Improving Insulin Sensitivity in Type 2 Diabetes (RESIST)

June 10, 2023 updated by: German Diabetes Center

Metabolic Effects of a New Resistance Training in Individuals With Type 2 Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes (T2D) is characterized by an increasing insensitivity of muscle, fat and liver cells to the hormone insulin. About 9% of the global population is affected by this condition and mortality risk is twice as high in individuals with diabetes compared to similar-aged people without diabetes.

Muscle is of particular importance for glucose homeostasis, since in healthy people it accounts for 80-90% of postprandial insulin-stimulated glucose disposal. After cellular uptake of glucose by the specialized glucose transporter 4 (GLUT4), glucose is phosphorylated and stored as glycogen. In individuals with obesity or T2D, the capacity for insulin to facilitate glucose uptake and glycogen synthesis is impaired. This reduced response of a given insulin concentration to exert its biological effect is termed insulin resistance. Subsequent diminished insulin secretion due to β-cell failure results in fasting hyperglycemia and overt diabetes. Importantly, muscle insulin resistance is the initial defect occurring in the development of T2D and precedes the clinical development of the disease by up to 20 years.

Thus, the preservation of skeletal muscle function is essential for people with T2D who have an increased risk of sarcopenia. On the one hand high intensity resistance training (HIT) with 80 % one-repetition maximum (%1-RM) is a well-recognized strategy to improve muscle strength and glycemic control for individuals with T2D, on the other hand elderly or obese people may not be able to tolerate these high loads. Blood flow restriction training (BFRT) with low loads (20-30% 1-RM) has consistently demonstrated comparable effects to HIT and seems to be a promising alternative to increase muscle function.

During the BFRT the muscle becomes hypoxic due to a brief occlusion of venous blood flow using a tourniquet while exercising. Consequently metabolites like lactate, growth hormone (GH) and insulin like growth factor (IGF-1) are released and result in muscle hypertrophy through activating the collagen synthesis and the recruitment of satellite cells. Furthermore cell swelling based on venous blood pooling, reactive hyperemia and metabolite accumulation has been shown to increase protein synthesis by activating the mammalian Target of Rapamycin Complex 1 (mTORC1) pathway. Also, BFRT increases the level of reactive oxygen species (ROS) which may lead to higher glucose uptake during exercise. Last but not least higher threshold motor units (fast twitch fibers) are recruited due to hypoxia and metabolite accumulation.

Although there is a significant inverse relationship between muscle strength and the risk of cardiovascular mortality, cardiovascular adaptations to resistance training are under-explored and poorly understood.

The study therefore aims to investigate the metabolic and cardiovascular effects of BFRT with low loads in individuals with T2D.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • NRW
      • Düsseldorf, NRW, Germany, 40225
        • Recruiting
        • German Diabetes Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood-flow restriction resistance training
Resistance training with low loads (15-30% RM) in combination with a brief occlusion of venous blood flow using a tourniquet while exercising.
Other: Blood-flow restriction resistance training
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.
Experimental: Classical resistance training
Resistance training with high loads (60-80% RM).
Other: Classical resistance training
Training program: After warm-up the participant performs three exercises for lower body. The intensity is about 60-80% of 1-RM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insulin sensitivity by blood-flow restriction or classical resistance training
Time Frame: Before and after 12 weeks of training (intervention)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in skeletal muscle mass by blood-flow restriction or classical resistance training
Time Frame: Before and after 12 weeks of training (intervention)
Cross-sectional area (cm2) from quadriceps will be measured by MRI imaging technique to evaluate changes in muscle diameter ("hypertrophy") before and after 12 weeks of resistance training.
Before and after 12 weeks of training (intervention)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in skeletal muscle strength by blood-flow restriction or classical resistance training
Time Frame: Before and after 12 weeks of training (intervention)
Isometric and submaximal strength tests (kg) will be performed to measure changes in muscle strength before and after 12 weeks of resistance training.
Before and after 12 weeks of training (intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Diabetes Center

Investigators

  • Study Director: Michael Roden, Prof., MD, German Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2019

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 10, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDZ_Resist

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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